Acute Myeloid LeukemiaLOYALNCT05166135
Latin American Real-world Study in Acute Leukemia
An observational study of Acute Myeloid Leukemia and Acute Lymphoid Leukemia, run by Pfizer at 14 sites in 4 countries.
Trial summary
The objective of the study is to describe the current epidemiology, treatment patterns, outcomes and healthcare resource use of adult patients diagnosed with relapsed/refractory (R/R) B-cell ALL and de novo AML in 4 Latin American countries. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia
- How many people
- 589 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 10 Dec 2021to 15 Nov 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥18 years old at diagnosis, with de novo AML or R/R B-cell ALL diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for AML or R/R ALL within the study period.
Who may be able to join
- Patients ≥18 years old at diagnosis
- Confirmed diagnosis of relapsed/refractory B-cell ALL or de novo AML diagnosed between 01 January 2015 and 31 December 2019
- At least 1 line of treatment for R/R B-cell ALL or de novo AML within the study period
Who cannot join
- Patients with no medical chart available
- Patients with unreliable data as per investigator's opinion (e.g. excessive missing data or inconsistence data)
- Patients that have participated in any interventional clinical trial for relapsed/refractory B-cell ALL or AML at any moment
- Patients with secondary AML
- Patients with any concomitant primary malignancy
- Patients with acute promyelocytic leukemia (APL)
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Brazil6 sites
Fundação Doutor Amaral Carvalho
Jaú, SAO Paulo / Brazil, 17210-120
Instituto COI de Pesquisa
Rio de Janeiro, 22793-080
Hospital São Rafael
Salvador, Estado de Bahia, 41253-190
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, 01246-000
Hospital Beneficência Portuguesa de São Paulo
São Paulo, 01323-001
Hospital Israelita Albert Einstein
São Paulo, 05652000
Argentina5 sites
FUNDALEU - Fundacion para combatir la Leucemia
Buenos Aires, Ciudad Autonoma Buenos Aires, 1114
Hospital Privado Centro Medico de Cordoba S.A.
Córdoba, 5016
Sanatorio Allende
Córdoba, X5000JHQ
Hospital Italiano de La Plata
La Plata, Buenos Aires, B1900AXI
Hospital Universitario Austral
Pilar, Buenos Aires, B1629ODT
Colombia2 sites
Fundacion Santa Fe de Bogota
Bogotá, 111071
Oncomedica SA
Montería, 230002
About this study
Official title: Real-world Study in Acute Leukemia: Epidemiology, Treatment Patterns and Outcomes for B-cell ALL and AML in Adult Patients From Latin America - LOYAL Study
The objective of the study is to describe the current epidemiology, treatment patterns, outcomes and healthcare resource use of adult patients diagnosed with relapsed/refractory (R/R) B-cell ALL and de novo AML in 4 Latin American countries.
Read the detailed description
This is a retrospective multicenter non-interventional study using real-world data collected from medical records of newly diagnosed AML or with relapsed/refractory B-cell ALL diagnosed between 01 January 2015 and 31 December 2019 in 4 Latin American countries: Argentina, Brazil, Chile, and Colombia. In addition, as secondary objectives, the study will also describe molecular profile, cytogenetic risk, clinical outcomes, and healthcare resource utilization of treated B-cell ALL R/R and AML patients.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia
- Keywords
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Relapsed Refractory B-cell Acute Lymphoblastic Leukemia, Acute Leukemia in Latin America, LOYAL study
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute Myeloid Leukemia | Patients ≥18 years old at diagnosis, with de novo AML diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for AML within the study period. | |
| Relapsed/Refractory Acute Lymphoid Leukemia | Patients ≥18 years old at diagnosis, with R/R ALL diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for R/R ALL within the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants According to Health Insurance Type
Number of participants according to type of health insurance (public or private) were reported in this outcome measure.
Measured: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of Participants According to Country of Residence
Number of participants according to country of residence such as Argentina, Brazil, Chile, and Colombia were reported in this outcome measure.
