drugset / Trial / NCT04043494

International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

NCT04043494 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

Primary objectives: * Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm) * Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)

Timeline

Start
2019-08-23
Primary completion
2030-04-22
Completion
2030-04-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule — —
Subject Ifosfamide Small molecule — —
Subject Methotrexate Small molecule — —
Subject Pegaspargase Protein / enzyme biologic — —
Subject Prednisone Other / unclassified — —
Subject Vindesine Small molecule — —
Background Cyclophosphamide Other / unclassified — —
Background Cytarabine Small molecule — —
Background Daunorubicin Small molecule — —
Background Doxorubicin Other / unclassified — —
Background MERCAPTOPURINE ANHYDROUS Small molecule — —
Background Prednisolone Other / unclassified — —
Background Thioguanine Small molecule — —
Background Vincristine Small molecule — —