Ignite Creation Date:
2024-05-06 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03590171
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2018-05-23
Brief Title:
International Study for Treatment of High Risk Childhood Relapsed ALL 2010
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
International Study for Treatment of High Risk Childhood Relapsed ALL 2010 A Randomized Phase II Study Conducted by the Resistant Disease Committee of the International Berlin Frankfurt Münster BFM Study Group
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents
Detailed Description:
Though survival of children with acute lymphoblastic leukemia ALL has considerably improved over the past few decades relapsed ALL remains a leading cause of mortality in children with cancer Risk has been defined by the International I Berlin Frankfurt Münster BFM Study Group SG based on duration of first remission immunophenotype of malignant clone and site of relapse Patients classified as high risk HR by these criteria have poor response rates to standard induction therapy high rates of subsequent relapse and require an allogeneic hematopoetic stem cell transplantation allo-HSCT for consolidation of 2nd remission Over the last decade members of the I-BFM-SG have investigated the use of different combinations of conventional cytotoxic agents Even with allo-HSCT none of these approaches have improved outcome above 40 Therefore for HR patients there is a need to investigate the curative potential of new agents combined with systemic therapy The proteasome inhibitor bortezomib has shown synergistic activity with acceptable toxicity when combined with corticosteroids anthracyclines and alkylating agents in adult patients with cancer as well as with dexamethasone doxorubicin vincristine and polyethylene glycol PEG asparaginase in children with refractory or relapsed ALL In the I-BFM-SG International Study for Treatment of High Risk Childhood Relapsed ALL IntReALL HR 2010 study the potential of Bortezomib combined with a modified ALL relapse protocol 3 R3 backbone as induction regimen for HR patients to improve complete 2nd remission CR2 rates will be investigated in a randomized phase II design Induction is followed by conventional intensive consolidation After termination of the trial patients may be subjected to an investigational window before all of them receive allo-HSCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None