Status:
ACTIVE_NOT_RECRUITING
Characteristics and Outcomes of Acute Myeloid Leukemia (AML) Patients Treated With Oral-Azacitidine Maintenance Therapy in France
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of oral azacitidine prescribed as maintena...
Eligibility Criteria
Inclusion
- Participants who initiated oral azacitidine maintenance therapy during early access program (EAP) in France (January 29, 2021 to July 13, 2022) or during the 6 months post-EAP (from July 14, 2022, to January 2014, 2023) inside the marketing authorization label "adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT)."
- Participants with histologically confirmed diagnosis of de novo AML, or therapy-related AML, or secondary AML
- Participants who received frontline treatment after diagnosis of AML and achieved complete remission (CR), CR with incomplete blood count recovery (Cri), or CR with partial hematology recovery (CRh) after one or subsequent lines of therapy in case of relapse
- Participant is at least 18 years of age at the time of initial diagnosis of AML
- Participants alive or deceased at the time of data collection
- Physician has access to the complete medical record for the patient, including any transferred records from other facilities (if applicable); patient's medical record must at least include the following:
- Date of diagnosis of AML
- Frontline therapy(ies) received, and treatment start dates
- Date(s) of first documented evidence of response
- Oral azacitidine start and (if applicable) stop date
- Documentation (yes/no) of relapse on oral azacitidine, where applicable
- Participants who do not object to the data collection
Exclusion
- Participants who initiated maintenance with oral azacitidine after January 14, 2023
- Participant who initiated maintenance with oral azacitidine before January 14, 2023, outside of the marketing authorization label
Key Trial Info
Start Date :
May 23 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06565975
Start Date
May 23 2023
End Date
October 31 2024
Last Update
August 22 2024
Active Locations (1)
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1
Kappa Sante
Paris, France, 75002