Phase III Randomized Study of Induction Therapy Comparing Daunorubicin With Idarubicin Followed By Consolidation Therapy Comparing High-Dose Cytarabine With Sequential Multiagent Chemotherapy in Patients With Previously Untreated De Novo Acute Myeloid Leukemia (JALSG AML201 Study)

Phase III Randomized Study of Induction Therapy Comparing Daunorubicin With Idarubicin Followed By Consolidation Therapy Comparing High-Dose Cytarabine With Sequential Multiagent Chemotherapy in Patients With Previously Untreated De Novo Acute Myeloid Leukemia (JALSG AML201 Study) - Randomized Study of Induction and Consolidation Therapy in Patients With Previously Untreated AML (JALSG AML201 Study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000157

Enrollment

850

Registered

2005-09-12

Start date

2001-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Interventions

Daunorubicin Idarubicin High-Dose Cytarabine Sequential Multiagent Chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed AML (except M3) 2. PS 0-3 (ECOG) 3. Adequate hepatic, renal, pulmonary and cardiac function 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Atypical leukemia 2. History of MDS 3. History of cancer chemotherapy 4. Other active neoplasms 5. Recent history of myocardial infarction or renal failure, 6. Severe comorbidity (diabetes mellitus, infection or liver cirrhosis) 7. Psychological disorders 8. Pregnant and/or lactating woman 9. Positive anti-HIV antibody

Design outcomes

Primary

Measure	Time frame
Complete remission rate in induction therapy Relapse-free survival	—

Secondary

Measure	Time frame
Overall survival Toxicity more than grade 2	—

Countries

Japan

Contacts

Public ContactShigeki Ohtake

JALSG AML201 Study Office Kanazawa University, Graduate School of Medical Science, Department of Clinical Laboratory Science

sohtake@med3.m.kanazawa-u.ac.jp076-265-2602

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026