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

NCT05881265 | Recruiting Phase 2 DMC

• 1 other identifier: R/R-APL-2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

APL

Keywords

refractory，APL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall survival

  1 year

• Leukemia-free survival

  1 year

• Non-relapse mortality

  1 year

• relapse

  1 year

• Early death

  42 days

Study Arms (1)

Chi-Ven treatment

EXPERIMENTAL

Patients receive chidamide and venetoclax treatment

Drug: Chidamide+venetoclax

Interventions

Chidamide+venetoclax DRUG

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

Also known as: Chi-VEN

Chi-Ven treatment

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with incontrollable infection
• Patients with life-expectancy less than 2 months
• Patients with abnormal liver (\>3XN) and renal function (\>3XN）

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Clinical Research Center: collaborator

Study Sites (5)

The Affiliated Huai An No 1 Perople's Hospital of NanJing University

Huai'an, Jiangsu, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

Jiong HU

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Zhaxin Hospital, Go Broad Health Care

Shanghai, Shanghai Municipality, China

ACTIVE NOT RECRUITING

NanFang Hospital

Guangzhou, China

RECRUITING

Study Officials

• Chun Wang

  Zhaxin Hospital, Go Broad Health Care

  STUDY DIRECTOR

Central Study Contacts

Chun Wang, M.D.,

CONTACT

8613386259777; wangchunsh@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Blood & Marrow Transplantation Center, Rui Jin Hospital

Model Details: Chi-Ven treatment

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 31, 2023
• Study Start: May 15, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)