Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients

NCT06544109 | Enrolling By Invitation Phase 2

• 1 other identifier: SZQ002
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• the rate of differential symdrom

  DS, known as retinoic acid syndrome, is a severe complication of ATRA or ATO during the differentiation of promyelocytes. Signs of DS are presented as fever, weight gain, hypertension, dyspnoea, radiographic opacities, peripheral edema and acute renal failure.

  the induction regimen (21 days to 28 days)

Study Arms (1)

Arm Description:the Venatoclax regimen to prevent DS

EXPERIMENTAL

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.

Drug: venetoclax

Interventions

venetoclax DRUG

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

Arm Description:the Venatoclax regimen to prevent DS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

Qiu huiying

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, Acute; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 9, 2024

Record last verified: 2023-08

Locations

CN (1)