An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission

• Status: Not yet recruiting
• Trial end date: 2025-12-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of CC-486 in Chinese participants with acute myeloid leukemia in complete remission.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Azacitidine; Cc-486

Criteria

Inclusion Criteria:

• Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML)

• Eastern cooperative oncology group performance status of 0, 1, or 2

• Has undergone induction therapy with intensive chemotherapy with or without consolidation therapy

• Must have achieved first complete remission (CR) or 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 acute myeloid leukemia with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding myelodysplastic syndromes and chronic myelomonocytic leukemia

• Candidate for allogeneic bone marrow or stem cell transplant at screening

• Have achieved CR/CRi following therapy with hypomethylating agents

• AML associated with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) karyotypes or molecular evidence of such translocations

• Proven central nervous system leukemia

• Prior bone marrow or stem cell transplantation

Other protocol-defined inclusion/exclusion criteria apply