Combining Chidamide and Venetoclax for Hard-to-Treat Acute Promyelocytic Leukemia
Official title: 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)
Run by Shanghai Jiao Tong University School of Medicine · NCT05881265 · Data updated 2026-11-12
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 |
| Ages | 16 Years to 70 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Huai'an, Jiangsu and 4 other locations) |
| Status | Recruiting |
| Started | May 15, 2023 |
| Main results expected | January 1, 2026 |
| Study ends | January 1, 2026 |
| Registry record updated | February 18, 2025 |
| Trial ID | NCT05881265 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with PML-RARα+ APL who are not in remission after treatment with retinoic acid and arsenic.
✕Probably not a fit
Patients with uncontrollable infections or severely impaired liver and renal function may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is based on promising pre-clinical results, it represents a novel strategy that has not been extensively tested in clinical settings.
Who can join: the full rules
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 it's running
-
Jiong HU
Shanghai, Shanghai Municipality, China Recruiting -
NanFang Hospital
Guangzhou, China Recruiting -
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 -
Zhaxin Hospital, Go Broad Health Care
Shanghai, Shanghai Municipality, China Active not recruiting
Study contacts
- Study coordinator: Chun Wang, M.D.,
- Email: wangchunsh@medmail.com.cn
- Phone: 8613386259777
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Early use of oral Realgar-Indigo Naturalis plus all-trans retinoic acid for acute promyelocytic leukemia
This study will test whether starting an oral arsenic medicine called Realgar-Indigo Naturalis Formula (RIF) together with all-trans retinoic acid (ATRA) early in treatment can lower early deaths in adults with acute promyelocytic leukemia (APL).
-
QTX-2101 (oral arsenic) plus ATRA for adults with low- or intermediate-risk APL
This Phase 3 trial tests whether an oral arsenic capsule (QTX-2101) combined with ATRA works well and is safe for adults aged 18–70 with newly diagnosed low- or intermediate-risk acute promyelocytic leukemia.
-
Combining oral arsenic and ATRA for treating newly diagnosed acute promyelocytic leukemia
This study is testing if a new treatment combining oral arsenic and ATRA can help newly diagnosed patients with acute promyelocytic leukemia live longer and feel better, especially those at high risk.
-
Using sirolimus to treat thrombocytopenia related to antiphospholipid antibodies
This study is testing if the medication sirolimus can help people with low platelet counts caused by antiphospholipid antibodies feel better compared to those who receive a placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.