Status:
TERMINATED
Efficacy of Venetoclax Based Regimen in Prevention Relapse of Consecutive MRD Positive AML Patients
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Acute Myeloid Leukemia
Measurable Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Measurable disease (MRD) plays an important role in the therapeutic efficacy and prognosis of acute myeloid leukemia (AML). Studies show that persistent MRD positivity after induction indicates that t...
Detailed Description
In the study, 40 patients will be enrolled and treated with venotoclax combined AZA and DA regimen. Patients receive major response will be given venotoclax combined AZA regimen as maintenance treatme...
Eligibility Criteria
Inclusion
- Diagnosed acute myeloid leukemia
- Received chemotherapy within 24 months and has completed the consolidation treatment plan
- In complete remission
- With MRD positive: abnormal myeloid cells in bone marrow ≥ 0.1%, or NPM1 gene mutation and other fusion gene positive(RUNX 1-RUNX1T 1、CBFB-MYH11 and DEK-NUP214), the PCR quantification ≥1%.
- Age≥ 18 years #male or female
- ECOG-PS score 0-2
- Aboratory tests#within 7 days before chemotherapy# 1). Serum total bilirubin≤1.5xULN# 2). Serum AST and ALT≤2.5xULN 3). Serum creatinine≤2xULN# 4). Cardiac enzymes≤2xULN 5). Ejection fraction \>50% by ECHO#
- Written informed consent
Exclusion
- Hematological relapse (the proportion of blast cells in bone marrow is greater than 5%)
- Receive hematopoietic stem cell transplantation within 4 weeks
- APL
- Have been treated with venetoclax in the past 6 months (who can be enrolled after stopping for more than 6 months)
- Suffering from malignant tumors of other organs (those requiring treatment)
- Pregnant or lactating women
- Active heart diseases
- Severe active infection
- Unfit for enrollment evaluated by investigator
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05361057
Start Date
June 29 2022
End Date
January 23 2024
Last Update
December 5 2025
Active Locations (1)
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1
HBDH
Tianjin, Tianjin Municipality, China, 300020