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)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
NanFang Hospital
RECRUITING
Guangzhou
The Affiliated Huai An No 1 Perople's Hospital of NanJing University
NOT_YET_RECRUITING
Huai'an
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Jiong HU
RECRUITING
Shanghai
Zhaxin Hospital, Go Broad Health Care
ACTIVE_NOT_RECRUITING
Shanghai
Contact Information
Primary
Chun Wang, M.D.,
wangchunsh@medmail.com.cn
8613386259777
Time Frame
Start Date: 2023-05-15
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 30
Treatments
Experimental: Chi-Ven treatment
Patients receive chidamide and venetoclax treatment
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai Clinical Research Center
Leads: Shanghai Jiao Tong University School of Medicine