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

NCT07104032

RecruitingPhase 3

Sponsor: Ono Pharmaceutical Co., Ltd.

Conditions: Relapsed/Refractory Primary Central Nervous System Lymphoma

Interventions: Tirabrutinib, Rituximab, Temozolomide

Countries: United States, Australia, Czechia, France, Italy, Spain

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 bi-dimensionally measurable brain lesions with a minimum diameter greater than or equal to (≥)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 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

Locations (32)

Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Fullerton, California, United States
Orange, California, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
Hackensack, New Jersey, United States
Summit, New Jersey, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Portland, Oregon, United States
Hershey, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Melbourne, Victoria, Australia
Ostrava, Czechia, Czechia
Prague, Czechia, Czechia
Marseille, France, France
Montpellier, France, France
Brescia, Italy, Italy
Meldola, Italy, Italy
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