UMIN ID: C000000153
Registered date:10/09/2005
Study of imatinib monotherapy and combination of imatinib with IFN or cytarabine ocfosfate for chronic-phase CML (JALSG CML202 Study)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Previously untreated chronic-phase chronic myelogenous leukemia |
| Date of first enrollment | 2002/04/01 |
| Target sample size | 300 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Imatinib Imatinib+Interferon-alpha Imatinib+Cytarabine ocfosfate |
Outcome(s)
| Primary Outcome | 1) Imatinib monotherapy: overall survival 2) Combination therapy: cytogenetic response at 9 months |
|---|---|
| Secondary Outcome | 1) Imatinib monotherapy: toxicity, hematologic response at 6 months, cytogenetic response at 9 months, progression free survival, time to treatment failure 2) Combination therapy: toxicity, hematologic response, cytogenetic response, overall survival, progression free survival, time to treatment failure |
Key inclusion & exclusion criteria
| Age minimum | 15years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Other active neoplasms 2. Severe comorbidity 3. Hypersensitivity to imatinib 4. Previously treated with IFN 5. Psychological disorders 6. Pregnant and/or lactating woman 7. CML in accelerated phase or blast crisis |
Related Information
| Primary Sponsor | Japan Adult Leukemia Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour, and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kazunori Ohnishi |
| Address | 1-20-1, Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan Japan |
| Telephone | 053-433-4993 |
| jalsgsc@hama-med.ac.jp | |
| Affiliation | JALSG CML202 Study Office Hamamatsu University School of Medicine, Division of Clinical Oncology |
| scientific contact | |
| Name | Kazunori Ohnishi |
| Address | 1-20-1, Handayama, Higashi-ku,Hamamatsu, 431-3192, Japan Japan |
| Telephone | 053-433-4993 |
| kohnishi@hama-med.ac.jp | |
| Affiliation | Hamamatsu University School of Medicine Division of Clinical Oncology |