Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222027
Status:
COMPLETED
Last Update Posted:
2009-01-07
First Post:
2005-09-13
Brief Title:
Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia a Multicenter Trial
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
GRAALL 2003 Trial ALL 15-59 Years Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia a Multicenter Trial
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
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:
GRAALL2003
Brief Summary:
Several prognostic predictors including baseline ALL features and response to initial therapy have been described in adult ALL raising the issue of whether these predictors might be redundant and which must be considered for treatment stratification In the GRAALL-2003 prospective Phase 2 study we aim to hierarchize the following high-risk factors in Ph-negative ALL patients
Detailed Description:
1 baseline BL WBC30GL in B-lineage CNS involvement MLL-AF4 and E2A-PBX fusions haploidynear-triploidy 2 early response ER corticoresistance after prophase CsR chemoresistance at Day 8 ChR all CsR andor ChR patients are planned to receive higher doses of cyclophosphamide HyperC at Day 15 of induction 3 induction response IR no CR or Ig-TCR minimal residual disease MRD 10-2 after standard or HyperC induction Allogeneic stem cell transplantation is proposed to patients with a donor and at least one BL ER or IR factor
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHRC | None | None | None |