drugset / Trial / NCT03495960

Study on Tailored Treatment in Elderly Patients With Newly Diagnosed Primary Lymphoma of Central Nervous System

NCT03495960

RandomizedParallel-groupOpen-labelTreatment

Summary

Primary central nervous system lymphomas are rare aggressive malignancies, usually treated in two steps: an induction phase (where a combination of chemotherapy is given) followed by a consolidation phase (where patients usually receive one of the following: whole-brain irradiation, chemotherapy supported by autologous stem-cell transplantation, other type of chemotherapy, or are just observed). The feasibility of this overall strategy, for several reasons, is limited in elderly patients . This study involves patients aged ≥70 years. The more fit patients will receive the standard chemotherapy combination (high-dose methotrexate, procarbazine and rituximab) as induction. Responding patients will receive either procarbazine or lenalidomide as maintenance therapy; the aim is to evaluate the efficacy of these two drugs. The more fragile patients will receive a less aggressive therapy consisting of concomitant whole-brain radiotherapy, temozolomide and rituximab as induction therapy, followed by temozolomide as maintenance treatment; the aim is to evaluate the efficacy of this combination of treatment.

Timeline

Start
2019-06-15
Primary completion
2024-12-12
Completion
2024-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified 25 mg Oral
Subject Methotrexate Small molecule 3 g Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Temozolomide Small molecule 200 mg/m2
Subject procarbazine Small molecule 100 mg