Clinical trial · Interventional
A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients
Venetoclax/Azacitidine/Low-Dose Cytarabine/Aclarubicin/G-CSF (VA-CAG) in Newly-Diagnosed Acute Myeloid Leukemia: A Phase-2, Multi-center, Prospective Clinical Study
NCT05662956CI-TRIAL-00092131completedPhase 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(VA-CAG) as induction regimen in newly diagnosed young patients with acute myeloid leukemia(AML).
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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Venetoclax in combination with azacitidine and CAG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- Induction: Subjects who meet the enrollment conditions will receive Venetoclax plus Azacitidine and CAG(VA-CAG) . Participants will receive this induction Therapy 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. Consolidation: If patients are intermediate or poor risk and have plans for allogeneic hematopoietic stem-cell transplantation(allo-HSCT) , high dose cytarabine (3g/m2 q12h days 1-3) for 1-2 cycles and follow up with allo-HSCT. In other cases, high dose cytarabine for 4 cycles.
- interventionNames
- Drug: Venetoclax in combination with azacitidine and CAG
Primary outcomes (1)
- measure
- CR rate
- timeFrame
- At the end of Cycle 1 of induction (each cycle is about 30 days)
Secondary outcomes (3)
- measure
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. Newly diagnosed as AML patients according to 2016 World Health Organization (WHO) classification; 3. Patients without receiving prior therapy for AML; 4. Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3; 5. Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN 6. Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min; Scr (serum creatinine) ≦2 ULN 7. Heart function: left ventricular ejection fraction ≧45% 8. Patients must participate in this clinical trial voluntarily and sign an informed consent form. Exclusion Criteria: 1. Acute promyeloid leukemia； 2. AML with central nervous system (CNS) infiltration； 3. Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML； 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.