Ignite Creation Date:
2024-05-06 @ 2:01 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01953770
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2013-09-26
Brief Title:
Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2008
Sponsor:
Federal Research Institute of Pediatric Hematology Oncology and Immunology
Organization:
Federal Research Institute of Pediatric Hematology Oncology and Immunology
Study Overview
Official Title:
Moscow-Berlin 2008 Multicenter Randomised Study for Treatment of Acute Lymphoblastic Leukemia in Children and Adolescents
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
ACTIVE_NOT_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:
ALL-MB 2008
Brief Summary:
QUESTIONS AND OBJECTIVES OF ALL-MB-2008 STUDY
1 Whether the early PEG-asparaginase in induction will lead to the earlier achievement of remission improvement of days 8 and 15 responses leading to an earlier reconstitution of bone marrow and immunocompetence decrease of severe infections and early mortality rate
2 Whether the use of PEG-asparaginase in induction will allow to avoid the anthracyclines in standard risk group patients and to reduce treatment myelotoxicity
3 Whether the administration of 9 doses of PEG-asparaginase 1000 Um2 instead of 18 doses of Ecoli L-asparaginase 5000 Um2 in standard risk patients will improve treatment outcome
4 Whether the administrations of high dose methotrexate 2 gm2 in 24 hours during 1-st consolidation in intermediate risk patients will result in decrease of central nervous system relapse incidence and improvement of event-free and overall survival Whether the increase of 6-mercaptopurine starting dose up to 50 mgm2 in 1-st consolidation phase instead of 25 mgm2 will decrease in relapse risk but would not be accompanied with enhanced toxicity
5 Is it possible to completely avoid the cranial irradiation in intermediate risk patients In some subgroup of intermediate risk patients Is it enough to control neuroleukemia in these patients to introduce additional TIT in the consolidation phase of treatment How will change the possible late effects in these patients according to the third arm of randomization
6 Will the new risk group stratification to improve overall and event-free survival
1 Whether the early PEG-asparaginase in induction will lead to the earlier achievement of remission improvement of days 8 and 15 responses leading to an earlier reconstitution of bone marrow and immunocompetence decrease of severe infections and early mortality rate
2 Whether the use of PEG-asparaginase in induction will allow to avoid the anthracyclines in standard risk group patients and to reduce treatment myelotoxicity
3 Whether the administration of 9 doses of PEG-asparaginase 1000 Um2 instead of 18 doses of Ecoli L-asparaginase 5000 Um2 in standard risk patients will improve treatment outcome
4 Whether the administrations of high dose methotrexate 2 gm2 in 24 hours during 1-st consolidation in intermediate risk patients will result in decrease of central nervous system relapse incidence and improvement of event-free and overall survival Whether the increase of 6-mercaptopurine starting dose up to 50 mgm2 in 1-st consolidation phase instead of 25 mgm2 will decrease in relapse risk but would not be accompanied with enhanced toxicity
5 Is it possible to completely avoid the cranial irradiation in intermediate risk patients In some subgroup of intermediate risk patients Is it enough to control neuroleukemia in these patients to introduce additional TIT in the consolidation phase of treatment How will change the possible late effects in these patients according to the third arm of randomization
6 Will the new risk group stratification to improve overall and event-free survival
Detailed Description:
None
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