drugset / Trial / NCT03390387

Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2015 (ALL-MB 2015)

NCT03390387

RandomizedParallel-groupOpen-labelTreatment

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 WBC≥100,000/µl 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?

Timeline

Start
2015-11
Primary completion
2020-11
Completion
2025-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 1000 mg/m2 Intravenous
Subject Cytarabine Small molecule 75 mg/m2 Intravenous
Comparator Daunorubicin Small molecule 30 mg/m2 Intravenous
Comparator Daunorubicin Small molecule 45 mg/m2 Intravenous
Comparator Dexamethasone Small molecule 6 mg/m2 Oral
Subject Idarubicin Small molecule 8 mg/m2 Intravenous
Subject Idarubicin Small molecule 10 mg/m2 Intravenous
Subject MERCAPTOPURINE ANHYDROUS Small molecule 50 mg/m2 Oral
Subject MERCAPTOPURINE ANHYDROUS Small molecule 60 mg/m2 Oral
Comparator Methotrexate Small molecule 30 mg/m2 Intramuscular
Subject Methylprednisolone Other / unclassified 60 mg/m2 Oral
Comparator Prednisone Other / unclassified Intrathecal
Comparator Vincristine Small molecule 1.5 mg/m2 Intravenous
Comparator asparaginase Protein / enzyme biologic 10000 iu Intramuscular