Treatment of Chidamide and Venetoclax for Retinoic Acid and Arsenic Resistant Acute Promyelocytic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chidamide+venetoclax.
- Who it may be relevant to
- Registry conditions: APL. Basic parameters: 16 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Interventions
- Drug Chidamide+venetoclax
Chidamide 30mg BIW x 4 weeks; Venetoclax 100mg D1, 200mg D2 and 400mg D3-28
Primary outcome measures
- complete remission and complete remission with incomplete recovery of peripheral blood count [Time frame: Day 42]
Secondary outcome measures (5)
- Overall survival [Time frame: 1 year]
- Leukemia-free survival [Time frame: 1 year]
- Non-relapse mortality [Time frame: 1 year]
- relapse [Time frame: 1 year]
- Early death [Time frame: 42 days]
Eligibility criteria
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）
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 5 centers
- The Affiliated Huai An No 1 Perople's Hospital of NanJing University — Huai'an
- The First Affiliated Hospital of Nanchang University — Nanchang
- Jiong HU — Shanghai
- Zhaxin Hospital, Go Broad Health Care — Shanghai
- NanFang Hospital — Guangzhou
Identifiers
NCT: NCT05881265 · R/R-APL-2023