drugset / Trial / NCT02531841

High-dose Chemotherapy and ASCT or Consolidating Conventional Chemotherapy in Primary CNS Lymphoma

NCT02531841

RandomizedParallel-groupOpen-labelTreatment

Summary

In the presently planned multicentre Phase III trial the two therapies will be compared: Patients will be randomized after intensified induction treatment with 4 cycles rituximab, methotrexate, cytarabine and thiotepa (MATRix) between first-line high-dose chemotherapy against conventional consolidating therapy with 2 cycles of conventional chemotherapy with R-DeVIC (rituximab, dexamethasone, etoposide, ifosfamide, carboplatin).

Timeline

Start
2014-07
Primary completion
2017-11
Completion
2019-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Busulfan Small molecule 3.2 mg/kg Intravenous
Comparator Carboplatin Small molecule 300 mg/m2 Intravenous
Comparator Dexamethasone Small molecule 40 mg Intravenous
Comparator Etoposide Small molecule 100 mg/m2 Intravenous
Comparator Ifosfamide Small molecule 1500 mg/m2 Intravenous
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Comparator Thiotepa Other / unclassified 5 mg/kg Intravenous
Comparator Thiotepa Other / unclassified 30 mg/m2 Intravenous
Comparator carmustine Small molecule 400 mg/m2 Intravenous
Comparator Arm A (Fortecortin®-ETOPOPHOS®-IFO-cell®-CARBO-cell®) Unknown 2000 mg/m2 Intravenous
Comparator Methotrexate Small molecule 3500 mg/m2 Intravenous