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Trial Title:
Characteristics and Outcomes of Acute Myeloid Leukemia (AML) Patients Treated With Oral-Azacitidine Maintenance Therapy in France
NCT ID:
NCT06565975
Condition:
Acute Myeloid Leukemia (AML)
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Conditions: Keywords:
Acute myeloid leukemia (AML)
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Oral azacitidine
Description:
As per product label, prescribed by treating physician
Arm group label:
Participants that received maintenance treatment of oral azacitidine
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 maintenance treatment after frontline treatment or second
remission for acute myeloid leukemia in France.
Criteria for eligibility:
Study pop:
Adult patients diagnosed with histologically confirmed de novo acute myeloid leukemia,
therapy-related acute myeloid leukemia, or secondary acute myeloid leukemia who received
maintenance therapy with oral azacitidine while in remission after front-line treatment
or in second remission
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Kappa Sante
Address:
City:
Paris
Zip:
75002
Country:
France
Start date:
May 23, 2023
Completion date:
October 31, 2024
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06565975
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
