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Trial Title:
Treatment of Chidamide and Venetoclax for Retinoic Acid and Arsenic Resistant Acute Promyelocytic Leukemia
NCT ID:
NCT05881265
Condition:
APL
Conditions: Official terms:
Leukemia, Promyelocytic, Acute
Venetoclax
Conditions: Keywords:
refractory，APL
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Chi-Ven treatment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chidamide+venetoclax
Description:
Chidamide 30mg BIW x 4 weeks; Venetoclax 100mg D1, 200mg D2 and 400mg D3-28
Arm group label:
Chi-Ven treatment
Other name:
Chi-VEN
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.
Detailed description:
For patients with newly-diagnosed acute promyelocytic leukemia (APL), the combination
therapy retinoic acid (ATRA) combined with arsenic (As) is the mainstay upfront
treatment. Most patients enjoy long-term survival with or without chemotherapy. Even
though with such good prognosis, there are still some patients relapsed and eventually
became refractory to RA and As treatment. In our pre-clinical study, we demonstrate that
targeting histone deacetylase inhibitor 3 (HDAC3) could degrade PML-RARa oncoprotein and
induce differentiation and apoptosis of RA and As resistant APL in vitro and in vivo. In
this multi-center prospective study, we evaluate the efficacy and feasibility of
combination therapy for HDAC3 inhibitor (chidamide) and venetoclax in patients with
refractory APL.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- Patients with incontrollable infection
- Patients with life-expectancy less than 2 months
- Patients with abnormal liver (>3XN) and renal function (>3XN）
Gender:
All
Minimum age:
16 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Affiliated Huai An No 1 Perople's Hospital of NanJing University
Address:
City:
Huai'an
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Liang Yu
Phone:
8613405509177
Email:
yuliangha@163.com
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wenhua Zhou
Facility:
Name:
Jiong HU
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiong HU, M.D.,
Phone:
86-21-64370045
Email:
hj10709@rjh.com.cn
Contact backup:
Last name:
Ling Wang, M.D.,
Phone:
86-21-64370045
Email:
cclingjar@163.com
Facility:
Name:
Zhaxin Hospital, Go Broad Health Care
Address:
City:
Shanghai
Country:
China
Status:
Active, not recruiting
Facility:
Name:
NanFang Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongsheng Zhou
Phone:
8618665730280
Email:
zhs1@i.smu.edu.cn
Start date:
May 15, 2023
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Shanghai Clinical Research Center
Agency class:
Other
Source:
Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05881265
