Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML

• Status: Not yet recruiting
• Trial end date: 2026-01-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Xiamen University
• Collaborators: Dongguan People's Hospital; Fujian Cancer Hospital; Fujian Provincial Hospital; Huizhou Municipal Central Hospital; Jieyang People's Hospital; Zhangzhou manicipal hospital of Fujian Province
• Treatments: Azacitidine; Venetoclax

Criteria

Inclusion Criteria:

• 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:

1. Creatinine clearance≥30 mL/min and serum Creatinine ≤ 160µmol/L

2. ALT and AST ≤ 3 × upper limit of normal (ULN)

3. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

• Diagnosis of acute promyelocytic leukemia (APL)

• Central nervous system leukemia

• Uncontrolled or significant cardiovascular disease, including any of the following:

1. 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);

2. 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);

3. 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);

4. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;

5. History of New York Heart Association Class 3 or 4 heart failure;

6. Complete left bundle branch block;

7. 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