Acute Myeloid Leukemia (AML)RELIONNCT06565975
Characteristics and Outcomes of Acute Myeloid Leukemia (AML) Patients Treated With Oral-Azacitidine Maintenance Therapy in France
An observational study of Acute Myeloid Leukemia (AML), run by Bristol-Myers Squibb at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Oral azacitidine
- Type of treatment
- Pill or oral medicine
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2023to 26 Jan 2026
- 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: 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
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RELION Study: Characteristics and Outcomes of the Patient Population With Acute Myeloid Leukemia in Remission, Treated With Oral Azacitidine Maintenance in France
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.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Oral azacitidine
- 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.
Oral azacitidineDrug
As per product label, prescribed by treating physician
| Study group | Role | What they receive |
|---|---|---|
| Participants that received maintenance treatment of oral azacitidine | Not described Receives: Drug: Oral azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant real-world relapse-free survival (rw-RFS)
Measured: Up to date of documented relapse or death assessed up to 41 months
Participant overall survival (OS)
Measured: Up to date of documented death assessed up to 41 months
Participant relapsed-free survival (RFS)
Measured: From date of achieved complete remission up to 41 months
Participant overall survival (OS) from the time of complete remission achievement
Measured: From date of achieved complete remission up to 41 months
Participant relapse rate
Measured: 6 and 12 months
Time to treatment discontinuation (TTD)
Measured: Up to 41 months
Secondary outcomes (23)
Participant baseline demographics
Measured: Baseline
Type of acute myeloid (AML)
AML types include: de novo, or secondary AML (therapy-related AML, or secondary to a myeloid disorder)
Measured: Baseline
Participant cytogenetic abnomalities
Measured: Baseline
Participant gene mutation status
Measured: Baseline
Participant cytogenetic and mutational risk category
Measured: Baseline
Participant acute myeloid (AML) classification as per World Health Organization
Measured: Baseline
Participant bone marrow blast percentage
Measured: Baseline
Participant hemoglobin levels
Measured: Baseline
Participant blood test results
Measured: Baseline
Participant Eastern Cooperative Oncology Group or Karnofsky score
Measured: Baseline
Participant diagnosis history of other hematological disorders
Measured: Baseline
Participant treatment history
Measured: Baseline
Minimal residual disease status (MRD)
Measured: Baseline
Reason for stem cell transplant ineligibility post initial frontline treatment
Measured: Baseline
Participant response type at the initiation of maintenance therapy
Response types include: complete remission (CR), incomplete blood count recovery (Cri) or CR with partial hematology recovery (CRh)
Measured: Up to 41 months
First versus subsequent remission at the time of initiation of treatment with oral azacitidine
Measured: Baseline
Criteria to define complete remission (CR), incomplete blood count recovery (Cri), and CR with partial hematology recovery (CRh) at time of initiation of oral azacitidine
Measured: Baseline
Oral azacitidine treatment regimen
Measured: Up to 41 months
Concomitant support treatment received with oral azacitidine
Measured: Up to 41 months
Duration of oral azacitidine treatment
Measured: Up to 41 months
Reason for oral azacitidine treatment discontinuation
Measured: Up to 41 months
Treatments/procedures following oral azacitidine cessation
Measured: Up to 41 months
Participant adverse events (AEs)
Measured: Up to 41 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start23 May 2023
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565975
- Sponsor's protocol ID
- CA055-1047
- Acronym
- RELION
- Status last verified
- Feb 2026
- First submitted
- 22 Jul 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELION Study: Characteristics and Outcomes of the Patient Population With Acute Myeloid Leukemia in Remission, Treated With Oral Azacitidine Maintenance in France
- ClinicalTrials.gov ID
- NCT06565975
- Acronym / sponsor ID
- RELION / CA055-1047
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Acute myeloid leukemia (AML)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 22 Aug 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants that received maintenance treatment of oral azacitidine | – | Drug: Oral azacitidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Oral azacitidineAs per product label, prescribed by treating physician | Drug | Participants that received maintenance treatment of oral azacitidine |
Primary outcome
Participant real-world relapse-free survival (rw-RFS)
Time frame: Up to date of documented relapse or death assessed up to 41 months
Participant overall survival (OS)
Time frame: Up to date of documented death assessed up to 41 months
Participant relapsed-free survival (RFS)
Time frame: From date of achieved complete remission up to 41 months
Participant overall survival (OS) from the time of complete remission achievement
Time frame: From date of achieved complete remission up to 41 months
Participant relapse rate
Time frame: 6 and 12 months
Time to treatment discontinuation (TTD)
Time frame: Up to 41 months
23 secondary outcomes
Participant baseline demographics
Time frame: Baseline
Type of acute myeloid (AML)
Time frame: Baseline
Participant cytogenetic abnomalities
Time frame: Baseline
Participant gene mutation status
Time frame: Baseline
Participant cytogenetic and mutational risk category
Time frame: Baseline
Participant acute myeloid (AML) classification as per World Health Organization
Time frame: Baseline
Participant bone marrow blast percentage
Time frame: Baseline
Participant hemoglobin levels
Time frame: Baseline
Participant blood test results
Time frame: Baseline
Participant Eastern Cooperative Oncology Group or Karnofsky score
Time frame: Baseline
Participant diagnosis history of other hematological disorders
Time frame: Baseline
Participant treatment history
Time frame: Baseline
Minimal residual disease status (MRD)
Time frame: Baseline
Reason for stem cell transplant ineligibility post initial frontline treatment
Time frame: Baseline
Participant response type at the initiation of maintenance therapy
Time frame: Up to 41 months
First versus subsequent remission at the time of initiation of treatment with oral azacitidine
Time frame: Baseline
Criteria to define complete remission (CR), incomplete blood count recovery (Cri), and CR with partial hematology recovery (CRh) at time of initiation of oral azacitidine
Time frame: Baseline
Oral azacitidine treatment regimen
Time frame: Up to 41 months
Concomitant support treatment received with oral azacitidine
Time frame: Up to 41 months
Duration of oral azacitidine treatment
Time frame: Up to 41 months
Reason for oral azacitidine treatment discontinuation
Time frame: Up to 41 months
Treatments/procedures following oral azacitidine cessation
Time frame: Up to 41 months
Participant adverse events (AEs)
Time frame: Up to 41 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia (AML), run by Bristol-Myers Squibb at 1 site in France.
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 12 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: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participant real-world relapse-free survival (rw-RFS) (time frame: Up to date of documented relapse or death assessed up to 41 months). 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 12 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.