Acute Lymphoblastic Leukemia, AdultNCT05127148
RWE of Pediatric-like Protocol for AYA Patients With Ph-negative ALL
An observational study of Acute Lymphoblastic Leukemia, Adult, run by Grupo Argentino de Tratamiento de la Leucemia Aguda at 2 sites in Argentina.
Trial summary
This is a multicenter, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of adolescent and young patients with ph-negative acute lymphoblastic leukemia with first-line pediatric-like protocol in Argentina. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Adult
- What is being tested?
- Evaluation of survival and toxicities in AYA Ph-negative ALL patients treating in first line depending on risk category.
- How many people
- 100 participants
- Where
- 2 sitesArgentina
- Study dates
- 1 Mar 2021to 1 Dec 2026
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Adult
Study population: All AYA (18-40 years old) with recent diagnosis of ph-negative ALL without previous treatment.
Who may be able to join
- Signature of the form consent for participation in the study
- Ph-negative ALL diagnosis without previous treatment.
Who cannot join
- ALL with mature B phenotype (sIg +) or with the cytogenetic alterations characteristic of ALL mature B (t (8,14), t (2, 8), t (8, 22)).
- Ph-positive ALL
- Acute leukemias of ambiguous lineage (undifferentiated or mixed phenotype).
- Patients with a history of coronary, valvular or hypertensive heart disease, that contraindicate the use of anthracyclines.
- Patients with chronic liver disease in the activity phase and / or Bilirubin> 2 mg / dl and / or transaminases 5 times the normal limit, not related to ALL.
- Patients with severe chronic respiratory failure.
Show all 12Show fewer
- Renal failure and / or creatininemia> 2 mg / dl not related to ALL.
- Serious neurological disorders, not related to leukemic disease.
- General condition affected (grades 3 and 4), not attributable to ALL.
- Uncontrolled infection by HIV, HTLV-1, HBV, HCV.
- Patient not a candidate for treatment based on the criteria of the treating physician.
- Pregnant women will have to be evaluated by a multidisciplinary team and an ethics committee.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina2 sites, 2 recruiting
- Recruiting
FUNDALEU
CABA
Luciana Ferrari, Dr., 541148771000, lferrari@fundaleu.org.ar
- Recruiting
Instituto Privado de Hematologia y Hemoterapia
Paraná, Entre Ríos Province
Pedro Negri Aranguren, Dr.
Florencia Negri Aranguren, Dr.
About this study
Official title: Real-world Evidence of First-line Treatment With Pediatric-like Protocol for Adolescents and Young Adults Patients Diagnosed With Philadelphia-negative Acute Lymphoblastic Leukemia
This is a multicenter, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of adolescent and young patients with ph-negative acute lymphoblastic leukemia with first-line pediatric-like protocol in Argentina.
Read the detailed description
The purpose of this trial is to gather real world evidence of treatment outcomes and toxicities of AYA Ph-negative ALL patients in Argentina who receive pediatric-like treatment in first line.
The study primary endpoints are to evaluate survival (event free survival and overall survival) and toxicities of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
Secondary endpoints are to evaluate survival in patients who underwent allogeneic transplantation in first remission, asparaginase toxicities, and assess central cerebrospinal fluid by flow cytometry.
Every ALL patient diagnosed in our institutions will follow our guidelines with respect to diagnosis procedures.
High-risk (HR) group was defined as presenting high risk cytogenetics/molecular findings and depending on the response achieved at different time points: bad response to prednisone at day 8, ≥ 10% blast in bone marrow on day 15, minimal residual disease (MRD) by flow cytometry ≥0.1% at day 33 and ≥0.01% at day 78 in bone marrow. No-high risk group was defined as those without any high-risk factor.
The chemotherapy regimen included pre-induction phase, induction (phase I and II), consolidation, re-intensification, central nervous system (CNS) prophylaxis and maintenance therapy or ASCT in first remission .
The initial pre-induction phase, where steroids were given for 7 days. Induction therapy, phase IA consisted of weekly vincristine and daunorubicin for 4 weeks, L-Asparaginase for 8 doses or peg-asparaginase for 2 doses and prednisone continuously for 4 weeks. Phase IB consisted cytarabine for 16 doses, cyclophosphamide for 1-2 doses and 6-mercaptopurine for 28 days.
