Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)

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Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)

Study Purpose

The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria. 1. Pathologically confirmed diagnosis of PCNSL. 2. Relapsed or refractory B-cell PCNSL with at least 1 prior high-dose methotrexate (HD-MTX) based therapy for PCNSL:

- Relapsed disease: Participants who achieved a response (CR, CRu, PR) to the last treatment and subsequently experienced disease progression.

- Refractory disease: Participants whose best response to the last treatment was stable disease or PD.

3. One or more bi-dimensionally measurable brain lesions with a minimum diameter greater than 1 centimeter (cm) × 1 cm in gadolinium-enhanced magnetic resonance imaging (MRI) 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2. 5. Adequate bone marrow, renal, and hepatic function per central lab values. 6. Participants must agree to comply with all defined contraceptive requirements.Exclusion Criteria. 1. Participants with intraocular PCNSL with no brain lesions. 2. Participants with non-B-cell PCNSL. 3. Participants with systemic presence of lymphoma. 4. Refractory to temozolomide with or without rituximab-containing regimens in the last PCNSL treatment. 5. Concomitant systemic corticosteroid exposure on an ongoing basis within 14 days before starting study drug per Investigator assessment with the exception of the following:

- Equivalent of up to 10 milligram per day (mg/day) of prednisone for a disease other than PCNSL.

- Equivalent of up to 50 mg/day of prednisone (equal to 8 mg/day dexamethasone) for participants with lesions of the brain and/or spinal cord.

6. Active malignancy, other than PCNSL requiring systemic therapy. 7. Poorly controlled comorbidity, or history of medical conditions contraindicated per Investigator assessment. 8. Participants who are unable to swallow oral medication. 9. Prior Bruton's tyrosine kinase inhibitor treatment

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07104032
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ono Pharmaceutical Co. Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Team
Principal Investigator Affiliation	Deciphera Pharmaceuticals, LLC
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsed/Refractory Primary Central Nervous System Lymphoma

Arms & Interventions

Arms

Experimental: Tirabrutinib

Tirabrutinib 480 milligram (mg) orally every day (QD), as monotherapy in 28-day cycles.

Active Comparator: Rituximab-Temozolomide (R-TMZ)

Rituximab 375 milligram per square meter (mg/m2) intravenously (IV) and temozolomide 150 mg/m2/day orally, as combination therapy for Cycle 1 through 6.