Treatment of Chidamide and Venetoclax for Retinoic Acid and Arsenic Resistant Acute Promyelocytic Leukemia

Recruiting now · Phase 2

Conditions studied: APL

In brief

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.

Key facts

Study ID

NCT05881265

Run by

Shanghai Jiao Tong University School of Medicine

People needed

30

Starts

2023-05-15

Expected to finish

2026-01-01

Last updated by the study team

2025-02-18

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients with incontrollable infection
• Patients with life-expectancy less than 2 months
• Patients with abnormal liver (>3XN) and renal function (>3XN）

Where it is running

• Jiong HU — Shanghai, Shanghai Municipality, China (enrolling)
• NanFang Hospital — Guangzhou, China (enrolling)
• The Affiliated Huai An No 1 Perople's Hospital of NanJing University — Huai'an, Jiangsu, China
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
• Zhaxin Hospital, Go Broad Health Care — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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