Measured: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of Participants With Comorbidities
Number of participants with any comorbidity at de novo AML or B-cell ALL diagnosis were reported in this outcome measure.
Measured: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of Participants According to Family History of Hematological Malignancies
Number of participants who had a family history of hematological malignancies were reported in this outcome measure.
Measured: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of Participants With Prior Exposure to Toxic Agents
Number of participants who had any prior exposure to toxic agents were reported in this outcome measure.
Measured: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of Participants With Prior Exposure to a High Dose of Radiation
Number of participants with prior exposure to a high dose of radiation were reported in this outcome measure.
Measured: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of Participants According to Reason for Exposure to High Dose of Radiation
Number of participants according to reason for exposure to high dose of radiation were reported in this outcome measure.
Measured: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of Participants With Bleeding History
Number of participants with bleeding history were reported in this outcome measure.
Measured: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of Participants With Tobacco Consumption Habits
Participants with tobacco consumption habits (i.e., Non-smoker, Ex-smoker and others) were reported in this outcome measure.
Measured: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores
ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, 2, 3 and 4) was reported.
Measured: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of Participants According to Karnofsky Performance Scores
Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score was 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Score:100=normal no complaints; no disease evidence,90=able to carry normal activity; minor signs/symptoms of disease,80=normal activity with effort; some signs/symptoms, 70=cares for self; unable to carry normal activity, 60=required occasional assistance, able to care for personal needs, 50=required considerable assistance \& frequent medical care, 40=disabled; required special care/assistance,30=severely disabled; hospital admission indicated;20=very sick; hospital admission necessary,10=moribund and 0=dead.
Measured: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of Participants According to Year of Diagnosis
Number of participants according to the year of diagnosis for newly AML or R/R B-cell ALL were reported in this outcome measure.
Measured: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of Participants According to Classification for Standard Newly AML Therapy
Number of participants classified as fit or unfit for the standard newly AML therapy according to different lines of treatment (LOT) were reported in this outcome measure.
Measured: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Drug Regimen Prescribed for Newly AML
A regimen was defined as a plan for the dose, schedule, and length of treatment. A regimen could be a treatment that consisted of one or combined (two or more) drugs. Number of participants according to drug regimen prescribed for newly AML were reported by each line of treatment (LOT). Drug regimen included standard 7+3, Histone deacetylases (HDACs), Low-dose Cytarabine (LDAC), FLAG (fludarabine + high-dose cytarabine + G-CSF (Granulocyte colony-stimulating factor), FLAG-IDA Regimen (Fludarabine, Cytarabine, Idarubicin and G-CSF), Hypomethylating agents (HMA), CLAG (Cladribine + Cytarabine + G-CSF), MEC (mitoxantrone, etoposide and intermediate dose cytarabine), MICE and other.
Measured: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
A regimen was defined as a plan for the dose, schedule, and length of treatment. A regimen could be a treatment that consisted of one or combined (two or more) drugs. Number of participants according to drug regimen prescribed for R/R B-cell ALL were reported by each LOT is reported. Drug regimen included Hyper- CVAD (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and prednisolone), German multicenter study group for ALL (GMALL), Group for Research on Adult Acute Lymphoblastic Leukemia (GRAAL), Berlin-Frankfurt-Münster (BFM), Inotuzumab, Blinatumomab, Chimeric antigen receptor T-cell therapies (CAR-T), Tyrosine kinase inhibitors (TKI), FLAG (fludarabine + high-dose cytarabine + G-CSF), FLAG-IDA Regimen (Fludarabine, Cytarabine, Idarubicin and G-CSF), Other. One participant could be prescribed more than 1 drug regimen.
Measured: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Number of participants prescribed Gemtuzumab, Midostaurin or Venetoclax treatment in newly AML according to different LOT were reported in this outcome measure.
