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

ConditionAPL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-70
SponsorShanghai Jiao Tong University School of Medicine

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Patients with incontrollable infection

Patients with life-expectancy less than 2 months

Patients with abnormal liver (>3XN) and renal function (>3XN)

Trial design

Treatments tested in this trial

  • Chidamide+venetoclax

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Shanghai Clinical Research Center

Collaborator