A Study on the Efficacy and Safety of Venetoclax Combined With HAA Regimen in Newly Diagnosed Young AML.

Sponsor
ZePing Zhou
Study ID
NCT05893472
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • combination of venetoclax and HAA regimen — COMBINATION_PRODUCT
    Using the combination of venetoclax and HAA regimen as induction therapy in young, newly diagnosed adult acute myeloid leukemia patients under the age of 60.

Study Details

The purpose of this study is to investigate the efficacy and safety of the combination of venetoclax and HAA regimen in young, newly diagnosed acute myeloid leukemia patients under the age of 60.

Key Dates

Start date
Apr 1, 2023
Status verified
May 2023
Primary completion
Apr 1, 2024
Completion
Apr 1, 2024

Study Design

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

Arms

  • Experimental: The treatment group receiving the combination of venetoclax and HAA regimen.
    Received induction therapy protocol： Docetaxel (HHT) 2.5mg/㎡/day, days 3-7 Aclarubicin (Acla) 20mg/day, days 3-7 Cytarabine (Ara-c) 100mg/㎡/day, days 3-7 (given as a 24-hour infusion) Venetoclax (VEN): 100mg on day 1, 200mg on day 2, and 400mg on days 3-8.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: up to 12 months ]

Central Contacts

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