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

NCT ID: NCT05881265

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2026-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

APL

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Chi-Ven treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chi-Ven treatment

Patients receive chidamide and venetoclax treatment

Group Type EXPERIMENTAL

Chidamide+venetoclax

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Chidamide+venetoclax

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Chi-VEN

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Clinical Research Center

UNKNOWN

Sponsor Role collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jiong HU

Head, Blood & Marrow Transplantation Center, Rui Jin Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chun Wang

Role: STUDY_DIRECTOR

Zhaxin Hospital, Go Broad Health Care

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Huai'an, Jiangsu, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status NOT_YET_RECRUITING

Jiong HU

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Zhaxin Hospital, Go Broad Health Care

Shanghai, Shanghai Municipality, China

Site Status ACTIVE_NOT_RECRUITING

NanFang Hospital

Guangzhou, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chun Wang, M.D.,

Role: CONTACT

8613386259777

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Liang Yu

Role: primary

8613405509177

Wenhua Zhou

Role: primary

Jiong HU, M.D.,

Role: primary

86-21-64370045

Ling Wang, M.D.,

Role: backup

86-21-64370045

Hongsheng Zhou

Role: primary

8618665730280

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R/R-APL-2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.