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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
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

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nanfang Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
The Affiliated Huai An No 1 Perople's Hospital of NanJing University
Coordinator of this site? Confirm its status
Huai'anChinaNot yet recruiting
The First Affiliated Hospital of NanChang University
Coordinator of this site? Confirm its status
NanchangChinaNot yet recruiting
Zhaxin Hospital, Go Broad Health Care
Coordinator of this site? Confirm its status
ShanghaiChinaActive, not recruiting
Jiong HU
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.