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NCT Number: NCT05881265

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

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.

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Key information

Conditions

APL

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Affiliated Huai An No 1 Perople's Hospital of NanJing University, Huai'an, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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）

Treatment and study plan

Chidamide+venetoclax

Drug

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

Other names: Chi-VEN

Primary outcomes

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

    Time frame: Day 42

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

Secondary outcomes

  1. Overall survival

    Time frame: 1 year

    Patients alive

  2. Leukemia-free survival

    Time frame: 1 year

    Patients alive without leukemia relapse

  3. Non-relapse mortality

    Time frame: 1 year

    Patients died without documentation of leukemia relapse

  4. relapse

    Time frame: 1 year

    Patients with documentation of leukemia relapse

  5. Early death

    Time frame: 42 days

    Patients died of any causes

Study contacts

Contact information is provided by the study sponsor or research team.

Chun Wang, M.D.,

CONTACT

[email protected]

8613386259777

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Shanghai Clinical Research Center

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 31, 2023
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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