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

Condition	Intervention	Phase
Acute Lymphoblastic Leukemia	Drug: imatinib  Drug: cyclophosphamide  Drug: daunorubicin  Drug: vincristine  Drug: prednisolone  Drug: methotrexate  Drug: cytarabine  Drug: dexamethasone	Phase II

Further Study Details: 

Primary Outcomes: The rate of complete remission
Secondary Outcomes: The duration of remission; Overall survival at one year; Toxicity caused by combination of imatinib and chemotherapy
Expected Total Enrollment:  100

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.

Ages Eligible for Study:  15 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Previously untreated BCR-ABL-positive ALL
• Age between 15 and 64 years
• Performance status between 0 and 3 (ECOG criteria)
• Adequate functioning of the liver (serum bilirubin level < 2.0 mg/dL), kidneys (serum creatinine level < 2.0 mg/dL), and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs)
• Written informed consent to participate the trial

Exclusion Criteria:

• Uncontrolled active infection
• Another severe and/or life-threatening disease
• Positive for HIV antibody and/or HBs antigen tests
• Another primary malignancy which is clinically active and/or requires medical interventions
• Pregnant and/or lactating woman
• Past history of renal failure

Japan
      Department of Hematology, Nagoya University Graduate School of Medicine, Nagoya,  466-8550,  Japan

Study chairs or principal investigators

Masamitsu Yanada, MD,  Study Director,  Nagoya University Graduate School of Medicine   
Tomoki Naoe, MD,  Study Chair,  Nagoya University Graduate School of Medicine   

Study ID Numbers:  JALSG Ph+ALL202
Last Updated:  August 17, 2005
Record first received:  August 12, 2005
ClinicalTrials.gov Identifier:  NCT00130195
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-08-23