Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131053
Status:
UNKNOWN
Last Update Posted:
2008-11-14
First Post:
2005-08-15
Brief Title:
Applying Pediatric Regimens to Younger Adult Patients With Acute Lymphoblastic Leukemia ALL
Sponsor:
Japan Adult Leukemia Study Group
Organization:
Japan Adult Leukemia Study Group
Study Overview
Official Title:
Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients With BCR-ABL-Negative Acute Lymphoblastic Leukemia
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 efficacy and safety for treating adult ALL patients with the pediatric protocol
Detailed Description:
The prognosis for adult acute lymphoblastic leukemia ALL remains poor which contrasts with that for pediatric ALL It is regarded that the prognostic diversity is attributable to several differences between adults and children with respect to biological characteristics of leukemic cells tolerance to anticancer drugs treatment itself and so on It has been reported that adolescent ALL patients who were treated according to the pediatric protocol had a significantly better survival than those who were treated according to the adult protocol indicating that the difference of treatment may be of considerable importance To test the hypothesis the Japan Adult Leukemia Study Group JALSG has planned a phase 2 study to treat younger ALL patients who are negative for BCR-ABL with the pediatric regimen which was used by the Japan Association of Childhood Leukemia Study Those who are positive for BCR-ABL can participate in a separate protocol The regimen is especially characterized by dose-intensified L-asparaginase high-dose methotrexate and intensified maintenance therapy
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