Actively Recruiting
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)
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-09-11
30
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Xiamen University
Lead Sponsor
F
Fujian Provincial Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combined treatment called Venetoclax with Chidamide and Azacitidine (VCA) for adults with relapsed or refractory acute myeloid leukemia (AML), a condition where the disease has returned or does not respond to previous treatments. This Phase 2 study aims to improve outcomes for these patients, as current treatments show limited duration of response. The study is sponsored by The First Affiliated Hospital of Xiamen University and builds on early data suggesting potential benefits of adding Chidamide to standard therapy. The treatment involves cycles lasting 28 days, with patients receiving Chidamide 30 mg twice a week for two weeks, Venetoclax 200 mg daily for two weeks, and Azacitidine 100 mg daily for seven days each cycle. Participants are expected to complete at least two cycles of this regimen. The regimen is given orally and by injection under medical supervision, and the study is designed as a single-arm trial without a comparison group. Participants will be closely monitored through regular assessments including blood tests and clinical evaluations to track response to treatment and side effects. The main outcomes measured are the rates of complete remission and overall response after two months. Secondary outcomes include survival without leukemia for one year, overall survival at one year, and recording any adverse events during the first two months. The total participation time depends on treatment response and safety follow-up until June 2027.
CONDITIONS
Brief Title
Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with relapsed or refractory acute myeloid leukemia by morphology and immunology
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 3 months
- Adequate kidney function with creatinine clearance of 30 mL/min or more and serum creatinine 160 µmol/L or less
- Liver function with ALT and AST levels at or below 3 times the upper limit of normal
- Able to understand and sign an informed consent form
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL)
- Presence of central nervous system leukemia
- Significant or uncontrolled cardiovascular disease, including slow heart rate below 50 beats per minute without pacemaker, long QT syndrome, very high blood pressure, serious arrhythmias, recent heart attack, severe heart failure, complete left bundle branch block, or low left ventricular ejection fraction (45% or less)
- Active uncontrolled infections not well managed by treatment
- History of non-myeloid cancers within 2 years except certain treated skin or in-situ cancers
- Pregnant or breastfeeding females
- Mental disorders that prevent participation in the study
- Previous solid organ transplantation with ongoing graft-versus-host disease or immunosuppression
- Any other condition deemed by the investigator to prevent safe participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days per cycle × at least 2 cycles
Participants receive the drug regimen of venetoclax combining chidamide and azacitidine (VCA) in cycles to treat relapsed or refractory acute myeloid leukemia.
Visits occur throughout each 28-day treatment cycle
Trial Site Locations
Total: 1 location
1
Bing Xu
Xiamen, Fujian, China, 361003
Actively Recruiting
Research Team
B
Bing Xu, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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