Wednesday, November 08, 2023 IND.244 - A Phase 2 Study of Ibrutinib Combination Therapy in Transplant Ineligible Individuals with Newly Diagnosed Primary Central Nervous System Lymphoma has been centrally activated. This study is being done to answer the following question: Can the addition of a new drug to the usual treatment lower the chance of primary central nervous system lymphoma growing or spreading? To understand if this approach is better or worse than the usual approach for this type of cancer. Objectives: Primary: One year progression-free survival (PFS). Secondary: Overall Response Rate (ORR = CR+CRu+PR) and complete response (CR) rate; 1-year event-free survival (EFS); 2-year PFS; Overall survival (OS); To determine the safety and tolerability of ibrutinib, methotrexate, and rituximab treatment in patients with primary central nervous system lymphoma (PCNSL); To determine the impact on patient related outcomes of ibrutinib, methotrexate, and rituximab treatment in patients with PCNSL - Cognitive functioning, Health-related quality of life (FACT-BR) and cognitive symptoms (FACT-Cog). Tertiary: Baseline and serial plasma and cerebrospinal fluid circulating tumour DNA, correlated with outcomes; Radiomic evaluation of predictors of disease response and relapse. For more information please visit the IND244 members trial page.
