Overview

A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission

Status:
Not yet recruiting
Trial end date:
2026-04-22
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the efficacy and safety of oral azacitidine plus best supportive care versus best supportive care as maintenance therapy in a cohort of Japanese participants ≥ 55 years of age with Acute Myeloid Leukemia (AML) and in complete remission/complete remission with incomplete blood count recovery after conventional induction chemotherapy with or without consolidation chemotherapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Azacitidine
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit: www.BMSStudyConnect.com

Inclusion Criteria:

- ≥ 55 years of age inclusive at the time of signing the informed consent

- Newly diagnosed, histologically confirmed de novo Acute Myeloid Leukemia (AML) or AML
secondary to prior myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia
(CMML)

- Should have undergone induction therapy with intensive chemotherapy with or without
consolidation therapy as recommended in appropriate guideline(s) or equivalent regimen
according to institutional standard: having achieved first complete remission
(CR)/complete remission with incomplete blood count recovery (CRi) status within 4
months prior to starting study therapy

Exclusion Criteria:

- Suspected or proven acute promyelocytic leukemia; or AML with previous hematologic
disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding
MDS and CMML

- Prior bone marrow or stem cell transplantation

- Received therapy with hypomethylating agents for MDS and went on to develop AML within
four months of discontinuing the therapy with hypomethylating agents

- Have achieved CR/CRi following therapy with hypomethylating agents

Other protocol-defined inclusion/exclusion criteria apply