Measured: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Regimen Type in Newly AML
Number of participants according to drug regimen prescribed for newly AML is reported by each LOT. Induction was the first phase of treatment. Consolidation was given after the participant had recovered from induction. Maintenance was given to maintain the remission and further prevent a relapse. Salvage was used when a disease did not respond to all other standard treatments tried.
Measured: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Treatment Duration
The duration of treatment according to different treatment lines were reported.
Measured: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Time to Next Treatment
Time to next treatment was considered as the time from the start date of the front-line therapy to the start date of a subsequent line of therapy. Participants without a subsequent line of therapy were censored at study enrollment, last visit, last contact, or death, whichever comes first.
Measured: From start of front-line therapy until start of subsequent line of therapy, last visit/contact/death (up to maximum of 94.6 months);data collected and observed retrospectively over 11 month
Total Number of Cycles
Total number of cycles according to each line of treatment is reported in this outcome measure.
Measured: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants Who Withdrew Regimen
Number of participants who withdrew regimen according to each line of treatment is reported in this outcome measure.
Measured: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Reasons for Withdrawing Regimen
Number of participants according to reasons such as progression of the disease, Adverse event toxicity, participants refusal to continue the treatment scheme, cost related or access barriers and other for withdrawing regimen according to each line of treatment were reported in this outcome measure. One participant could have more than one reason for withdrawing regimen.
Measured: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants With Dose Reduction
Number of participants with dose reduction according to each line of treatment were reported in this outcome measure.
Measured: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression
Number of participants with CNS involvement at disease progression according to each line of treatment were reported in this outcome measure.
Measured: At disease progression (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Duration of Radiotherapy
Mean duration of radiotherapy according to each line of treatment is reported in this outcome measure.
Measured: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Dose of Radiotherapy
Mean dose of radiotherapy according to each line of treatment is reported in this outcome measure.
Measured: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Location of Application of Radiotherapy
Number of participants according to location of application of radiotherapy according to each line of treatment is reported in this outcome measure.
Measured: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Intrathecal Chemotherapy
Number of participants according to intrathecal chemotherapy such as methotrexate, cytarabine, prednisone, dexamethasone, other according to each line of treatment is reported in this outcome measure. One participant may receive more than one intrathecal chemotherapy.
Measured: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants With Stem Cell Transplant (SCT)
Number of participants with stem cell transplant were reported in this outcome measure.
Measured: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Absolute Value of Hemoglobin Before Treatment Line
Absolute value of hemoglobin before start of treatment according to each line of treatment was reported in this outcome measure.
Measured: Up to 48 hours before each treatment cycle till the end of treatment, disease progression and/or death from any cause; data collected and observed retrospectively over 11 months
Absolute Value of Hemoglobin After Start of Treatment Line
Absolute value of hemoglobin after start of treatment according to each line of treatment was reported in this outcome measure.
Measured: After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Absolute Value of White Blood Cell Count Before Treatment Line
Absolute value of white blood cell count before start of treatment according to each line of treatment was reported in this outcome measure.
Measured: Up to 48 hours before each treatment cycle till the end of treatment, disease progression and/or death from any cause; data collected and observed retrospectively over 11 months
Absolute Value of White Blood Cell Count After Start of Treatment Line
Absolute value of white blood cell count after start of treatment according to each line of treatment was reported in this outcome measure.
Measured: After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Absolute Neutrophil Count (ANC) Before Treatment Line
Absolute value of neutrophil count before start of treatment according to each line of treatment was reported in this outcome measure.
Measured: Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months
Absolute Neutrophil Count (ANC) After Start of Treatment Line
Absolute value of neutrophil count after start of treatment according to each line of treatment was reported in this outcome measure.
Measured: After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Absolute Value of Blast Count Before Treatment Line
Absolute value of blast count before start of treatment according to each line of treatment was reported in this outcome measure.
Measured: Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months
Absolute Value of Blast Count After Start of Treatment Line
Absolute value of blast count after start of treatment according to each line of treatment was reported in this outcome measure.
Measured: After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Absolute Value of Platelets Count Before Treatment Line
Absolute value of platelet count before start of treatment according to each line of treatment was reported in this outcome measure.
Measured: Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months
Absolute Value of Platelets Count After Start of Treatment Line
Absolute value of platelet count after start of treatment according to different treatment lines were reported.
Measured: After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Secondary outcomes (25)
Number of Participants With Molecular Test Performed
Number of participants with different molecular test KGB, Fluorescence in situ hybridization (FISH), Reverse transcription polymerase chain reaction (RT-PCR), Next-generation sequencing (NGS), Array Comparative Genomic Hybridization (ACGH), Other performed were reported.
Measured: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to AML Translocation Results: AML Arm Only
Number of participants according to different AML translocation were reported in this outcome measure.
Measured: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 months
Number of Participants According to Molecular Profile in Newly AML Arm
Number of participants according to molecular profile were reported in this outcome measure.
Measured: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 months
Number of Participants According to AML WHO Classification: AML Arm Only
Number of participants according to AML WHO classification were reported in this outcome measure.
Measured: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only
Number of participants according to ALL WHO classification were reported in this outcome measure.
Measured: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Immunophenotyping Results for AML Arm Only
Number of participants according to immunophenotyping assessment results were reported for AML arm in this outcome measure.
Measured: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Immunophenotyping Results for R/R B-cell ALL
Number of participants according to immunophenotyping assessment results were reported for R/R B-cell ALL arm in this outcome measure.
Measured: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Molecular Profile in R/R B-cell ALL
Number of participants according to molecular profile in R/R B-cell ALL were reported.
Measured: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only
A good prognosis means that there was a high chance of recovery or healing. Intermediate prognosis was a term used to describe the likelihood of recovery or survival from a disease or condition that was neither favorable nor unfavorable. A poor prognosis refers to an estimation that there was a low chance of recovery from a disease.
Measured: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN)
Number of participants according to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN)" under favorable (indicates a low probability or impact of adverse outcomes), intermediate (associated with moderate changes) and Poor/ Adverse (occurrence of a risk was high and the impact of the risk is severe) were reported.
Measured: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL
A regimen could be a treatment that consisted of one or combined (two or more) drugs. Number of participants according to drug regimen prescribed for R/R B-cell ALL is reported. Hyper- CVAD (hyper fractionated cyclophosphamide, vincristine, doxorubicin, and prednisolone), German multicenter ALL (GMALL), GRAAL, Berlin-Frankfurt-Münster (BFM), Inotuzumab, Blinatumomab Chimeric antigen receptor T-cell therapies (CAR-T), Tyrosine kinase inhibitors (TKI), FLAG (fludarabine + high-dose cytarabine + G-CSF), FLAG-IDA Regimen (Fludarabine, Cytarabine, Idarubicin and G-CSF). The initial diagnosis of acute leukemia could have been before 01-Jan-2015.
Measured: From the diagnosis for de novo ALL diagnosis date to study enrolment date (anytime between 2001-2014 approximately 13 years); data collected and observed retrospectively over 11 months
Time From Start of First-Line Treatment to Start of the Adverse Event
Time from start of first line treatment to start of the adverse event were reported. An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: From start of 1st line treatment until Adverse Event (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Clinical Events
Number of clinical events were reported in this outcome measure.
Measured: From diagnosis until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Event Free Survival (EFS)
EFS =time since treatment initiation until failure to achieve complete remission (CR) or disease progression (PD) after CR, or death from any cause. Participants not known to have any of these events were censored on the date they were last examined, study enrollment, last contact, whichever came later.CR=participants response to treatment according to the medical chart. AML CR =no physical signs of leukemia, bone marrow with active hematopoiesis, <5% bone marrow blasts and more than 1* 10^9 cells/l granulocytes and more than 100* 10^9 cells/l platelets in the blood and no circulating leukemic blasts or evidence of extramedullary leukemia), PD=according to medical chart and accompanied by a decline in absolute neutrophil count (ANC) and platelets and increased transfusion requirement and decline in performance status or increase in symptoms.
