AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission
Randomized, Multicenter, Phase 3 Study of Azacytidine (AZA) + Venetoclax as Maintenance Therapy in Patients With AML in Remissionin Younger Adults With Favorable-risk AML in First Remission After Conventional Chemotherapy
1 other identifier
interventional
124
1 country
2
Brief Summary
This phase III trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (RFS) for younger adults with favorable-risk acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive consolidation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2022
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2022
CompletedFirst Posted
Study publicly available on registry
June 3, 2022
CompletedStudy Start
First participant enrolled
June 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
August 19, 2022
August 1, 2022
5.9 years
May 31, 2022
August 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Relapse-free survival (RFS)
RFS is defined as the number of days from CR/CRi to the date of relapse or the date of death from any cause, whichever comes first.
From date of complete remission (CR) or complete remission with incomplete count recovery (CRi), to relapse or death from any cause, up to approximately 3 years
Secondary Outcomes (5)
Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) Negative Conversion
Measured From Baseline to approximately 3 years
Complete remission duration (CRd)
From date of CR/CRi to approximately 3 years
Overall Survival (OS)
Time from treatment to death from any cause, up to approximately 3 years
Event free survival (EFS)
Time from treatment to relapse，withdrawal from study due to adverse event and death from any cause, up to approximately 3 years
Incidence of adverse events
Time from treatment to approximately 3 years
Study Arms (2)
Treatment (azacytidine+venetoclax)
EXPERIMENTALParticipants will receive azacytidine QD, on Days 1-5 and venetoclax QD, on Days 1-14 of each 28-day cycle for 8 cycles.
Comparator ( best supportive care)
EXPERIMENTALParticipants will receive observation and supportive care during remission.
Interventions
Patients will receive disease monitoring and supportive care for any complication.
Eligibility Criteria
You may qualify if:
- Diagnosis of favorable-risk acute myeloid leukemia (AML) according to revised 2017 European LeukemiaNet genetic risk stratification and are not immediate candidates for allogeneic stem cell transplant.
- Aged 18-64 years.
- Patients who have received remission induction therapy and 3-4 HiDAC or medium-dose cytarabine-based consolidation and are in their first remission.
- ECOG performance status of \< or = 3.
- Adequate organ function as follows:
- Serum total bilirubin \< or = to 3 X the Upper Limit of Normal (ULN)
- Aspartate Transaminase and alanine transaminase \< or = to 3 x ULN
- Ccr（Creatinine Clearance Rate) \> or ＝60 ml/min
- Left ventricular ejection fraction \> or ＝50% determined by ultrasound.
- For females of childbearing age, they should have a negative serum or urine pregnancy test within 10 to 14 days of enrolling.
- For males of childbearing age, they should take effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment.
- Ability to understand and sign informed consent.
You may not qualify if:
- Acute promyeloid leukemia.
- Patients with active central nervous system (CNS) leukemia.
- Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferative neoplasm(MPN) and progressed to AML.
- Patients with other progressive malignancies.
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled and/or active systemic infection (viral, bacterial or fungal).
- Patients who have participated in other trials within 30 days before signing the informed consent.
- Females who are pregnant or lactating or intending to become pregnant during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, 215000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suning Chen
First Affiliated Hospital of Soochow University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 31, 2022
First Posted
June 3, 2022
Study Start
June 25, 2022
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2030
Last Updated
August 19, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share