Combining venetoclax with azacitidine and CAG for treating refractory/relapse acute myeloid leukemia
Phase II Trial of Venetoclax in Combination With Azacitidine and CAG as Induction Therapy in Patients With Refractory/Relapse Acute Myeloid Leukemia
This study is testing a new combination of medications to see if it can help people with hard-to-treat acute myeloid leukemia feel better and achieve remission.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hematology department of the 920th hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Kunming, Yunnan) |
| Trial ID | NCT05807347 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the efficacy and safety of venetoclax in combination with azacitidine and CAG as an induction regimen for patients with refractory or relapsed acute myeloid leukemia (AML). The study is open-label and multicenter, aiming to enroll approximately 42 patients. Previous findings suggest that this combination therapy is well tolerated and may lead to high complete remission rates in similar patient populations. The trial will further investigate these promising results to establish a more effective treatment option for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with refractory or relapsed AML who meet specific health criteria.
Not a fit: Patients with other significant health conditions, uncontrolled infections, or those who have received prior CAG or VA regimens may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with refractory or relapsed acute myeloid leukemia.
How similar studies have performed: Previous studies have shown promising efficacy of venetoclax combined with chemotherapy in de novo AML patients, indicating potential success for this approach in refractory/relapse cases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients ≥ 18 years old and ≤ 65 years old 2. Refractory/Relapse AML patients according to 2016 World Health Organization (WHO) classification; 3. Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3; 4. Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN 5. Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min; Scr (serum creatinine) ≦2 ULN 6. Heart function: left ventricular ejection fraction ≧45% 7. Patients must participate in this clinical trial voluntarily and sign an informed consent form. Exclusion Criteria: 1. Other diseases； 2. AML with central nervous system (CNS) infiltration； 3. Patients have received prior CAG or VA regimen before； 4. Patients with a life expectancy \<3 months 5. Patients with uncontrolled active infection; 6. HIV infection; 7. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. b) An active second cancer that requires treatment within 6 months of study entry 8. Female who are pregnant, breast feeding or childbearing potential. 9. Patients deemed unsuitable for enrollment by the investigator;
Where this trial is running
Kunming, Yunnan
- Department of Hematology,920th Hospital of Joint Logistic Support Force of People's Liberation — Kunming, Yunnan, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.