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RECRUITINGPhase 2INTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Patients with incontrollable infection - Patients with life-expectancy less than 2 months - Patients with abnormal liver (\>3XN) and renal function (\>3XN) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DRUG

Chidamide+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