VIALE-M
Brief summary
The main objective of this study is to evaluate safety and efficacy of an active drug in combination with azacitidine (AZA) and best supportive care (BSC) compared to BSC as maintenance therapy in adult participants with acute myeloid leukemia (AML) in first remission after conventional chemotherapy. This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose of an active drug in as maintenance therapy improves RFS comparing to BSC. Part 2 begins after Part 1 is completed. During this study, participants will receive an active drug and azacitidine or best supportive care for approximately 2 years with study visits varying from 1-5 per month.
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
Inclusion Criteria:
- Diagnosis of newly diagnosed acute myeloid leukemia (AML).
- Participant meets the following disease activity criteria:
- Confirmation of AML by World Health Organization (WHO) criteria (2016) and have
confirmed complete remission (CR) or complete remission with incomplete blood
count recovery (CRi) following completion of intensive induction and
consolidation chemotherapies.
- Achieved first CR + CRi within 120 days of first dose of study drug or be no
more than 75 days since last dose of intensive conventional (including both
induction and consolidation) chemotherapies.
- AML has intermediate or poor risk cytogenetics per National Comprehensive
Cancer Network (NCCN) 2016 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
- Participant must have adequate hematologic, renal, and liver function laboratory
values as described in the protocol.
Exclusion Criteria:
- History of acute promyelocytic leukemia (APL).
- History of active central nervous system involvement with acute myeloid leukemia
(AML).
