Status:
ACTIVE_NOT_RECRUITING
An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
55+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Oral Azacitidine (CC-486) in Chinese participants with acute myeloid leukemia in complete remission.
Eligibility Criteria
Inclusion
- 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 6 months (+/- 7 days) prior to starting study therapy
Exclusion
- 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
Key Trial Info
Start Date :
August 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05413018
Start Date
August 19 2022
End Date
March 1 2026
Last Update
December 8 2025
Active Locations (34)
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1
Local Institution - 0031
Hefei, Anhui, China, 230001
2
Local Institution - 0013
Beijing, BJ, China, 100044
3
Local Institution - 0027
Beijing, BJ, China, 100191
4
Local Institution - 0028
Chongqing, CQ, China, 400000