Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287105
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2006-02-03
Brief Title:
Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph Acute Lymphoblastic Leukemia in Children
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
An Open-label Phase II Study to Explore the Safety and Efficacy of Imatinib With Chemotherapy in Pediatric Patients With Ph BCR-ABL Acute Lymphoblastic Leukemia PhALL
Status:
COMPLETED
Status Verified Date:
2023-05
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:
ESPHALL
Brief Summary:
The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of PhALL in children
Detailed Description:
Recent advances in treatment have increased the cure of childhood ALL to 75 or better However attempts to improve results for resistant subtypes of ALL such as Ph ALL have been largely unsuccessful Imatinib an inhibitor of protein-tyrosine kinases is currently being tested in several phase I II and III trials covering most Chronic Myeloid Leukemia patient populations and patients with overtly relapsed or refractory PhALL Pediatric patients with PhALL will receive Imatinib added to intensive post-induction BFM-type chemotherapy The endpoint will be the evaluation on the long-term clinical outcome in particular on the Disease Free Survival DFS
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 |
|---|---|---|---|
| PHRC04-04 | None | None | None |
| CIC0203043 | None | None | None |