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

NCT ID: NCT07132684

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2028-08-30

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 60-75) with acute myeloid leukemia (AML) who are fit for intensive chemotherapy.

Conditions

AML, Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

D/IA (Daunorubicin/Idarubicin + Cytarabine)

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 Ara-C 1g/m² Q12h, d1-3 (aged ≥60 and <70 years) or Ara-C 500mg/m² Q12h d1-3 (aged ≥70 years)

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.

Group Type: ACTIVE_COMPARATOR

Daunorubicin/Idarubicin

Intervention Type: DRUG

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

Cytarabine

Intervention Type: DRUG

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

Azacitidine

Intervention Type: DRUG

Azacitidine is used in VA regimen

Venetoclax

Intervention Type: DRUG

Venetoclax is used in VA regimen

VA Regimen

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 Ara-C 1g/m² Q12h, d1-3 (aged ≥60 and <70 years) or Ara-C 500mg/m² Q12h d1-3 (aged ≥70 years)

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.

Group Type: EXPERIMENTAL

Cytarabine

Intervention Type: DRUG

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

Azacitidine

Intervention Type: DRUG

Azacitidine is used in VA regimen

Venetoclax

Intervention Type: DRUG

Venetoclax is used in VA regimen

Interventions

Daunorubicin/Idarubicin

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

Intervention Type: DRUG

Cytarabine

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

Intervention Type: DRUG

Azacitidine

Azacitidine is used in VA regimen

Intervention Type: DRUG

Venetoclax

Venetoclax is used in VA regimen

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of AML according to WHO (2022) or ICC criteria.
• Age ≥60 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui Wei, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Blood Diseases Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hui Wei, MD

Role: CONTACT

weihui@ihcams.ac.cn

13132507161

Facility Contacts

Hui Wei, MD

Role: primary

weihui@ihcams.ac.cn

86-13132507161

Other Identifiers

IIT2025095

Identifier Type: -

Identifier Source: org_study_id