Leukemia, Myeloid, AcuteNCT04230564
Acute Myeloid Leukemia Real World Treatment Patterns
An observational study of Leukemia, Myeloid, Acute, run by Pfizer.
Trial summary
Among patients with a diagnosis of AML who received non-intensive chemotherapy: Describe patient demographic and clinical characteristics Describe treatment patterns Describe effectiveness outcomes Evaluate tumor response Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- azacitidine, venetoclax and glasdegib
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2020to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include adult patients diagnosed with AML who, at any point during first line therapy, received non-intensive therapy
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Confirmed diagnosis of AML on or after 01 January 2012 through Clinical Research Nurse (CRN) review of provider documentation of AML diagnosis in the medical record.
- Receipt of non-intensive therapy at any point during first line therapy following initial AML diagnosis. For this study, non-intensive therapy will be defined as 1 of the following agents, alone or in combination with any other agent:
- AZA
- GLAS
- VEN
- Age ≥18 years at initial diagnosis of AML.
Who cannot join
- Patients meeting any of the following criteria will not be included in the study:
- 1. Record of 1 or more of the following confounding diagnoses at any point before or after AML diagnosis: Acute lymphoblastic leukemia; acute promyelocytic leukemia, aggressive systemic mastocytosis; hypereosinophilic syndrome and/or chronic eosinophilic leukemia; dermatofibrosarcoma protuberans; gastrointestinal stromal tumors.
About this study
Official title: Characteristics, Treatment Patterns, and Clinical Outcomes in Non-intensive Chemotherapy Acute Myeloid Leukemia (AML) Patients - a US Real-World Study Using Electronic Medical Record Data
Among patients with a diagnosis of AML who received non-intensive chemotherapy:
- Describe patient demographic and clinical characteristics
- Describe treatment patterns
- Describe effectiveness outcomes
- Evaluate tumor response
- Conditions
- Leukemia, Myeloid, Acute
- Being tested
- azacitidine, venetoclax, glasdegib
- Keywords
- Acute Myeloid Leukemia (AML)
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azacitidineDrug
Patients taking azacitidine
venetoclaxDrug
patients taking venetoclax
glasdegibDrug
patients taking glasdegib
| Study group | Role | What they receive |
|---|---|---|
| AML | Patients diagnosed with AML Receives: Drug: azacitidine; Drug: venetoclax; Drug: glasdegib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival was the duration from diagnosis of disease to death.
Measured: January 1, 2012 to January 10, 2020
Event Free Survival
Time from the treatment initiation date to the date of treatment failure (TF), relapse from CR or better, or death from any cause, whichever comes first
Measured: January 1, 2012 to January 10, 2020
Relapse Free Survival
Time from the treatment initiation date to the date of a relapse event, or death from any cause, whichever comes first
Measured: January 1, 2012 to January 10, 2020
Best response
Best response recorded from treatment start until disease progression/recurrence
Measured: January 1, 2012 to January 10, 2020
Time to best response
Time from treatment initiation until best response recorded
Measured: January 1, 2012 to January 10, 2020
Duration of best response
Time from best response achieved until lose of response or the end of the record, whichever occurs first
Measured: January 1, 2012 to January 10, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start31 Oct 2020 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Why it stopped: Study was cancelled prior to any enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies 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
- 0 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
- NCT04230564
- Sponsor's protocol ID
- B1371038
- Status last verified
- Feb 2021
- First submitted
- 13 Jan 2020
- Last updated
- 7 Jun 2023
- Results posted
- 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 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics, Treatment Patterns, and Clinical Outcomes in Non-intensive Chemotherapy Acute Myeloid Leukemia (AML) Patients - a US Real-World Study Using Electronic Medical Record Data
- ClinicalTrials.gov ID
- NCT04230564
- Acronym / sponsor ID
- B1371038
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- Acute Myeloid Leukemia (AML)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was cancelled prior to any enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2020 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 18 Jan 2020 (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.
Among patients with a diagnosis of AML who received non-intensive chemotherapy:
- Describe patient demographic and clinical characteristics
- Describe treatment patterns
- Describe effectiveness outcomes
- Evaluate tumor response
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AML | – | Drug: azacitidine, Drug: venetoclax, Drug: glasdegibPatients diagnosed with AML |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include adult patients diagnosed with AML who, at any point during first line therapy, received non-intensive therapy
Key inclusion criteria (7 listed)
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Confirmed diagnosis of AML on or after 01 January 2012 through Clinical Research Nurse (CRN) review of provider documentation of AML diagnosis in the medical record.
- Receipt of non-intensive therapy at any point during first line therapy following initial AML diagnosis. For this study, non-intensive therapy will be defined as 1 of the following agents, alone or in combination with any other agent:
- Age ≥18 years at initial diagnosis of AML.
Key exclusion criteria (2 listed)
- 1. Record of 1 or more of the following confounding diagnoses at any point before or after AML diagnosis: Acute lymphoblastic leukemia; acute promyelocytic leukemia, aggressive systemic mastocytosis; hypereosinophilic syndrome and/or chronic eosinophilic leukemia; dermatofibrosarcoma protuberans; gastrointestinal stromal tumors.
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 |
|---|---|---|
| azacitidinePatients taking azacitidine | Drug | AML |
| venetoclaxpatients taking venetoclax | Drug | AML |
| glasdegibpatients taking glasdegib | Drug | AML |
Primary outcome
Overall Survival
Time frame: January 1, 2012 to January 10, 2020
Overall survival was the duration from diagnosis of disease to death.
Event Free Survival
Time frame: January 1, 2012 to January 10, 2020
Time from the treatment initiation date to the date of treatment failure (TF), relapse from CR or better, or death from any cause, whichever comes first
Relapse Free Survival
Time frame: January 1, 2012 to January 10, 2020
Time from the treatment initiation date to the date of a relapse event, or death from any cause, whichever comes first
Best response
Time frame: January 1, 2012 to January 10, 2020
Best response recorded from treatment start until disease progression/recurrence
Time to best response
Time frame: January 1, 2012 to January 10, 2020
Time from treatment initiation until best response recorded
Duration of best response
Time frame: January 1, 2012 to January 10, 2020
Time from best response achieved until lose of response or the end of the record, whichever occurs first
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Myeloid, Acute, run by Pfizer.
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 7 inclusion and 2 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: withdrawn, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Overall Survival (time frame: January 1, 2012 to January 10, 2020). The study lists 6 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 7 Jun 2023.