Status:
RECRUITING
AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Acute Myeloid Leukemia (AML) in Remission
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
PHASE3
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 mye...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT05404906
Start Date
June 25 2022
End Date
June 1 2030
Last Update
August 19 2022
Active Locations (2)
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1
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
2
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China, 215000