The consolidation phase consisted of 4 doses of methotrexate and 6-mercaptopurine for 56 days for Non-High Risk patients (M phase) and two cycles of three different blocks of high dose multi chemotherapy for HR patients. Re-induction consisted in two phases similar to induction. According to risk and response to treatment, patients will be candidates to maintenance for 18 months or ASCT in first remission.
Minimal residual disease will be evaluated at least on day 33, 78, in consolidation and every thee months during maintenance treatment or previous to ASCT.
- Conditions
- Acute Lymphoblastic Leukemia, Adult
- Being tested
- Evaluation of survival and toxicities in AYA Ph-negative ALL patients treating in first line depending on risk category.
- Keywords
- Acute Lymphoblastic Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of survival and toxicities in AYA Ph-negative ALL patients treating in first line depending on risk category.Other
Evaluation of survival (event free survival and overall survival) and toxicities in AYA Ph-negative ALL patients treating in first line with argentinian pediatric-like protocol depending on risk category.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents and young adults Ph-negative ALL patients in first-line | Adolescents and young adults patients (18-40 years old) with recent diagnosis of Ph-negative acute lymphoblastic leukemia who receive argentinian pediatric-like treatment depending on risk category. Receives: Other: Evaluation of survival and toxicities in AYA Ph-negative ALL patients treating in first line depending on risk category. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate event free survival of AYA Ph-negative ALL patients treating in first line depending on risk category.
Evaluate event free survival of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
Measured: 36 months
Evaluate overall survival of AYA Ph-negative ALL patients treating in first line depending on risk category.
Evaluate overall survival of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
Measured: 36 months
Evaluate toxicities of AYA Ph-negative ALL patients treating in first line depending on risk category.
Evaluate toxicities of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
Measured: 36 months
Secondary outcomes (3)
Evaluate survival in patients who underwent allogeneic transplantation in first remission
Measured: 36 months
Evaluate asparaginase toxicities.
Measured: 36 months
Assess central cerebrospinal fluid involvement by flow cytometry.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, AdultStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Grupo Argentino de Tratamiento de la Leucemia Aguda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Moirano, Dr., Principal investigator, Grupo Argentino de Tratamiento de la Leucemia AgudaIsolda Fernández, Dr., Study chair, Grupo Argentino de Tratamiento de la Leucemia AgudaLuciana Ferrari, Dr., Principal investigator, Grupo Argentino de Tratamiento de la Leucemia Aguda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127148
- Sponsor's protocol ID
- GATLA 11-LLA Ph(-)-20 AYA
- Status last verified
- Jan 2024
- First submitted
- 9 Nov 2021
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share study protocol
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evidence of First-line Treatment With Pediatric-like Protocol for Adolescents and Young Adults Patients Diagnosed With Philadelphia-negative Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05127148
- Acronym / sponsor ID
- GATLA 11-LLA Ph(-)-20 AYA
- Conditions
- Acute Lymphoblastic Leukemia, Adult
- Keywords
- Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Grupo Argentino de Tratamiento de la Leucemia AgudaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of adolescent and young patients with ph-negative acute lymphoblastic leukemia with first-line pediatric-like protocol in Argentina.
Detailed description
The purpose of this trial is to gather real world evidence of treatment outcomes and toxicities of AYA Ph-negative ALL patients in Argentina who receive pediatric-like treatment in first line.
The study primary endpoints are to evaluate survival (event free survival and overall survival) and toxicities of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
Secondary endpoints are to evaluate survival in patients who underwent allogeneic transplantation in first remission, asparaginase toxicities, and assess central cerebrospinal fluid by flow cytometry.
Every ALL patient diagnosed in our institutions will follow our guidelines with respect to diagnosis procedures.
High-risk (HR) group was defined as presenting high risk cytogenetics/molecular findings and depending on the response achieved at different time points: bad response to prednisone at day 8, ≥ 10% blast in bone marrow on day 15, minimal residual disease (MRD) by flow cytometry ≥0.1% at day 33 and ≥0.01% at day 78 in bone marrow. No-high risk group was defined as those without any high-risk factor.