Measured: From start of treatment until failure to achieve CR, PD or death or censoring date (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Overall Survival (OS)
OS was defined as the time from the date of diagnosis or treatment until date of death due to any cause. If there was no death, the participants were censored at last visit or contact, whichever came later.
Measured: From start of treatment until disease progression, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation
Percentage of participants alive at 1,3 and 5 years since treatment initiation were reported in this outcome measure.
Measured: 1, 3 and 5 years since treatment initiation; data collected and observed retrospectively over 11 months
Relapse Free Survival-Newly Diagnosed AML Participants Only
Relapse was a deterioration in health status after an improvement. Relapse free survival was considered as date of achievement of a remission until the date of relapse or death from any cause; participants not known to have relapsed or died at last follow-up were censored on the date they were last examined. CR=a participant's response to treatment according to the medical chart. Usually, AML complete remission defined as no physical signs of leukemia, bone marrow with active hematopoiesis, <5% bone marrow blasts and more than 1* 10^9 cells/L granulocytes and more than 100* 10^9 cells/L platelets in the blood and no circulating leukemic blasts or evidence of extramedullary leukemia.
Measured: From date of remission until relapse or death or censoring date (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Treatment Response
Complete remission-response (CR) defined as no physical signs of leukemia, bone marrow with active hematopoiesis, <5% bone marrow blasts and more than 1×109/l granulocytes and more than 100×109/l platelets in blood and no circulating leukemic blasts or evidence of extramedullary leukemia. Complete response with incomplete blood count recovery (CRi): also known as CR with incomplete hematologic recovery, participant's response to treatment according to medical chart. Partial remission: participant's response to treatment according to medical chart. All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; decrease of pretreatment bone marrow blast percentage by at least 50%. Disease progression: >25% increase in sum of longest diameter of target lesions compared to baseline. Refractory disease: according to medical chart. No CR after 2 courses of intensive induction treatment; excluding participants with death in aplasia or death due to indeterminate cause.
Measured: From start of treatment until disease progression, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Hospitalizations
Number of hospitalizations were reported in this outcome measure. One participant could have more than one hospitalization.
Measured: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Reason for Hospitalization
Reason for hospitalizations according to reasons such as ALL-AML treatment, adverse events were reported. One participant could have more than one reason for hospitalization.
Measured: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Duration in Intensive Care Unit
Mean duration in intensive care unit were reported in this outcome measure.
Measured: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Procedures
Different clinical procedures were reported. One participant could have more than one procedure.
Measured: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Surgery
Number of participants according to type of surgery were reported in this outcome measure.
Measured: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Blood Transfusions
Number and type of blood transfusions were reported in this outcome measure. One participant could have more than one blood transfusions.
Measured: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Concomitant Medications
Concomitant medication: drug treatment for comorbidities, supportive and prophylaxis therapies, or to treat adverse events.
Measured: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start10 Dec 2021
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 589 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166135
- Sponsor's protocol ID
- X9001302
- Other IDs
- LOYAL
- Acronym
- LOYAL
- Status last verified
- Mar 2025
- First submitted
- 10 Nov 2021
- Last updated
- 25 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study in Acute Leukemia: Epidemiology, Treatment Patterns and Outcomes for B-cell ALL and AML in Adult Patients From Latin America - LOYAL Study
- ClinicalTrials.gov ID
- NCT05166135
- Acronym / sponsor ID
- LOYAL / X9001302
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia
- Keywords
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Relapsed Refractory B-cell Acute Lymphoblastic Leukemia, Acute Leukemia in Latin America, LOYAL study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 589 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Posted 25 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to describe the current epidemiology, treatment patterns, outcomes and healthcare resource use of adult patients diagnosed with relapsed/refractory (R/R) B-cell ALL and de novo AML in 4 Latin American countries.
