Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients

NCT07132684 | Recruiting Phase 3

• 1 other identifier: IIT2025095
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

AML, Adult

Keywords

acute myeloid leukemia; Older fit patients; venetoclax

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Time from randomization to death from any cause.

  up to 1 years after completion of enrollment

Secondary Outcomes (5)

• Composite Complete Remission Rate (CR/CRh/CRi)

  Six weeks after induction therapy

• MRD Negativity Rate

  up to 1 years after completion of enrollment

• Relapse-Free Survival (RFS)

  up to 1 years after completion of enrollment

• Event-Free Survival (EFS)

  up to 1 years after completion of enrollment

• 30-Day and 60-Day Mortality Rates

  within 30 and 60 days of starting treatment.

Study Arms (2)

D/IA (Daunorubicin/Idarubicin + Cytarabine)

ACTIVE COMPARATOR

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.

Drug: Daunorubicin/Idarubicin; Drug: Cytarabine; Drug: Azacitidine; Drug: Venetoclax

VA Regimen

EXPERIMENTAL

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.

Drug: Cytarabine; Drug: Azacitidine; Drug: Venetoclax

Interventions

Daunorubicin/Idarubicin DRUG

Daunorubicin/Idarubicin is used in Induction Therapy and Maintenance Therapy.

D/IA (Daunorubicin/Idarubicin + Cytarabine)

Cytarabine DRUG

Cytarabine is used in Induction Therapy, Consolidation Therapy and Maintenance Therapy.

D/IA (Daunorubicin/Idarubicin + Cytarabine); VA Regimen

Azacitidine DRUG

Azacitidine is used in VA regimen

D/IA (Daunorubicin/Idarubicin + Cytarabine); VA Regimen

Venetoclax DRUG

Venetoclax is used in VA regimen

D/IA (Daunorubicin/Idarubicin + Cytarabine); VA Regimen

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Blood Diseases Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Daunorubicin; Idarubicin; Cytarabine; Azacitidine; venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Aza Compounds; Ribonucleosides

Study Officials

• Hui Wei, MD

  Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Wei, MD

CONTACT

13132507161; weihui@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 20, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)