Trial comparing treatments for Relapsed/Refractory Primary Central Nervous System Lymphoma
Official title IGNITE: Study of Tirabrutinib vs Rituximab and Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
ClinicalTrials.gov ID: NCT07104032
What this study is testing
What is Tirabrutinib?
An investigational oral medicine being studied for relapsed or refractory primary central nervous system lymphoma. It is designed to inhibit BTK, a protein involved in B‑cell signaling.
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 study compares how well tirabrutinib alone works versus a combo of rituximab and temozolomide in treating relapsed or refractory primary brain lymphoma.
- Who it's for
- Adults with relapsed or refractory primary central nervous system lymphoma.
- What's involved
- Participants will receive either tirabrutinib or the rituximab‑temozolomide combination, with regular clinic visits and medical tests to monitor response and side effects.
- Time commitment
- The trial lasts several months, with scheduled visits for medication, blood work, imaging, and safety checks.
- 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 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 measurable brain lesions with a diameter in at least one dimension greater than or equal to (≥) 1 centimeter (cm) in gadolinium-enhanced...
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
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
- 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
See the full eligibility criteria
- Pathology report confirming the diagnosis of B-cell 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 measurable brain lesions with a diameter in at least one dimension greater than or equal to (≥) 1 centimeter (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
- 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 is enrolling
- 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
- Rochester, Minnesota, United States
- Hackensack, New Jersey, United States
- Summit, New Jersey, United States
- New York, New York, United States
- Rochester, New York, United States
- Durham, North Carolina, United States
- Portland, Oregon, United States
- Hershey, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
+ 16 more site(s).
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, but 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?
This study is enrolling now at 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 30 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.