Clinical trial · Interventional
Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients
A Multicenter, Randomized, Controlled Clinical Trial Comparing VA and D/IA Induction Regimens in Elderly Patients With Acute Myeloid Leukemia Suitable for Intensive Chemotherapy
NCT07132684CI-TRIAL-00104350recruitingPhase 3ClinicalTrials.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 is a multicenter, randomized, controlled phase III clinical trial aimed at comparing the efficacy of two induction chemotherapy regimens-VA (Venetoclax + Azacitidine) and D/IA (Daunorubicin/Idarubicin + Cytarabine)-in elderly patients (aged 55-75) with acute myeloid leukemia (AML) who are fit for intensive chemotherapy.
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 |
|---|---|---|---|
| AML, Adult | Adult Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Daunorubicin/Idarubicin | Drug | — | UNRESOLVED |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- D/IA (Daunorubicin/Idarubicin + Cytarabine)
- description
- Induction Cycle 1: * Cytarabine: 100 mg/m²/day, days 1-7 * Daunorubicin: 60 mg/m²/day, days 1-3 or * Idarubicin: 12 mg/m²/day, days 1-3 • Induction Cycle 2 (if CR/CRi/CRh not achieved after Cycle 1): * Cyclophosphamide: 350 mg/m²/day, days 2 and 5o Cytarabine: 100 mg/m²/day, days 1-7 * Daunorubicin: 45 mg/m²/day, days 1-2 or * Idarubicin: 8 mg/m²/day, days 1-2 Consolidation Therapy • Intermediate-Dose Cytarabine (ID-Ara-C): 2 cycles Maintenance Therapy * Low/Intermediate-Risk Patients: 1. DA/IA "2+5" Regimen, 2 cycles Cytarabine: 100 mg/m²/day, days 1-5 Daunorubicin: 30 mg/m²/day, days 1-2 or Idarubicin: 8 mg/m²/day, days 1-2 2. VA Regimen, 4 cycles Azacitidine: 75 mg/m²/day, days 1-5 Venetoclax: 400 mg/day, days 1-7, oral * High-Risk Patients: VA Regimen, 6 cycles Allogeneic Transplantation: Recommended for high-risk patients and those with persistent MRD positivity.
- interventionNames
- Drug: Daunorubicin/Idarubicin
- Drug: Cytarabine
- Drug: Azacitidine
- Drug: Venetoclax
- type
- EXPERIMENTAL
- label
- VA Regimen
- description
- Induction Cycles * Azacitidine: 75 mg/m²/day, days 1-7 * Venetoclax: Day 1: 100 mg Day 2: 200 mg Days 3-21: 400 mg/day If bone marrow blasts \>5% on day 21, extend to day 28 with 400 mg/day • Efficacy will be assessed after 2 cycles. If CR/CRi/CRh is not achieved but the investigator believes continued treatment is beneficial, up to 4 cycles may be administered. Consolidation Therapy • Intermediate-Dose Cytarabine (ID-Ara-C): 2 cycles Maintenance Therapy * Low/Intermediate-Risk Patients: 1: DA/IA "2+5" Regimen, 2 cycles Cytarabine: 100 mg/m²/day, days 1-5 Daunorubicin: 30 mg/m²/day, days 1-2 or Idarubicin: 8 mg/m²/day, days 1-2 2.VA Regimen, 4 cycles Azacitidine: 75 mg/m²/day, days 1-5 Venetoclax: 400 mg/day, days 1-7, oral * High-Risk Patients: * VA Regimen, 6 cycles Allogeneic Transplantation: Recommended for high-risk patients and those with persistent MRD positivity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of AML according to WHO (2022) or ICC criteria. * Age ≥55 and ≤75 years. * ECOG performance status score of 0-2. * Adequate organ function: * Total bilirubin ≤1.5× upper limit of normal (ULN) * AST and ALT ≤2.5× ULN * Serum creatinine \<2× ULN * Cardiac enzymes \<2× ULN * Left ventricular ejection fraction (LVEF, by echocardiogram) within normal range Signed informed consent by the patient or legal representative. Exclusion Criteria: * Acute promyelocytic leukemia with PML-RARA fusion gene. * AML with RUNX1-RUNX1T1 or CBFB-MYH11 fusion genes. * AML with BCR-ABL fusion gene. * Relapsed or refractory AML (previously treated with induction chemotherapy, but hydroxyurea is allowed). * Concurrent other malignancies requiring treatment. * Active cardiac disease (e.g., uncontrolled angina, recent myocardial infarction, severe arrhythmias, uncontrolled heart failure, LVEF below normal). * Severe infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis). * Other conditions deemed unsuitable by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.