Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 16 to 70

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.

More APL trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages16 Years to 70 Years
SexAll
Enrollment30 (estimated)
SponsorShanghai Jiao Tong University School of Medicine
Academic / other
Drugs / interventionschemotherapy
Locations5 sites (Huai'an, Jiangsu and 4 other locations)
StatusRecruiting
StartedMay 15, 2023
Main results expectedJanuary 1, 2026
Study endsJanuary 1, 2026
Registry record updatedFebruary 18, 2025
Trial IDNCT05881265 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.