Clinical trial · Interventional
Treatment of Chidamide and Venetoclax for Retinoic Acid and Arsenic Resistant Acute Promyelocytic Leukemia
Multi-center Phase II Prospective Study for the Treatment of Chidamide and Venetoclax in Patients With All-trans Retinoic Acid (ATRA) and Arsenic (As) Resistant Acute Promyelocytic Leukemia (APL)
- 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)
Based on the current treatment with retinoic acid (ATRA) and arsenic (As), most patients with APL achieved long-term survival. There are few patients relapsed and became refractory to the RA and As treatment. In our pre-clinical study, we found that targeting histone deacetylase inhibitor 3 (HDAC3)degraded PML-RARa oncoprotein and induced differentiation and apoptosis of RA and As resistant APL in vitro and in vivo. In this study, we evaluate the efficacy and feasibility of combination therapy for HDAC3 inhibitor and venetoclax in patients with refractory APL.
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 |
|---|---|---|---|
| APL | Acute Promyelocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide+venetoclax | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chi-Ven treatment
- description
- Patients receive chidamide and venetoclax treatment
- interventionNames
- Drug: Chidamide+venetoclax
Primary outcomes (1)
- measure
- complete remission and complete remission with incomplete recovery of peripheral blood count
- timeFrame
- Day 42
- description
- patients with \<5% promyelocytes in bone marrow with or without full recovery of peripheral cell count
Secondary outcomes (5)
- measure
- Overall survival
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with PML-RARα+ APL * Patients in non-remission status after treatment of RA combined with As * Patients with life expectance \>=3 months * Inform consent provided Exclusion Criteria: * Patients with incontrollable infection * Patients with life-expectancy less than 2 months * Patients with abnormal liver (\>3XN) and renal function (\>3XN）
References
Publications (0)
Data not yet available