UMIN ID: UMIN000000823
Registered date:15/09/2007
Phase III Randomized Study of Imatinib therapy in chornic phase chronic myeloid leukemia comparing standard dose-escalation with progressive dose-escalation (JALSG CML207study)
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Previously untreated Chronic-phase chronic myelogenous leukemia |
| Date of first enrollment | 2007/06/01 |
| Target sample size | 240 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | imatinib imatinib |
Outcome(s)
| Primary Outcome | Molecular response at 12 months of imatinib therapy |
|---|---|
| Secondary Outcome | 1 Overall survival at three years 2 Cytogenetic response at 2 years 3 Adverse events grade 3 and more |
Key inclusion & exclusion criteria
| Age minimum | 15years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Other active neoplasma 2. Severe infection 3. Anticancer drug other than hydoroxurea in 2 weeks 4. Severe psychological disorders such as shizophrenia 5. Pregnant and/or lactating woman 6. Uncontorlled diabetis meritis 7. Acute myocardial infarction in 1 year or history of heart failure 8. Liver chirosis 9. Otherwise eligible |
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 | Koichi Miyamura |
| Address | 3-35 Michishita-cho, Nakamura-ku, Nagoya Japan |
| Telephone | 052-481-511 |
| miyamu@nagoya-1st.jrc.or.jp | |
| Affiliation | Japanese Red Cross Nagoya First Hospital Department of hematology |
| scientific contact | |
| Name | Koichi Miyamura |
| Address | 3-35 Michishita-cho, Nakamura-ku, Nagoya Japan |
| Telephone | 052-481-511 |
| Affiliation | Japanese Red Cross Nagoya First Hospital Department of Hematology |