Detailed description
This is a retrospective multicenter non-interventional study using real-world data collected from medical records of newly diagnosed AML or with relapsed/refractory B-cell ALL diagnosed between 01 January 2015 and 31 December 2019 in 4 Latin American countries: Argentina, Brazil, Chile, and Colombia. In addition, as secondary objectives, the study will also describe molecular profile, cytogenetic risk, clinical outcomes, and healthcare resource utilization of treated B-cell ALL R/R and AML patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Myeloid Leukemia | – | –Patients ≥18 years old at diagnosis, with de novo AML diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for AML within the study period. |
| Relapsed/Refractory Acute Lymphoid Leukemia | – | –Patients ≥18 years old at diagnosis, with R/R ALL diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for R/R ALL within the study period. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥18 years old at diagnosis, with de novo AML or R/R B-cell ALL diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for AML or R/R ALL within the study period.
Key inclusion criteria (3 listed)
- Patients ≥18 years old at diagnosis
- Confirmed diagnosis of relapsed/refractory B-cell ALL or de novo AML diagnosed between 01 January 2015 and 31 December 2019
- At least 1 line of treatment for R/R B-cell ALL or de novo AML within the study period
Key exclusion criteria (6 listed)
- Patients with no medical chart available
- Patients with unreliable data as per investigator's opinion (e.g. excessive missing data or inconsistence data)
- Patients that have participated in any interventional clinical trial for relapsed/refractory B-cell ALL or AML at any moment
- Patients with secondary AML
- Patients with any concomitant primary malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants According to Health Insurance Type
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of participants according to type of health insurance (public or private) were reported in this outcome measure.
Number of Participants According to Country of Residence
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of participants according to country of residence such as Argentina, Brazil, Chile, and Colombia were reported in this outcome measure.
Number of Participants With Comorbidities
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of participants with any comorbidity at de novo AML or B-cell ALL diagnosis were reported in this outcome measure.
Number of Participants According to Family History of Hematological Malignancies
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of participants who had a family history of hematological malignancies were reported in this outcome measure.
Number of Participants With Prior Exposure to Toxic Agents
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of participants who had any prior exposure to toxic agents were reported in this outcome measure.
Number of Participants With Prior Exposure to a High Dose of Radiation
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of participants with prior exposure to a high dose of radiation were reported in this outcome measure.
Number of Participants According to Reason for Exposure to High Dose of Radiation
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of participants according to reason for exposure to high dose of radiation were reported in this outcome measure.
Number of Participants With Bleeding History
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of participants with bleeding history were reported in this outcome measure.
Number of Participants With Tobacco Consumption Habits
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Participants with tobacco consumption habits (i.e., Non-smoker, Ex-smoker and others) were reported in this outcome measure.
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, 2, 3 and 4) was reported.
Number of Participants According to Karnofsky Performance Scores
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score was 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Score:100=normal no complaints; no disease evidence,90=able to carry normal activity; minor signs/symptoms of disease,80=normal activity with effort; some signs/symptoms, 70=cares for self; unable to carry normal activity, 60=required occasional assistance, able to care for personal needs, 50=required considerable assistance \& frequent medical care, 40=disabled; required special care/assistance,30=severely disabled; hospital admission indicated;20=very sick; hospital admission necessary,10=moribund and 0=dead.
Number of Participants According to Year of Diagnosis
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Number of participants according to the year of diagnosis for newly AML or R/R B-cell ALL were reported in this outcome measure.
Number of Participants According to Classification for Standard Newly AML Therapy
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of participants classified as fit or unfit for the standard newly AML therapy according to different lines of treatment (LOT) were reported in this outcome measure.
