Clinical trial NCT06565975: Characteristics and Outcomes of Acute Myeloid Leukemia (AML) Patients Treated With Oral-Azacitidine Maintenance Therapy in France
Official title: RELION Study: Characteristics and Outcomes of the Patient Population With Acute Myeloid Leukemia in Remission, Treated With Oral Azacitidine Maintenance in France
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Myeloid Leukemia (AML)
Keywords: Acute myeloid leukemia (AML)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-08-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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 maintenance treatment after frontline treatment or second remission for acute myeloid leukemia in France.


Eligibility 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

Primary outcomes:
measure: Participant real-world relapse-free survival (rw-RFS)
timeFrame: Up to date of documented relapse or death assessed up to 41 months
measure: Participant overall survival (OS)
timeFrame: Up to date of documented death assessed up to 41 months
measure: Participant relapsed-free survival (RFS)
timeFrame: From date of achieved complete remission up to 41 months
measure: Participant overall survival (OS) from the time of complete remission achievement
timeFrame: From date of achieved complete remission up to 41 months
measure: Participant relapse rate
timeFrame: 6 and 12 months
measure: Time to treatment discontinuation (TTD)
timeFrame: Up to 41 months
Secondary outcomes:
measure: Participant baseline demographics
timeFrame: Baseline
measure: Type of acute myeloid (AML)
timeFrame: Baseline
measure: Participant cytogenetic abnomalities
timeFrame: Baseline
measure: Participant gene mutation status
timeFrame: Baseline
measure: Participant cytogenetic and mutational risk category
timeFrame: Baseline
measure: Participant acute myeloid (AML) classification as per World Health Organization
timeFrame: Baseline
measure: Participant bone marrow blast percentage
timeFrame: Baseline
measure: Participant hemoglobin levels
timeFrame: Baseline
measure: Participant blood test results
timeFrame: Baseline
measure: Participant Eastern Cooperative Oncology Group or Karnofsky score
timeFrame: Baseline
measure: Participant diagnosis history of other hematological disorders
timeFrame: Baseline
measure: Participant treatment history
timeFrame: Baseline
measure: Minimal residual disease status (MRD)
timeFrame: Baseline
measure: Reason for stem cell transplant ineligibility post initial frontline treatment
timeFrame: Baseline
measure: Participant response type at the initiation of maintenance therapy
timeFrame: Up to 41 months
measure: First versus subsequent remission at the time of initiation of treatment with oral azacitidine
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Oral azacitidine treatment regimen
timeFrame: Up to 41 months
measure: Concomitant support treatment received with oral azacitidine
timeFrame: Up to 41 months
measure: Duration of oral azacitidine treatment
timeFrame: Up to 41 months
measure: Reason for oral azacitidine treatment discontinuation
timeFrame: Up to 41 months
measure: Treatments/procedures following oral azacitidine cessation
timeFrame: Up to 41 months
measure: Participant adverse events (AEs)
timeFrame: Up to 41 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Kappa Sante
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: