Clinical trial · Interventional
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)
NCT05305859CI-TRIAL-00094941recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Refractory Leukemia | Leukemia | CURATED_BROADER | 0.78 |
| Relapsed Adult AML | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| venetoclax combining chidamide and azacitidine (VCA) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- venetoclax combining chidamide and azacitidine (VCA)
- description
- 28 days per cycle × at least 2 cycles; 1\) chidamide 30mg biw × 2weeks;2) venetoclax 200mg/d × 2 weeks 3) azacitidine 100mg/d d1-7
- interventionNames
- Drug: venetoclax combining chidamide and azacitidine (VCA)
Primary outcomes (2)
- measure
- Complete remission (CR) rate
- timeFrame
- 2 months
- description
- CR was \<5% marrow blasts by morphology
- measure
- Overall response rate (ORR)
- timeFrame
- 2 months
- description
- ORR is defined as CR, CRi and PR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.