Clinical trial · Interventional
Venetoclax Combined With Azacitidine and CAG in 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
NCT05807347CI-TRIAL-00065507unknownPhase 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)
This study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG as induction regimen in Patients with Refreactory/Relapse Acute Myeloid Leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory/Relapse Acute Myeloid Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VACAG（Venetoclax Combined with Azacitidine and CAG）regimen
- description
- Participants will receive induction as azacitidine on days 1-7, venetoclax aily on days 1-28, cytarabine q12h on days 1-7, aclacinomycin on days 1,3,5,7, and granulocyte colony-stimulating factor on days 0-8. Participants will receive second induction if not reach complete remission.
- interventionNames
- Drug: Venetoclax
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- up to 2 cycles from the start of VACAG regimen (each cycle is 28 days)
- description
- The overall remission rate (ORR) was defined as the percentage of patients who achieved complete remission (CR), complete remission with incomplete count recovery (CRi), or morphologic leukemia free state (MLFS) per the International Working Group criteria for AML.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.