Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06635681
Phase
PHASE2
Status
Recruiting
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Conditions

  • AML (Acute Myelogenous Leukemia)

Eligibility Criteria

Sex
ALL
Age
14 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Daunorubicin — DRUG
    60mg/m2/d d1-3 in Induction therapy
  • Cytarabine — DRUG
    Cytarabine 100mg/m2/d d1-7 in Induction therapy, 2g/m2 q12h d1-3 in Consolidation therapy
  • Venetoclax — DRUG
    100mg d-2, 200mg d-1, 400mg d1-7 in Induction therapy, 400mg d1-7 in Consolidation therapy and Maintenance treatment
  • Azacitidine — DRUG
    75mg/m2/d d1-5

Study Details

Acute myeloid leukemia (AML) is a common hematological malignancy. Intensive chemotherapy is the main treatment in fit patients. Retrospective studies have shown that Venetoclax is highly effective in elder AML patients with IDH2 and NPM1 mutations while in those with TP53 and FLT3 mutations, the combination of azacitidine with Venetoclax showed an increased remission rate without improved survival. Since AML is a highly heterogeneous disease, it is not clear which genetic type of adult AML patients would benefit from Venetoclax combined with intensive chemotherapy. Therefore, this study intends to conduct a phase II clinical trial to investigate the efficacy of intensive chemotherapy combined with Venetoclax in adult AML patients, and reveal the efficacy of Venetoclax added to chemotherapy regimens for AML with different cytogenetic and molecular subgroups.

Key Dates

Start date
Sep 29, 2024
Status verified
May 2026
Primary completion
Dec 1, 2026
Completion
Oct 1, 2028

Study Design

Enrollment
380 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: venetoclax combined with intensive chemotherapy
    Induction therapy: daunorubicin, cytarabine, combined with venetoclax for 1 course. Consolidation therapy: cytarabine combined with venetoclax for 3 courses. Maintenance therapy: azacitidine combined with venetoclax for 6 courses.

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: up to 2 years after the date of the last enrolled participants ]

Central Contacts

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