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) studied | Acute Myeloid Leukemia |
| Date of first enrollment | 2001/12/01 |
| Target sample size | 850 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Daunorubicin Idarubicin High-Dose Cytarabine Sequential Multiagent Chemotherapy |
Outcome(s)
| Primary Outcome | Complete remission rate in induction therapy Relapse-free survival |
|---|---|
| Secondary Outcome | Overall survival Toxicity more than grade 2 |
Key inclusion & exclusion criteria
| Age minimum | 15years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Japan Adult Leukemia Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labor and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shigeki Ohtake |
| Address | 5-11-80 Kodatsuno, Kanazawa, Ishikawa Japan |
| Telephone | 076-265-2602 |
| 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 |
| Affiliation | Kanazawa University, Graduate School of Medical Science Department of Clinical Laboratory Science |