Venetoclax in Combination With Standard Induction and Consolidation Chemotherapy in Newly Diagnosed Young AML Patients

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT06162325
• Lead Sponsor: Peking Union Medical College Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-21
• Status Verified: 2023-12
• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2023-12-01
• Last Update Submitted: 2023-12-01
• Study First Posted: 2023-12-08
• Last Update Posted: 2023-12-08
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	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 Outcome Measures

Name	Time	Method
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.	The rate of patient who get CR after induction therapy.
Rate of minimal residual disease (MRD) negativity	MRD will be tested after every cycle of therapy and during follow-up.	Percentage of patients achieving CR with no evidence of MRD after induction therapy, 1 cycle of consolidation therapy, and 4 cycles of consolidation therapy. MRD negativity is defined as \< 0.1% of CD45 expressing cells with the target immunophenotype, or as cycling threshold (Ct) ≥ 40 in ≥ 2 of 3 replicates by qPCR.
Overall survival (OS)	Assess up to 24 months.	OS is defined as the duration from initiation of induction treatment to the date of death from any cause or last follow-up.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China