Clinical trial · Interventional
Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients
A Single-center, Single-arm, Prospective Clinical Study on the Efficacy and Safety of Venetoclax and Azacitidine Combined With HAAG in the Induction Treatment of Intermediate and High-risk Acute Myeloid Leukemia
NCT06394011CI-TRIAL-00076628recruitingPhase 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 efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Risk Acute Myeloid Leukemia | — | UNRESOLVED | — |
| Intermediate Risk Acute Myeloid Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| venetoclax, azacitidine and HAAG regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VA combined with HAAG
- description
- This cohort will determine the safety and efficacy of venetoclax, azacitidine combined with HAAG regimen in newly diagnosed intermediate and high-risk AML patients.
- interventionNames
- Drug: venetoclax, azacitidine and HAAG regimen
Primary outcomes (1)
- measure
- Composite complete response rate (CRc; CR+CRi)
- timeFrame
- Day 28-35 of induction course
- description
- CRc includes complete response CR and CRi; CR was defined as \< 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as\<5% bone marrow blasts, either ANC\<1×10\^9/L or platelets\<100×10\^9/L, transfusion independence but with persistence of cytopenia.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL). 2. Age 18-65. 3. ECOG score: 0-2. 4. No history of previous chemotherapy or target therapy. 5. Serum total bilirubin \<= 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) \<= 1.5 times ULN, aspartate aminotransferase (AST) \<=1.5 times ULN; 6. Creatinine clearance rate \>=30 mL/min; 7. Serum lipase \<= 1.5 times ULN, amylase \<= 1.5 times ULN; 8. Capable to understand and willing to participate in this study, signed the informed consent form. Exclusion Criteria: 1. AML transformed with chronic myelogenous leukemia. 2. Acute promyelocytic leukemia (type M3). 3. Patients with a second malignancy requiring treatment. 4. Patients with uncontrolled active infection. 5. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification. 6. Patients with hepatic and renal inadequacy: total serum bilirubin \>=2.0 mg/dl, AST \>=3 times ULN, serum creatinine clearance (Ccr) \<50 ml / min. 7. Patients with arterial oxygen saturation (SpO 2) was \<95%. 8. Patients with HIV infection. 9. Patients with active hepatitis B or hepatitis C infection. 10. Patients with other commodities that the investigators considered not suitable for the enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.