NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000157

Registered date:12/09/2005

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)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedAcute Myeloid Leukemia
Date of first enrollment2001/12/01
Target sample size850
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Daunorubicin Idarubicin High-Dose Cytarabine Sequential Multiagent Chemotherapy

Outcome(s)

Primary OutcomeComplete remission rate in induction therapy Relapse-free survival
Secondary OutcomeOverall survival Toxicity more than grade 2

Key inclusion & exclusion criteria

Age minimum15years-old
Age maximum65years-old
GenderMale and Female
Include criteria1. Newly diagnosed AML (except M3) 2. PS 0-3 (ECOG) 3. Adequate hepatic, renal, pulmonary and cardiac function 4. Written informed consent
Exclude criteria1. 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

Related Information

Contact

public contact
Name Shigeki Ohtake
Address 5-11-80 Kodatsuno, Kanazawa, Ishikawa Japan
Telephone 076-265-2602
E-mail sohtake@med3.m.kanazawa-u.ac.jp
Affiliation JALSG AML201 Study Office Kanazawa University, Graduate School of Medical Science, Department of Clinical Laboratory Science
scientific contact
Name Shigeki Ohtake
Address 5-11-80 Kodatsuno, Kanazawa, Ishikawa Japan
Telephone 076-265-2602
E-mail
Affiliation Kanazawa University, Graduate School of Medical Science Department of Clinical Laboratory Science