Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131027
Status:
UNKNOWN
Last Update Posted:
2008-11-14
First Post:
2005-08-15
Brief Title:
High-Dose Methotrexate MTX for Adult Acute Lymphoblastic Leukemia ALL
Sponsor:
Japan Adult Leukemia Study Group
Organization:
Japan Adult Leukemia Study Group
Study Overview
Official Title:
Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults
Status:
UNKNOWN
Status Verified Date:
2008-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None