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.
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
Patients with incontrollable infection
Patients with life-expectancy less than 2 months
Patients with abnormal liver (>3XN) and renal function (>3XN）
Single group
Chidamide+venetoclax
DrugChidamide 30mg BIW x 4 weeks; Venetoclax 100mg D1, 200mg D2 and 400mg D3-28
complete remission and complete remission with incomplete recovery of peripheral blood count
patients with \<5% promyelocytes in bone marrow with or without full recovery of peripheral cell count
Overall survival
Patients alive
Leukemia-free survival
Patients alive without leukemia relapse
Non-relapse mortality
Patients died without documentation of leukemia relapse
relapse
Patients with documentation of leukemia relapse
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Shanghai Jiao Tong University School of Medicine
Lead sponsor
Shanghai Clinical Research Center
Collaborator
