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)
Shanghai Jiao Tong University School of Medicine
30 participants
May 15, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria3
- Patients with incontrollable infection
- Patients with life-expectancy less than 2 months
- Patients with abnormal liver (\>3XN) and renal function (\>3XN)
Interventions
Chidamide 30mg BIW x 4 weeks; Venetoclax 100mg D1, 200mg D2 and 400mg D3-28
Locations(5)
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NCT05881265