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

Japan Adult Leukemia Study Group

Status and phase

Completed

Phase 2

Conditions

Acute Lymphoblastic Leukemia

Treatments

Drug: cyclophosphamide

Drug: dexamethasone

Drug: prednisolone

Drug: vincristine

Drug: methotrexate

Drug: imatinib

Drug: daunorubicin

Drug: cytarabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00130195

JALSG Ph+ALL202

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

15 to 64 years old

Volunteers

No Healthy Volunteers

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 in the trial

Exclusion criteria

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