Combining Venetoclax, Chidamide, and Azacitidine for treating relapsed 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)

This study is testing a new combination of three drugs to see if it can help people with relapsed acute myeloid leukemia feel better and achieve longer-lasting results.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Xiamen University (other)
• Locations: 1 site (Xiamen, Fujian)
• Trial ID: NCT05305859 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a combination treatment involving Venetoclax, Chidamide, and Azacitidine for patients with relapsed or refractory acute myeloid leukemia (AML). The study builds on previous findings that show Venetoclax and Azacitidine can achieve a complete response rate of 30-40%, but with a limited duration of response. By adding Chidamide, a histone deacetylase inhibitor, researchers aim to enhance the treatment's effectiveness. The trial will monitor patient responses and tolerability to this new regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory acute myeloid leukemia.

Not a fit: Patients with acute promyelocytic leukemia or significant cardiovascular issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with relapsed or refractory AML.

How similar studies have performed: Previous studies have shown promising results with similar combinations, but this specific regimen is novel.

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

Where this trial is running

Xiamen, Fujian

• Bing Xu — Xiamen, Fujian, China (RECRUITING)

Study contacts

• Principal investigator: Bing Xu — The First Affiliated Hospital of Xiamen University
• Study coordinator: Bing Xu, M.D.

Conditions: Leukemia, Myeloid, Acute, Relapsed Adult AML, Refractory Leukemia, refractory/relapsed acute myelogenous leukemia