NCT06162325
Enrolling By Invitation
Not Applicable
The Efficacy and Safety of Venetoclax in Combination With Standard Induction and Consolidation Chemotherapy in Newly Diagnosed Young Acute Myeloid Leukemia
Peking Union Medical College Hospital1 site in 1 country45 target enrollmentStarted: January 21, 2022Last updated:
ConditionsAcute Myeloid Leukemia
Overview
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Disease-free survival (DFS)
Overview
Brief Summary
The goal of this observational study is to to evaluate the efficacy and safety of Venetoclax in combination with DA60(daunorubicin 60 mg/m2/d for 3 days, and cytarabine 100 mg/m2 every 12 h for 7 days) induction and HD-AraC(cytarabine 3 g/m2 every 12 h for 3 days) consolidation, in young patients with newly diagnosed acute myeloid leukemia (AML).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Newly diagnosed, morphologically documented AML based on the World Health Organization (WHO) 2016 classification.
- •Age ≥ 18 years and ≤ 59 years
- •Have been treat with the "venetoclax in combination with standard induction and consolidation chemotherapy" therapy, and in follow-up.
- •Be comprehensive of the research, and able to provide informed consent.
Exclusion Criteria
- •Diagnosis of acute promyelocytic leukemia (APL).
- •Prior treatment for AML, except for: leukapheresis, hydroxyurea, and growth factor/cytokine.
- •Unable to understand or participate.
Outcomes
Primary Outcomes
Disease-free survival (DFS)
Time Frame: Assess up to 24 months.
DFS is calculated from the date of remission (inclusive of CR and CRi) to the date of relapse, death from any cause, or last follow-up.
Secondary Outcomes
- Complete remission (CR) rate(On Day 21 (window Day 21 to Day 35), a bone marrow aspirate specimen will be collected for morphology and pathology.)
- Rate of minimal residual disease (MRD) negativity(MRD will be tested after every cycle of therapy and during follow-up.)
- Overall survival (OS)(Assess up to 24 months.)
Investigators
Study Sites (1)
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