NCT05305859 Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML
| NCT ID | NCT05305859 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Xiamen University |
| Condition | Leukemia, Myeloid, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-01-12 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2022-01-12 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Bing Xu
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of Xiamen University
Frequently Asked Questions
Who can join the NCT05305859 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Leukemia, Myeloid, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05305859 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05305859 currently recruiting?
Yes, NCT05305859 is actively recruiting participants. Contact the research team at xubingzhangjian@126.com for enrollment information.
Where is the NCT05305859 trial being conducted?
This trial is being conducted at Xiamen, China.
Who is sponsoring the NCT05305859 clinical trial?
NCT05305859 is sponsored by The First Affiliated Hospital of Xiamen University. The principal investigator is Bing Xu at The First Affiliated Hospital of Xiamen University. The trial plans to enroll 30 participants.
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