Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Myeloid Leukemia (AML)

Keywords

Acute myeloid leukemia (AML)

Outcome Measures

Primary Outcomes (6)

Participant real-world relapse-free survival (rw-RFS)
Up to date of documented relapse or death assessed up to 41 months
Participant overall survival (OS)
Up to date of documented death assessed up to 41 months
Participant relapsed-free survival (RFS)
From date of achieved complete remission up to 41 months
Participant overall survival (OS) from the time of complete remission achievement
From date of achieved complete remission up to 41 months
Participant relapse rate
6 and 12 months
Time to treatment discontinuation (TTD)
Up to 41 months

Secondary Outcomes (23)

Participant baseline demographics
Baseline
Type of acute myeloid (AML)
Baseline
Participant cytogenetic abnomalities
Baseline
Participant gene mutation status
Baseline
Participant cytogenetic and mutational risk category
Baseline
+18 more secondary outcomes

Study Arms (1)

Participants that received maintenance treatment of oral azacitidine

Drug: Oral azacitidine

Interventions

Oral azacitidineDrug

As per product label, prescribed by treating physician

Participants that received maintenance treatment of oral azacitidine

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

You may qualify if:

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)."

Sponsors & Collaborators

Bristol-Myers Squibb
Industrylead

Study Sites (1)

Kappa Sante

Paris, 75002, France

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidines

Study Officials

Bristol-Myers Squibb
Bristol-Myers Squibb
STUDY DIRECTOR

Enrollment

112 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 22, 2024

First Posted

August 22, 2024

Study Start

May 23, 2023

Actual (reported)

Characteristics and Outcomes of Acute Myeloid Leukemia (AML) Patients Treated With Oral-Azacitidine Maintenance Therapy in France

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (23)

Study Arms (1)

Participants that received maintenance treatment of oral azacitidine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (23)

Study Arms (1)

Participants that received maintenance treatment of oral azacitidine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations