Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114348
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2005-06-14
Brief Title:
ALL-REZ BFM 2002 Multi-Center Study for Children With Relapsed Acute Lymphoblastic Leukemia
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
ALL-REZ BFM 2002 Protocol for the Treatment of Children With Relapsed Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2013-02
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 protocol ALL-REZ BFM 2002 aims at the optimization of treatment for children with relapsed acute lymphoblastic leukemia The primary objective of study ALL-REZ BFM 2002 is the randomized comparison of a lower dosed and less intensive but continuous consolidation therapy with conventional therapy administered in treatment blocks Outcome measures are the reduction of minimal residual disease MRD event-free and overall survival and the toxicity associated with each treatment strategy
Detailed Description:
The study is based on the results of five consecutive trials performed by the ALL-REZ BFM study group since 1983 Thus the study meets the criteria of evidence-based therapy which has been developed over nearly 20 years Multi-agent chemotherapy in short intensive courses which are separated by treatment-free intervals has proved to be a successful form of induction and consolidation therapy It is followed by preventative or therapeutic cranial irradiation and continuation therapy A number of risk factors particularly the time of relapse site of relapse and the ALL immunophenotype allow the stratification of patients into a group that has an acceptable prognosis after treatment with chemotherapy alone and a second group that has a high risk of subsequent recurrence following the achievement of a second remission The latter group requires further intensification of consolidation therapy by allogenic stem cell transplantation SCT To date the indication for SCT has remained unclear for a large and heterogeneous group of patients with an intermediate prognosis During the precursor study ALL-REZ BFM 96 however the amount of minimal residual disease MRD determined quantitatively with clonal molecular markers after the second induction therapy element was shown to be a highly significant predictor of relapse-free survival
The primary objective of study ALL-REZ BFM 2002 is the randomized comparison of a lower dosed and less intensive but continuous consolidation therapy with conventional therapy administered in treatment blocks Outcome measures are the reduction of MRD event-free and overall survival and the toxicity associated with each treatment strategy
The secondary objectives include an improvement of the prognosis in the intermediate risk group using the stratification in treatment arms with and without allogenic SCT based on the MRD result after the second treatment element of induction therapy An additional aim is to improve the remission induction rate in all groups by increasing the treatment intensity during induction This is achieved by shortening the intervals between treatment blocks in keeping with the principles of guiding therapy as defined in the protocol A series of biological companion studies aims to advance our understanding of the disorder and to establish novel prognostic factors that will allow a risk-adapted therapy
The primary objective of study ALL-REZ BFM 2002 is the randomized comparison of a lower dosed and less intensive but continuous consolidation therapy with conventional therapy administered in treatment blocks Outcome measures are the reduction of MRD event-free and overall survival and the toxicity associated with each treatment strategy
The secondary objectives include an improvement of the prognosis in the intermediate risk group using the stratification in treatment arms with and without allogenic SCT based on the MRD result after the second treatment element of induction therapy An additional aim is to improve the remission induction rate in all groups by increasing the treatment intensity during induction This is achieved by shortening the intervals between treatment blocks in keeping with the principles of guiding therapy as defined in the protocol A series of biological companion studies aims to advance our understanding of the disorder and to establish novel prognostic factors that will allow a risk-adapted 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