Number of Participants According to Drug Regimen Prescribed for Newly AML
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
A regimen was defined as a plan for the dose, schedule, and length of treatment. A regimen could be a treatment that consisted of one or combined (two or more) drugs. Number of participants according to drug regimen prescribed for newly AML were reported by each line of treatment (LOT). Drug regimen included standard 7+3, Histone deacetylases (HDACs), Low-dose Cytarabine (LDAC), FLAG (fludarabine + high-dose cytarabine + G-CSF (Granulocyte colony-stimulating factor), FLAG-IDA Regimen (Fludarabine, Cytarabine, Idarubicin and G-CSF), Hypomethylating agents (HMA), CLAG (Cladribine + Cytarabine + G-CSF), MEC (mitoxantrone, etoposide and intermediate dose cytarabine), MICE and other.
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
A regimen was defined as a plan for the dose, schedule, and length of treatment. A regimen could be a treatment that consisted of one or combined (two or more) drugs. Number of participants according to drug regimen prescribed for R/R B-cell ALL were reported by each LOT is reported. Drug regimen included Hyper- CVAD (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and prednisolone), German multicenter study group for ALL (GMALL), Group for Research on Adult Acute Lymphoblastic Leukemia (GRAAL), Berlin-Frankfurt-Münster (BFM), Inotuzumab, Blinatumomab, Chimeric antigen receptor T-cell therapies (CAR-T), Tyrosine kinase inhibitors (TKI), FLAG (fludarabine + high-dose cytarabine + G-CSF), FLAG-IDA Regimen (Fludarabine, Cytarabine, Idarubicin and G-CSF), Other. One participant could be prescribed more than 1 drug regimen.
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of participants prescribed Gemtuzumab, Midostaurin or Venetoclax treatment in newly AML according to different LOT were reported in this outcome measure.
Number of Participants According to Regimen Type in Newly AML
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of participants according to drug regimen prescribed for newly AML is reported by each LOT. Induction was the first phase of treatment. Consolidation was given after the participant had recovered from induction. Maintenance was given to maintain the remission and further prevent a relapse. Salvage was used when a disease did not respond to all other standard treatments tried.
Treatment Duration
Time frame: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
The duration of treatment according to different treatment lines were reported.
Time to Next Treatment
Time frame: From start of front-line therapy until start of subsequent line of therapy, last visit/contact/death (up to maximum of 94.6 months);data collected and observed retrospectively over 11 month
Time to next treatment was considered as the time from the start date of the front-line therapy to the start date of a subsequent line of therapy. Participants without a subsequent line of therapy were censored at study enrollment, last visit, last contact, or death, whichever comes first.
Total Number of Cycles
Time frame: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Total number of cycles according to each line of treatment is reported in this outcome measure.
Number of Participants Who Withdrew Regimen
Time frame: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of participants who withdrew regimen according to each line of treatment is reported in this outcome measure.
Number of Participants According to Reasons for Withdrawing Regimen
Time frame: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of participants according to reasons such as progression of the disease, Adverse event toxicity, participants refusal to continue the treatment scheme, cost related or access barriers and other for withdrawing regimen according to each line of treatment were reported in this outcome measure. One participant could have more than one reason for withdrawing regimen.
Number of Participants With Dose Reduction
Time frame: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of participants with dose reduction according to each line of treatment were reported in this outcome measure.
Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression
Time frame: At disease progression (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of participants with CNS involvement at disease progression according to each line of treatment were reported in this outcome measure.
Duration of Radiotherapy
Time frame: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Mean duration of radiotherapy according to each line of treatment is reported in this outcome measure.
Dose of Radiotherapy
Time frame: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Mean dose of radiotherapy according to each line of treatment is reported in this outcome measure.
Number of Participants According to Location of Application of Radiotherapy
Time frame: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of participants according to location of application of radiotherapy according to each line of treatment is reported in this outcome measure.
Number of Participants According to Intrathecal Chemotherapy
Time frame: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of participants according to intrathecal chemotherapy such as methotrexate, cytarabine, prednisone, dexamethasone, other according to each line of treatment is reported in this outcome measure. One participant may receive more than one intrathecal chemotherapy.
