NIPH Clinical Trials Search

UMIN ID: C000000290

Registered date:01/12/2005

Phase II study of imatinib mesylate for treatment of Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in children: A Japanese Cooperative Trial

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedPhiladelphia Chromosome-positive acute lymphoblastic leukemia
Date of first enrollment2004/11/01
Target sample size56
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)The effect of imatinib mesylate monotherapy will be assessed using a molecular technique before the hematopoietic stem cell transplantation.


Primary OutcomeTo determine the efficacy of imatinib mesylate for children with Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) assessed by a molecular quantification technique.
Secondary OutcomeTo evaluate the event-free survival for patients with Ph+ ALL assessed by a life table analysis, To evaluate the rate of patients who receive allogeneic stem cell transplantation (SCT) in the first complete remission (CR). To evaluate the safety of the regimen.

Key inclusion & exclusion criteria

Age minimum1years-old
Age maximum18years-old
GenderMale and Female
Include criteria
Exclude criteriaIntracranial hemorrhage. Heart failure requiring treatment. Chronic renal failure. Active uncontrolled infections. Diabetes mellitus. Liver chirrhosis. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent. Female patients who are pregnant or breast-feeding.

Related Information


public contact
Name Tetsuya Takimoto
Address National Nagoya Hospital, 4-1-1, San-nomaru, Naka-ku, Nagoya Japan
Telephone 052-951-1111
Affiliation JPLSG Data Center
scientific contact
Name Atsushi Manabe
Address 9-1, Akashi-cho, Chuo-ku, Tokyo, 104-8560 Japan
Telephone 03-3-3541-5151
Affiliation St. Luke's International Hospital Department of Pediatrics,