Status:
ACTIVE_NOT_RECRUITING
A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
Lead Sponsor:
AbbVie
Collaborating Sponsors:
Roche-Genentech
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be...
Eligibility Criteria
Inclusion
- 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
- History of acute promyelocytic leukemia (APL).
- History of active central nervous system involvement with acute myeloid leukemia (AML).
Key Trial Info
Start Date :
March 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04102020
Start Date
March 26 2020
End Date
June 1 2026
Last Update
August 20 2025
Active Locations (156)
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1
Mitchell Cancer Institute /ID# 216443
Mobile, Alabama, United States, 36604
2
Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156
Fountain Valley, California, United States, 92708-7501
3
University of California, Los Angeles /ID# 219149
Los Angeles, California, United States, 90095
4
Colorado Blood Cancer Institute /ID# 214280
Denver, Colorado, United States, 80218