Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML
A Multi-center, Prospective, Single-arm Study of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of Refractory/Relapsed Acute Myelogenous Leukemia (R/R AML)
2 other identifiers
interventional
30
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of relapsed and/or refractory AML
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2022
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2022
CompletedFirst Submitted
Initial submission to the registry
March 8, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
ExpectedSeptember 11, 2025
September 1, 2025
4.1 years
March 8, 2022
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Complete remission (CR) rate
CR was \<5% marrow blasts by morphology
2 months
Overall response rate (ORR)
ORR is defined as CR, CRi and PR.
2 months
Secondary Outcomes (3)
1 year leukemia free survival (LFS)
1 year from treatment initiation
1year overall survival (OS)
1 year from treatment initiation
Adverse events
2 months
Study Arms (1)
venetoclax combining chidamide and azacitidine (VCA)
EXPERIMENTAL28 days per cycle × at least 2 cycles； 1\) chidamide 30mg biw × 2weeks；2) venetoclax 200mg/d × 2 weeks 3) azacitidine 100mg/d d1-7
Interventions
information already included in arm/group descriptions
Eligibility Criteria
You may qualify if:
- Age ≥18
- Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology
- ECOG：0-2
- Life expectancy ≥ 3 months
- Adequate laboratory parameters during the screening period as evidenced by the following:
- Creatinine clearance≥30 mL/min and serum Creatinine ≤ 160µmol/L
- ALT and AST ≤ 3 × upper limit of normal (ULN)
- Able to understand and sign an informed consent form (ICF).
You may not qualify if:
- Diagnosis of acute promyelocytic leukemia (APL)
- Central nervous system leukemia
- Uncontrolled or significant cardiovascular disease, including any of the following:
- Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker; Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
- Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg; History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
- History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
- History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;
- History of New York Heart Association Class 3 or 4 heart failure;
- Complete left bundle branch block;
- Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal;
- Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
- Suffered from other non-myeloid malignancies within 2 years, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease
- Females who are pregnant or breastfeeding;
- Mental disorders that hinder research participation
- Previous solid organ transplantation (SCT treatment is allowed in advance, but if the patient has GVHD or is still receiving immunosuppression/GVHD treatment, it is not allowed)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The First Affiliated Hospital of Xiamen Universitylead
- Fujian Provincial Hospitalcollaborator
- Fujian Cancer Hospitalcollaborator
- Zhangzhou manicipal hospital of Fujian Provincecollaborator
- Jieyang People's Hospitalcollaborator
- Dongguan People's Hospitalcollaborator
- Huizhou Municipal Central Hospitalcollaborator
Study Sites (1)
Bing Xu
Xiamen, Fujian, 361003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bing Xu
The First Affiliated Hospital of Xiamen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2022
First Posted
March 31, 2022
Study Start
January 12, 2022
Primary Completion
January 31, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share