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

Acute Myeloid Leukemia Clinical Trial

Official title:

The Efficacy and Safety of Venetoclax in Combination With Standard Induction and Consolidation Chemotherapy in Newly Diagnosed Young Acute Myeloid Leukemia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06162325
• Other study ID #: AML-VEN PLUS
• Status: Enrolling by invitation
• Start date: January 21, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS)	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.	Assess up to 24 months.
Secondary	Complete remission (CR) rate	The rate of patient who get CR after induction therapy.	On Day 21 (window Day 21 to Day 35), a bone marrow aspirate specimen will be collected for morphology and pathology.
Secondary	Rate of minimal residual disease (MRD) negativity	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.	MRD will be tested after every cycle of therapy and during follow-up.
Secondary	Overall survival (OS)	OS is defined as the duration from initiation of induction treatment to the date of death from any cause or last follow-up.	Assess up to 24 months.