Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT05805098
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    Starting on day 1, venetoclax will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2 and 400 mg on day 3. The patient then continues to take the 400mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day.
  • Homoharringtonine — DRUG
    On day 1, homoharringtonine 1 mg/m2 IV will be given, and will continue for 5 days.
  • Cytarabine — DRUG
    On day 1, cytarabine 100 mg/m2 IV will be given, and will continue for 5 days.

Study Details

This study aims to evaluate the efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of newly diagnosed acute myeloid leukemia.

Key Dates

Start date
Mar 1, 2023
Status verified
Mar 2023
Primary completion
Mar 1, 2025
Completion
Mar 1, 2028

Study Design

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

Arms

  • Experimental: Venetoclax Combined With Homoharringtonine and Cytarabine
    All recipients in this arm received Venetoclax, Homoharringtonine and Cytarabine. Venetoclax was uesd as 100 mg on day 1, 200 mg on day 2, 400mg from day-3 to day-28. Homoharringtonine was uesd as 1 mg/m2 qd from day-1 to day-5. Cytarabine was uesd as 100 mg/m2 qd from day-1 to day-5.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: 28 days after study treatment ]

Central Contacts

Related Studies