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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05881265
Other study ID # R/R-APL-2023
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 15, 2023
Est. completion date January 1, 2026

Study information

Verified date October 2023
Source Shanghai Jiao Tong University School of Medicine
Contact Chun Wang, M.D.,
Phone 8613386259777
Email wangchunsh@medmail.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Chidamide+venetoclax
Chidamide 30mg BIW x 4 weeks; Venetoclax 100mg D1, 200mg D2 and 400mg D3-28

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine Shanghai Clinical Research Center

Country where clinical trial is conducted

China, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT02020161 - Clinical Guidelines for APL Treatment Phase 4