Number of Participants With Stem Cell Transplant (SCT)
Time frame: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of participants with stem cell transplant were reported in this outcome measure.
Absolute Value of Hemoglobin Before Treatment Line
Time frame: Up to 48 hours before each treatment cycle till the end of treatment, disease progression and/or death from any cause; data collected and observed retrospectively over 11 months
Absolute value of hemoglobin before start of treatment according to each line of treatment was reported in this outcome measure.
Absolute Value of Hemoglobin After Start of Treatment Line
Time frame: After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Absolute value of hemoglobin after start of treatment according to each line of treatment was reported in this outcome measure.
Absolute Value of White Blood Cell Count Before Treatment Line
Time frame: Up to 48 hours before each treatment cycle till the end of treatment, disease progression and/or death from any cause; data collected and observed retrospectively over 11 months
Absolute value of white blood cell count before start of treatment according to each line of treatment was reported in this outcome measure.
Absolute Value of White Blood Cell Count After Start of Treatment Line
Time frame: After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Absolute value of white blood cell count after start of treatment according to each line of treatment was reported in this outcome measure.
Absolute Neutrophil Count (ANC) Before Treatment Line
Time frame: Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months
Absolute value of neutrophil count before start of treatment according to each line of treatment was reported in this outcome measure.
Absolute Neutrophil Count (ANC) After Start of Treatment Line
Time frame: After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Absolute value of neutrophil count after start of treatment according to each line of treatment was reported in this outcome measure.
Absolute Value of Blast Count Before Treatment Line
Time frame: Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months
Absolute value of blast count before start of treatment according to each line of treatment was reported in this outcome measure.
Absolute Value of Blast Count After Start of Treatment Line
Time frame: After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Absolute value of blast count after start of treatment according to each line of treatment was reported in this outcome measure.
Absolute Value of Platelets Count Before Treatment Line
Time frame: Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months
Absolute value of platelet count before start of treatment according to each line of treatment was reported in this outcome measure.
Absolute Value of Platelets Count After Start of Treatment Line
Time frame: After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Absolute value of platelet count after start of treatment according to different treatment lines were reported.
25 secondary outcomes
Number of Participants With Molecular Test Performed
Time frame: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to AML Translocation Results: AML Arm Only
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 months
Number of Participants According to Molecular Profile in Newly AML Arm
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 months
Number of Participants According to AML WHO Classification: AML Arm Only
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only
Time frame: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Immunophenotyping Results for AML Arm Only
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Immunophenotyping Results for R/R B-cell ALL
Time frame: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Molecular Profile in R/R B-cell ALL
Time frame: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only
Time frame: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN)
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL
Time frame: From the diagnosis for de novo ALL diagnosis date to study enrolment date (anytime between 2001-2014 approximately 13 years); data collected and observed retrospectively over 11 months
Time From Start of First-Line Treatment to Start of the Adverse Event
Time frame: From start of 1st line treatment until Adverse Event (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Clinical Events
Time frame: From diagnosis until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Event Free Survival (EFS)
Time frame: From start of treatment until failure to achieve CR, PD or death or censoring date (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Overall Survival (OS)
Time frame: From start of treatment until disease progression, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation
Time frame: 1, 3 and 5 years since treatment initiation; data collected and observed retrospectively over 11 months
Relapse Free Survival-Newly Diagnosed AML Participants Only
Time frame: From date of remission until relapse or death or censoring date (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Treatment Response
Time frame: From start of treatment until disease progression, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Hospitalizations
Time frame: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Reason for Hospitalization
Time frame: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Duration in Intensive Care Unit
Time frame: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Procedures
Time frame: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Surgery
Time frame: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Blood Transfusions
Time frame: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Concomitant Medications
Time frame: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Acute Lymphoid Leukemia, run by Pfizer at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Brazil, Argentina, Colombia, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants According to Health Insurance Type (time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.