Clinical trial · Interventional
Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients
Venetoclax for Prevention of Differentiation Syndrom (DS) in Acute Promyelocytic Leukemia (APL) Patients : An Open-lable, Single-arm, Multicenter, Phase Ⅱ Clinical Trail
NCT06544109CI-TRIAL-00079622Ven APLenrolling by invitationPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to assess the efficacy and safety of venetoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Promyelocytic Leukemia | Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm Description:the Venatoclax regimen to prevent DS
- 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.
- interventionNames
- Drug: venetoclax
Primary outcomes (1)
- measure
- the rate of differential symdrom
- timeFrame
- the induction regimen (21 days to 28 days)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.