High-Dose Methotrexate (MTX) for Adult Acute Lymphoblastic Leukemia (ALL)

• Status: Unknown status
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Adult Leukemia Study Group
• Treatments: 6-Mercaptopurine; Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Doxorubicin; Etoposide; Mercaptopurine; Methotrexate; Prednisolone; Vincristine

Criteria

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