Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT06544109
Phase
PHASE2/PHASE3
Status
Enrolling By Invitation

Conditions

  • Acute Promyelocytic Leukemia

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • venetoclax — DRUG
    patients in whom the WBC counts increased to more than 2 × 109/L received Venetoclax

Study Details

This study is to assess the efficacy and safety of venetoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.

Key Dates

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

Study Design

Enrollment
98 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Arm Description:the Venatoclax regimen to prevent DS
    The patient with suspected APL should be treated with ATRA or Venetoclx depending on its WBC counts and rapid diagnosis of APL was made at the same time. Once APL was diagnosed, patients were initially treated with ATRA 25 mg/m2/d and ATO 0.16 mg/kg/d. During the induction regimen, patients in whom the WBC counts increased to more than 2 × 109/L received Venetoclax and DS was suspected received dexamethasone or ruxolitinib.

Primary Outcome Measure

the rate of differential symdrom [ Time Frame: the induction regimen (21 days to 28 days) ]

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