An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission
Status and phase
Active, not recruiting
Phase 2
Conditions
Leukemia, Myeloid, Acute
Treatments
Drug: CC-486
Other: Placebo
Details and patient eligibility
About
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.
Enrollment
34 patients
Sex
All
Ages
55+ years old
Volunteers
No Healthy Volunteers
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 6 months (+/- 7 days) 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
34 participants in 2 patient groups, including a placebo group
CC-486/Oral Azacitidine Administration
Experimental group
Treatment:
Drug: CC-486
Placebo Administration
Placebo Comparator group
Treatment:
Other: Placebo
Trial contacts and locations
34
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Central trial contact
BMS Study Connect Contact Center www.BMSStudyConnect.com; First line of the email MUST contain the NCT# and Site #.
Data sourced from clinicaltrials.gov
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