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

UMIN ID: C000000290

Registered date:01/12/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Philadelphia Chromosome-positive acute lymphoblastic leukemia
• Date of first enrollment: 2004/11/01
• Target sample size: 56
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): The effect of imatinib mesylate monotherapy will be assessed using a molecular technique before the hematopoietic stem cell transplantation.

Outcome(s)

• Primary Outcome: To determine the efficacy of imatinib mesylate for children with Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) assessed by a molecular quantification technique.
• Secondary Outcome: To 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 minimum: 1years-old
• Age maximum: 18years-old
• Gender: Male and Female
• Exclude criteria: Intracranial 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

• Primary Sponsor: Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare