NCT00130195

Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)

Phase 2 Study of Imatinib-Combined Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Japan Adult Leukemia Study Group · Academic / Other
• Sex: All
• Age: 15 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the clinical efficacy and safety of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.

Detailed description

Philadelphia chromosome (Ph) is a translocation abnormality leading to the formation of the BCR-ABL gene rearrangement. This genetic abnormality occurs in up to 30% of adult acute lymphoblastic leukemia (ALL), and its presence is known to be the most adverse prognostic factor for ALL. Because long-term survival cannot be achieved by conventional chemotherapy alone, there is a clear medical need for alternative treatment approaches. Imatinib is a potent selective inhibitor of the BCR-ABL protein kinase, and it has been reported that single-agent imatinib induced response in a substantial proportion of Ph-positive ALL (Ph+ALL) patients, but that the response was not durable. The Japan Adult Leukemia Study Group (JALSG) has therefore started a phase 2 study designed to evaluate the clinical effect of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	imatinib
DRUG	cyclophosphamide
DRUG	daunorubicin
DRUG	vincristine
DRUG	prednisolone
DRUG	methotrexate
DRUG	cytarabine
DRUG	dexamethasone

Timeline

• Start date: 2002-09-01
• Primary completion: 2008-02-01
• Completion: 2008-05-01
• First posted: 2005-08-15
• Last updated: 2008-11-14

Locations

1 site across 1 country: Japan