I244

I244 Details
Status: On-Hold
Activation Date: 2023OCT24
Phase: II

Description: A Phase 2 Study of Ibrutinib Combination Therapy in Transplant Ineligible Individuals with Newly Diagnosed Primary Central Nervous System Lymphoma

Eligibility: Patients (?18 y/o, ECOG PS 0-2, 3 if due to PCNSL & expected to reverse with treatment) must have histological/cytological evidence of PCNSL; vitreo-retinal/CSF disease eligible with CNS involvement on MRI. No 2? CNS non Hodgkin lymphoma or significant 3rd space fluid which can?t be drained. Must be ineligible for high-dose chemo & ASCT, fit to receive protocol Tx. Consent to release tumour block. No prior radiation/systemic Tx except corticosteroids for PCNSL. ? 8mg/day of dexamethasone (or equivalent) at enrolment & wean within 7 days of starting Tx. Major surgery ?28 days before enrolment (unless for PCNSL) & wounds healed. Able to swallow oral meds, no known GI impairment. No active Tx for other advanced/metastatic malignancy. No serious illnesses/medical conditions precluding management per protocol, no clinically significant cardiac disease (pts with history of cardiac disease: LVEF ?50%). No anticoagulation with warfarin/equivalent or strong CYP3A inhibitor/inducer.

Objective: 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

Participation: Limited to invited centres

Lay Description: The purpose of this study is to test the good and bad effects of the drug called ibrutinib in patients with newly diagnosed primary central nervous system lymphoma. Each of the first 6 cycles of treatment will be 14 days long, and patients will receive methotrexate and rituximab (where available) on the first day of each cycle and ibrutinib on days 6-14 of each cycle. In cycle 7 onwards each cycle of treatment will be 28 days, and patients will take ibrutinib every day. Treatment will continue for two years from the first drug administration or until the patient?s disease progresses, whichever comes first. The study doctors hope to learn if adding ibrutinib to the usual treatment of methotrexate and rituximab will increase the number of patients whose cancer does not worsen after one year.

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Disease Site	Trial Code	Patients Accrued	Patients - Blocks	Patients - Slides	Patients - Blocks and/or Slides
IND	I244	Open Trial	0	1	1

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(Core size is 0.6 mm)

Disease Site	Trial Code	Patients Accrued	TMA Blocks	Patients on TMA Blocks
IND	I244	Open Trial	0	0

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Disease Site	Trial Code	Patients Accrued	Patients - Whole Blood	Patients - Cellular Component of Blood	Patients - DNA extracted from Blood	Patients - RNA extracted from Blood	Patients - Plasma	Patients - Serum	Patients - Urine	Patients - Buccal
IND	I244	Open Trial	2	0	0	0	2	0	0	0