Combining Chidamide and Venetoclax for Hard-to-Treat 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)
This study is testing a new combination of two drugs, chidamide and venetoclax, to see if it can help people with hard-to-treat acute promyelocytic leukemia who haven't responded to standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 16 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Huai'an, Jiangsu and 4 other locations) |
| Trial ID | NCT05881265 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a combination therapy using chidamide, a histone deacetylase inhibitor, and venetoclax in patients with acute promyelocytic leukemia (APL) who have become resistant to standard treatments with retinoic acid and arsenic. The study aims to assess how well this new approach can induce differentiation and apoptosis in resistant APL cells. It is a multi-center prospective study that builds on promising pre-clinical findings indicating that targeting HDAC3 can degrade the oncoprotein responsible for the disease. Participants will be monitored for treatment efficacy and feasibility.
Who should consider this trial
Good fit: Ideal candidates include patients with PML-RARα+ APL who are not in remission after treatment with retinoic acid and arsenic.
Not a fit: Patients with uncontrollable infections or severely impaired liver and renal function may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with refractory APL, potentially improving their survival and quality of life.
How similar studies have performed: While this approach is based on promising pre-clinical results, it represents a novel strategy that has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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）
Where this trial is running
Huai'an, Jiangsu and 4 other locations
- The Affiliated Huai An No 1 Perople's Hospital of NanJing University — Huai'an, Jiangsu, China (Not_yet_recruiting)
- The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
- Jiong HU — Shanghai, Shanghai Municipality, China (Recruiting)
- Zhaxin Hospital, Go Broad Health Care — Shanghai, Shanghai Municipality, China (Active_not_recruiting)
- NanFang Hospital — Guangzhou, China (Recruiting)
Study contacts
- Study coordinator: Chun Wang, M.D.,
- Email: wangchunsh@medmail.com.cn
- Phone: 8613386259777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.