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โ† Trials
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IGNITE: Study of Tirabrutinib vs Rituximab and Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)

RecruitingPhase 3Ages 18 Years - anyAllOno Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria 1. Pathology report confirming the diagnosis of B-cell 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 measurable brain lesions with a diameter in at least one dimension greater than or equal to (โ‰ฅ) 1 centimeter (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 isolated intraocular PCNSL or spinal 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 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
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What it tests

  • Tirabrutinib
  • Rituximab
  • Temozolomide
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Where

38 sites
Mayo Clinic Cancer Center
Phoenix, United States
HonorHealth Cancer Center
Scottsdale, United States
Providence Medical Foundation
Fullerton, United States
UC Irvine Health
Orange, United States
Yale Cancer Center
New Haven, United States
John Hopkins University
Washington D.C., United States
University of Florida Gainesville
Gainesville, United States
Mayo Clinic Cancer Center
Jacksonville, United States

โ€ฆand 30 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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