NCT05881265RecruitingPhase 2
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 · Last updated 18 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 16 May 2023
- Start date
- 15 May 2023
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Diseases
- Childhood cancers
- NCT number
- NCT05881265
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 15 May 2023 to the primary completion date, 1 Jan 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with incontrollable infection
Other
- Patients with life-expectancy less than 2 months
- Patients with abnormal liver (\>3XN) and renal function (\>3XN)
Who the study is looking for
- 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
Age in the registry: 16 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Affiliated Huai An No 1 Perople's Hospital of NanJing University Coordinator of this site? Confirm its status | Huai'an | China | Not yet recruiting |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Not yet recruiting |
| Zhaxin Hospital, Go Broad Health Care Coordinator of this site? Confirm its status | Shanghai | China | Active, not recruiting |
| Jiong HU Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.