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

Lymphoblastic Leukemia, Acute Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoblastic Leukemia, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT00131027
• Study type: Interventional
• Source: Japan Adult Leukemia Study Group
• Contact: Fumihiko Hayakawa, MD
• Email: bun-hy@med.nagoya-u.ac.jp
• Status: Recruiting
• Phase: Phase 3
• Start date: September 2002
• Completion date: September 2011