NCT06565975Completed
Characteristics and Outcomes of Acute Myeloid Leukemia (AML) Patients Treated With Oral-Azacitidine Maintenance Therapy in France
RELION Study: Characteristics and Outcomes of the Patient Population With Acute Myeloid Leukemia in Remission, Treated With Oral Azacitidine Maintenance in France
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 112 (actual)
- First submitted
- 22 Jul 2024
- Start date
- 23 May 2023
- Primary completion date
- 26 Jan 2026
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06565975
What you commit to
- Study type: Observational
- Participants enrolled: 112
- From 23 May 2023 to the primary completion date, 26 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kappa Santé Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.