Status:
RECRUITING
Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Collaborating Sponsors:
Fujian Provincial Hospital
Fujian Cancer Hospital
Conditions:
Leukemia, Myeloid, Acute
Relapsed Adult AML
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
Detailed Description
Patients with relapsed and/or refractory AML have inferior outcomes. The regimen of Venetoclax and Azacitidine has been widely used in the treatment of RR AML and has proved to achieve CR rate of 30% ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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)
- Any other situation where the investigator believes that the patient should not participate in this trial
Key Trial Info
Start Date :
January 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05305859
Start Date
January 12 2022
End Date
June 30 2027
Last Update
September 11 2025
Active Locations (1)
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1
Bing Xu
Xiamen, Fujian, China, 361003