APL Clinical Trial
Official title:
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)
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | January 1, 2026 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 70 Years |
Eligibility | Inclusion Criteria: - Patients with PML-RARa+ 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) |
Country | Name | City | State |
---|---|---|---|
China | NanFang Hospital | Guangzhou | |
China | 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 |
China | Zhaxin Hospital, Go Broad Health Care | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Jiao Tong University School of Medicine | Shanghai Clinical Research Center |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Day 42 | |
Secondary | Overall survival | Patients alive | 1 year | |
Secondary | Leukemia-free survival | Patients alive without leukemia relapse | 1 year | |
Secondary | Non-relapse mortality | Patients died without documentation of leukemia relapse | 1 year | |
Secondary | relapse | Patients with documentation of leukemia relapse | 1 year | |
Secondary | Early death | Patients died of any causes | 42 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02020161 -
Clinical Guidelines for APL Treatment
|
Phase 4 |