AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission
NCT ID: NCT05404906
Last Updated: 2022-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
124 participants
INTERVENTIONAL
2022-06-25
2030-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment (azacytidine+venetoclax)
Participants will receive azacytidine QD, on Days 1-5 and venetoclax QD, on Days 1-14 of each 28-day cycle for 8 cycles.
Azacitidine
Given SC
Venetoclax
Given PO
Supportive care
Patients will receive disease monitoring and supportive care for any complication.
Comparator ( best supportive care)
Participants will receive observation and supportive care during remission.
Supportive care
Patients will receive disease monitoring and supportive care for any complication.
Interventions
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Azacitidine
Given SC
Venetoclax
Given PO
Supportive care
Patients will receive disease monitoring and supportive care for any complication.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged 18-64 years.
3. Patients who have received remission induction therapy and 3-4 HiDAC or medium-dose cytarabine-based consolidation and are in their first remission.
4. ECOG performance status of \< or = 3.
5. Adequate organ function as follows:
1. Serum total bilirubin \< or = to 3 X the Upper Limit of Normal (ULN)
2. Aspartate Transaminase and alanine transaminase \< or = to 3 x ULN
3. Ccr（Creatinine Clearance Rate) \> or ＝60 ml/min
4. Left ventricular ejection fraction \> or ＝50% determined by ultrasound.
6. For females of childbearing age, they should have a negative serum or urine pregnancy test within 10 to 14 days of enrolling.
7. For males of childbearing age, they should take effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment.
8. Ability to understand and sign informed consent.
Exclusion Criteria
2. Patients with active central nervous system (CNS) leukemia.
3. Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferative neoplasm(MPN) and progressed to AML.
4. Patients with other progressive malignancies.
5. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled and/or active systemic infection (viral, bacterial or fungal).
6. Patients who have participated in other trials within 30 days before signing the informed consent.
7. Females who are pregnant or lactating or intending to become pregnant during the study.
18 Years
64 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Chen Suning
Principal Investigator
Principal Investigators
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Suning Chen
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Soochow University
Locations
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First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SZ-AML124
Identifier Type: -
Identifier Source: org_study_id
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