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Compares treatment options for Relapsed/Refractory Primary Central Nervous System Lymphoma
Official title IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
ClinicalTrials.gov ID: NCT07104032
What this study is testing
What is Tirabrutinib?
Tirabrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for relapsed/refractory primary central nervous system lymphoma.
Also referred to as ONO-4059.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathology report confirming the diagnosis of B-cell PCNSL
- 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.
- One or more bi-dimensionally measurable brain lesions with a minimum diameter greater than or equal to (≥)1 centimeter (cm) × ≥1 cm in...
You likely can't join if
- Participants with isolated intraocular PCNSL or spinal PCNSL with no brain lesions
- Participants with non-B-cell PCNSL
- Participants with systemic presence of lymphoma
- Refractory to temozolomide with or without rituximab-containing regimens in the last PCNSL treatment
- Concomitant systemic corticosteroid exposure within 14 days before starting study drug per Investigator assessment with the exception of the...
- Equivalent of up to 10 milligram per day (mg/day) of prednisone for a disease other than PCNSL
See the full eligibility criteria
- Pathology report confirming the diagnosis of B-cell PCNSL
- 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.
- 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)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
- Adequate bone marrow, renal, and hepatic function per central lab values
- Participants must agree to comply with all defined contraceptive requirements
- Participants with isolated intraocular PCNSL or spinal PCNSL with no brain lesions
- Participants with non-B-cell PCNSL
- Participants with systemic presence of lymphoma
- Refractory to temozolomide with or without rituximab-containing regimens in the last PCNSL treatment
- 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
- Active malignancy, other than PCNSL requiring systemic therapy
- Poorly controlled comorbidity, or history of medical conditions contraindicated per Investigator assessment
- Participants who are unable to swallow oral medication
- Prior Bruton's tyrosine kinase inhibitor treatment
The study team makes the final eligibility decision.
Where it's taking place
- 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
- Jacksonville, Florida, 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
- Durham, North Carolina, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.