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Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients (Ven APL)

S

Soochow University

Status and phase

Invitation-only
Phase 3
Phase 2

Conditions

Acute Promyelocytic Leukemia

Treatments

Drug: venetoclax

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

98 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
  2. patients must have confirmation of APL by WHO criteria, previously untreated, and eligible for treatment with intensive chemotherapy as defined by the following: Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%. Creatinine clearance < 45 mL/min. Moderate hepatic impairment with total bilirubin > 1.5 × ULN. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.

Exclusion criteria

  1. Patient is ineligible for treatment with intensive chemotherapy
  2. Patient with active infection not controlled, active bleeding from vital organs
  3. Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

98 participants in 1 patient group

Arm Description:the Venatoclax regimen to prevent DS
Experimental group
Description:
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.
Treatment:
Drug: venetoclax

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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