The chemotherapy regimen included pre-induction phase, induction (phase I and II), consolidation, re-intensification, central nervous system (CNS) prophylaxis and maintenance therapy or ASCT in first remission .
The initial pre-induction phase, where steroids were given for 7 days. Induction therapy, phase IA consisted of weekly vincristine and daunorubicin for 4 weeks, L-Asparaginase for 8 doses or peg-asparaginase for 2 doses and prednisone continuously for 4 weeks. Phase IB consisted cytarabine for 16 doses, cyclophosphamide for 1-2 doses and 6-mercaptopurine for 28 days.
The consolidation phase consisted of 4 doses of methotrexate and 6-mercaptopurine for 56 days for Non-High Risk patients (M phase) and two cycles of three different blocks of high dose multi chemotherapy for HR patients. Re-induction consisted in two phases similar to induction. According to risk and response to treatment, patients will be candidates to maintenance for 18 months or ASCT in first remission.
Minimal residual disease will be evaluated at least on day 33, 78, in consolidation and every thee months during maintenance treatment or previous to ASCT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents and young adults Ph-negative ALL patients in first-line | – | Other: Evaluation of survival and toxicities in AYA Ph-negative ALL patients treating in first line depending on risk category.Adolescents and young adults patients (18-40 years old) with recent diagnosis of Ph-negative acute lymphoblastic leukemia who receive argentinian pediatric-like treatment depending on risk category. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- All AYA (18-40 years old) with recent diagnosis of ph-negative ALL without previous treatment.
Key inclusion criteria (2 listed)
- Signature of the form consent for participation in the study
- Ph-negative ALL diagnosis without previous treatment.
Key exclusion criteria (12 listed)
- ALL with mature B phenotype (sIg +) or with the cytogenetic alterations characteristic of ALL mature B (t (8,14), t (2, 8), t (8, 22)).
- Ph-positive ALL
- Acute leukemias of ambiguous lineage (undifferentiated or mixed phenotype).
- Patients with a history of coronary, valvular or hypertensive heart disease, that contraindicate the use of anthracyclines.
- Patients with chronic liver disease in the activity phase and / or Bilirubin> 2 mg / dl and / or transaminases 5 times the normal limit, not related to ALL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of survival and toxicities in AYA Ph-negative ALL patients treating in first line depending on risk category.Evaluation of survival (event free survival and overall survival) and toxicities in AYA Ph-negative ALL patients treating in first line with argentinian pediatric-like protocol depending on risk category. | Other | Adolescents and young adults Ph-negative ALL patients in first-line |
Primary outcome
Evaluate event free survival of AYA Ph-negative ALL patients treating in first line depending on risk category.
Time frame: 36 months
Evaluate event free survival of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
Evaluate overall survival of AYA Ph-negative ALL patients treating in first line depending on risk category.
Time frame: 36 months
Evaluate overall survival of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
Evaluate toxicities of AYA Ph-negative ALL patients treating in first line depending on risk category.
Time frame: 36 months
Evaluate toxicities of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
3 secondary outcomes
Evaluate survival in patients who underwent allogeneic transplantation in first remission
Time frame: 36 months
Evaluate asparaginase toxicities.
Time frame: 36 months
Assess central cerebrospinal fluid involvement by flow cytometry.
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: Yes. Share study protocol
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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.
Maria Moirano, Dr. principal investigator
Grupo Argentino de Tratamiento de la Leucemia Aguda
Isolda Fernández, Dr. study chair
Grupo Argentino de Tratamiento de la Leucemia Aguda
Luciana Ferrari, Dr. principal investigator
Grupo Argentino de Tratamiento de la Leucemia Aguda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, Adult, run by Grupo Argentino de Tratamiento de la Leucemia Aguda at 2 sites in Argentina.
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 2 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luciana Ferrari, Dr. (541148771000, lferrari@fundaleu.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate event free survival of AYA Ph-negative ALL patients treating in first line depending on risk category. (time frame: 36 months). The study lists 3 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 9 Jan 2024.