Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients

NCT ID: NCT06544109

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2028-08-01

Brief Summary

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

Conditions

Acute Promyelocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

venetoclax

Intervention Type: DRUG

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

Interventions

venetoclax

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

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qiu huiying

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

SZQ002

Identifier Type: -

Identifier Source: org_study_id