The purpose of this study is to investigate the clinical efficacy of high-dose methotrexate consolidation therapy for adult patients with BCR-ABL-negative ALL.

Although the multi-agent chemotherapies in current use produce complete remission for a majority of patients with acute lymphoblastic leukemia (ALL), the prognosis for adult ALL remains discouraging due to a high incidence of relapse. Optimal post-remission therapy, therefore, has been a matter of vital concern. In some pediatric ALL studies, the use of high-dose methotrexate (MTX) as a consolidation therapy, has been shown to improve outcome, however, there has been no randomized controlled trials to test its clinical efficacy in adult ALL. With this concern, the Japan Adult Leukemia Study Group (JALSG) has planned a prospective randomized controlled trial comparing high-dose MTX and intermediate-dose MTX for ALL patients who are negative for BCR-ABL. Those who are positive for BCR-ABL can participate in a separate protocol.

Inclusion Criteria:

• Previously untreated BCR-ABL-negative ALL
• Age between 25 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