RecruitingPhase 2NCT05881265

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)

Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

30 participants

Start Date

May 15, 2023

Study Type

INTERVENTIONAL

Conditions

APL

Summary

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.

Eligibility

Min Age: 16 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — chidamide (a type of HDAC inhibitor) and venetoclax (a BCL-2 inhibitor) — in patients with a specific type of leukemia called acute promyelocytic leukemia (APL) that has not gone into remission after standard treatment with retinoic acid and arsenic. Both drugs help trigger cancer cell death through different pathways. **You may be eligible if...** - You have been diagnosed with PML-RARα-positive acute promyelocytic leukemia (APL) - Your leukemia has not achieved remission after treatment with retinoic acid (RA) combined with arsenic - Your life expectancy is at least 3 months - You are able to give informed consent **You may NOT be eligible if...** - You have an active, uncontrolled infection - Your life expectancy is less than 2 months - Your liver or kidney function is significantly impaired (more than 3 times normal levels) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChidamide+venetoclax

Chidamide 30mg BIW x 4 weeks; Venetoclax 100mg D1, 200mg D2 and 400mg D3-28

Locations(5)

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

Jiong HU

Shanghai, Shanghai Municipality, China

Zhaxin Hospital, Go Broad Health Care

Shanghai, Shanghai Municipality, China

NanFang Hospital

Guangzhou, China

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NCT05881265

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