Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPE… (NCT04947319) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)
United States119 participantsStarted 2021-12-29
Plain-language summary
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent by the patient prior to screening
✓. Patients aged ≥ 18 years on the day of consenting to the study
✓. Pathologic diagnosis of PCNSL
✓. Relapse or refractory PCNSL with at least one prior high dose methotrexate (HD-MTX) based therapy for PCNSL
✓. Measurable brain lesion with a minimum diameter \> 1.0 cm in gadolinium enhanced magnetic resonance imaging (MRI) performed within 14 days before starting tirabrutinib treatment
✓. Eastern Cooperative Oncology Group performance score (ECOG PS) of 0, 1 or 2
✓. Life expectancy of at least 3 months
✓. Adequate bone marrow, renal, and hepatic function
Exclusion criteria
✕. Intraocular PCNSL with no brain lesion
✕. Patient who is intolerant of contrast enhanced MRI due to allergic reactions to contrast agents
✕. Patient with non-B cell PCNSL
✕. Patient with systemic presence of lymphoma
✕. Prior chemotherapy within 21 days, nitrosourea within 42 days, an antibody drug with anticancer activity (e.g., rituximab) within 28 days, prior radiotherapy within 14 days, prior major invasive surgery within 28 days, or allogeneic stem cell transplant within 6 months before starting tirabrutinib treatment
What they're measuring
1
Overall response rate (ORR) (Part A)
Timeframe: 1 year
2
Tirabrutinib dose estimate (Part B)
Timeframe: 1 month
3
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during induction (Part B)
✕. Prior investigational drugs (including treatment in clinical research, unapproved combination products, and new dosage forms) within 28 days or 5 half-lives, whichever is shorter, before starting tirabrutinib treatment
✕. Concomitant systemic corticosteroid on an ongoing basis within 14 days before starting tirabrutinib treatment, with the exception of the following: