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

Primary Purpose

APL

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Chidamide+venetoclax

About this trial

This is an interventional treatment trial for APL focused on measuring refractory，APL

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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）

Sites / Locations

The Affiliated Huai An No 1 Perople's Hospital of NanJing University
The First Affiliated Hospital of Nanchang University
Jiong HURecruiting
Zhaxin Hospital, Go Broad Health Care
NanFang HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chi-Ven treatment

Arm Description

Patients receive chidamide and venetoclax treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival

Patients alive

Leukemia-free survival

Patients alive without leukemia relapse

Non-relapse mortality

Patients died without documentation of leukemia relapse

relapse

Patients with documentation of leukemia relapse

Early death

Patients died of any causes

Full Information

NCT ID

NCT05881265

First Posted

May 16, 2023

Last Updated

October 20, 2023

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai Clinical Research Center

1. Study Identification

Unique Protocol Identification Number

NCT05881265

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 15, 2023 (Actual)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai Clinical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

APL

Keywords

refractory，APL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Chi-Ven treatment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chi-Ven treatment

Arm Type

Experimental

Arm Description

Patients receive chidamide and venetoclax treatment

Intervention Type

Drug

Intervention Name(s)

Chidamide+venetoclax

Other Intervention Name(s)

Chi-VEN

Intervention Description

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

Primary Outcome Measure Information:

Title

complete remission and complete remission with incomplete recovery of peripheral blood count

Description

patients with <5% promyelocytes in bone marrow with or without full recovery of peripheral cell count

Time Frame

Day 42

Secondary Outcome Measure Information:

Title

Overall survival

Description

Patients alive

Time Frame

1 year

Title

Leukemia-free survival

Description

Patients alive without leukemia relapse

Time Frame

1 year

Title

Non-relapse mortality

Description

Patients died without documentation of leukemia relapse

Time Frame

1 year

Title

relapse

Description

Patients with documentation of leukemia relapse

Time Frame

1 year

Title

Early death

Description

Patients died of any causes

Time Frame

42 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chun Wang, M.D.,

Phone

8613386259777

wangchunsh@medmail.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chun Wang

Organizational Affiliation

Zhaxin Hospital, Go Broad Health Care

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Huai'an

State/Province

Jiangsu

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liang Yu

Phone

8613405509177

yuliangha@163.com

Facility Name

The First Affiliated Hospital of Nanchang University

City

Nanchang

State/Province

Jiangxi

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenhua Zhou

Facility Name

Jiong HU

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiong HU, M.D.,

Phone

86-21-64370045

hj10709@rjh.com.cn

First Name & Middle Initial & Last Name & Degree

Ling Wang, M.D.,

Phone

86-21-64370045

cclingjar@163.com

Facility Name

Zhaxin Hospital, Go Broad Health Care

City

Shanghai

State/Province

Shanghai

Country

China

Individual Site Status

Active, not recruiting

Facility Name

NanFang Hospital

City

Guangzhou

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hongsheng Zhou

Phone

8618665730280

zhs1@i.smu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual participant data is available only based on request to study director or principle investigator

Learn more about this trial

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

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