Ignite Creation Date:
2024-05-06 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03390387
Status:
RECRUITING
Last Update Posted:
2020-02-05
First Post:
2017-12-27
Brief Title:
Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2015 ALL-MB 2015
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 2015 Multicenter Randomized Study for Treatment of Acute Lymphoblastic Leukemia in Children Adolescents and Young Adults
Status:
RECRUITING
Status Verified Date:
2020-02
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:
ALL-MB 2015
Brief Summary:
QUESTIONS AND OBJECTIVES OF ALL-MB 2015 STUDY
1 Will the new risk group stratification especially of T-ALL to improve overall and event-free survival
2 Will the new protocol is effective and feasible in patients older than 15 years and especially in young adults
3 Whether the intermittent dexamethasone administration in induction will result in a decrease in toxicity and mortality without loss of efficacy
4 Whether the methylprednisolone administration as basic glucocorticoids during induction consolidation and maintenance therapy will lead to decrease of severe infections and early mortality rate improve survival and therapy compliance in adolescents and young adults with B-precursor ALL
5 Whether the administration of Bortezomib in patients with B-precursor ALL with initial WBC100000µl will improve treatment outcome
6 Whether the administration of Idarubicin instead Daunorubicin in low-risk T-ALL patients and two-phase induction in intermediate-risk T-ALL patients will reduce relapse rate and improve survival
1 Will the new risk group stratification especially of T-ALL to improve overall and event-free survival
2 Will the new protocol is effective and feasible in patients older than 15 years and especially in young adults
3 Whether the intermittent dexamethasone administration in induction will result in a decrease in toxicity and mortality without loss of efficacy
4 Whether the methylprednisolone administration as basic glucocorticoids during induction consolidation and maintenance therapy will lead to decrease of severe infections and early mortality rate improve survival and therapy compliance in adolescents and young adults with B-precursor ALL
5 Whether the administration of Bortezomib in patients with B-precursor ALL with initial WBC100000µl will improve treatment outcome
6 Whether the administration of Idarubicin instead Daunorubicin in low-risk T-ALL patients and two-phase induction in intermediate-risk T-ALL patients will reduce relapse rate and improve survival
Detailed Description:
None
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