Trial Information

Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults

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.