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APLPhase 2NCT05881265

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

A Phase 2 study testing Chidamide+venetoclax in people with APL, run by Shanghai Jiao Tong University School of Medicine at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 16 to 70 years
Conditions the study is for
APL
What is being tested?
Chidamide+venetoclax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
5 sitesChina
Study dates
15 May 2023to 1 Jan 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chun Wang, M.D., contact

8613386259777

wangchunsh@medmail.com.cn

5 sites in 1 country

China5 sites, 4 recruiting

  • NanFang Hospital

    Guangzhou

    Hongsheng Zhou, 8618665730280, zhs1@i.smu.edu.cn

    Recruiting

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

    Huai'an, Jiangsu

    Liang Yu, 8613405509177, yuliangha@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Wenhua Zhou

    Not yet recruiting

  • Jiong HU

    Shanghai, Shanghai Municipality, 200025

    Jiong HU, M.D.,, 86-21-64370045, hj10709@rjh.com.cn

    Ling Wang, M.D.,, 86-21-64370045, cclingjar@163.com

    Recruiting

  • Zhaxin Hospital, Go Broad Health Care

    Shanghai, Shanghai Municipality

    Active, not recruiting

Other trials in China

About this study

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)

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.

Read the 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.

Conditions
APL
Being tested
Chidamide+venetoclax
Keywords
refractory，APL

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chidamide+venetoclaxDrug

    Also called Chi-VEN

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

Study groups in NCT05881265
Study groupRoleWhat they receive
Chi-Ven treatmentExperimentalPatients receive chidamide and venetoclax treatment
Receives: Drug: Chidamide+venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 42

Secondary outcomes (5)

  1. Overall survival

    Patients alive

    Measured: 1 year

  2. Leukemia-free survival

    Patients alive without leukemia relapse

    Measured: 1 year

  3. Non-relapse mortality

    Patients died without documentation of leukemia relapse

    Measured: 1 year

  4. relapse

    Patients with documentation of leukemia relapse

    Measured: 1 year

  5. Early death

    Patients died of any causes

    Measured: 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2023
  2. Study start15 May 2023
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Chi-Ven treatment
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05881265
Sponsor's protocol ID
R/R-APL-2023
Status last verified
Feb 2025
First submitted
16 May 2023
Last updated
18 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data is available only based on request to study director or principle investigator

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chidamide+venetoclax in people with APL, run by Shanghai Jiao Tong University School of Medicine at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chun Wang, M.D., (8613386259777, wangchunsh@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complete remission and complete remission with incomplete recovery of peripheral blood count (time frame: Day 42). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05881265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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