drugset / Trial / NCT04043494
International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
Phase 3
Recruiting
683 enrolled
University Hospital Muenster
Deutsche Krebshilfe e.V., Bonn (Germany) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |