NCT00131027

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Japan Adult Leukemia Study Group · Academic / Other
• Sex: All
• Age: 25 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lymphoblastic Leukemia, Acute

Interventions

Type	Name	Description
DRUG	Cyclophosphamide
DRUG	Daunorubicin
DRUG	Vincristine
DRUG	Prednisolone
DRUG	L-asparaginase
DRUG	Cytarabine
DRUG	Etoposide
DRUG	Dexamethasone
DRUG	Methotrexate	3 g/sqm (high dose)
DRUG	Mercaptopurine
DRUG	Doxorubicin
DRUG	Methotrexate	0.5 g/sqm (intermediate dose)

Timeline

• Start date: 2002-09-01
• Primary completion: 2011-03-01
• Completion: 2011-09-01
• First posted: 2005-08-17
• Last updated: 2008-11-14

Locations

1 site across 1 country: Japan