drugset / Trial / NCT02313389

Maintenance Treatment Versus Observation in Elderly Patients With PCNS Lymphoma

NCT02313389

Phase 3 Unknown 428 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

Summary

Hypothesis Our hypothesis is that maintenance chemotherapy will prolong complete remission obtained after a standard induction chemotherapy with an acceptable toxicity in the elderly. Rationale * Treatment of the elderly is challenging, indeed age over 60 is associated both with a poor prognosis and a high risk of treatment induced neurotoxicity with devastating consequences on quality of life. Therefore it has become standard practice to treat elderly in first line with high-dose methotrexate (MTX) based polychemotherapy alone, avoiding whole brain radiotherapy (WBRT) or deferring it for recurrence. * There is a clear need to improve disease control after induction chemotherapy. Since consolidation with WBRT or intensive chemotherapy with autologous stem cell rescue are either poorly effective and/or too toxic in the elderly population, maintenance chemotherapy is an interesting alternative approach. Several agents, such as high-dose MTX, temozolomide (TMZ), rituximab, with a reported activity in PCNSL and acceptable safety profile, as single agent or combined, are good candidates for maintenance

Timeline

Start
2015-09
Primary completion
2023-04
Completion
2023-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Methotrexate Small molecule 3500 mg/m2
Subject Rituximab Monoclonal antibody
Subject Temozolomide Small molecule