NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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) studiedPreviously untreated Chronic-phase chronic myelogenous leukemia
Date of first enrollment2007/06/01
Target sample size240
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)imatinib imatinib

Outcome(s)

Primary OutcomeMolecular response at 12 months of imatinib therapy
Secondary Outcome1 Overall survival at three years 2 Cytogenetic response at 2 years 3 Adverse events grade 3 and more

Key inclusion & exclusion criteria

Age minimum15years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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

Contact

public contact
Name Koichi Miyamura
Address 3-35 Michishita-cho, Nakamura-ku, Nagoya Japan
Telephone 052-481-511
E-mail 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
E-mail
Affiliation Japanese Red Cross Nagoya First Hospital Department of Hematology