Actively Recruiting
IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Led by Ono Pharmaceutical Co., Ltd. · Updated on 2026-05-13
132
Participants Needed
9
Research Sites
187 weeks
Total Duration
On this page
Sponsors
O
Ono Pharmaceutical Co., Ltd.
Lead Sponsor
D
Deciphera Pharmaceuticals, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathology report confirming diagnosis of B-cell PCNSL
- Relapsed or refractory B-cell PCNSL with at least 1 prior high-dose methotrexate-based therapy
- Relapsed disease defined by prior response and subsequent progression
- Refractory disease defined by stable disease or progression after last treatment
- One or more measurable brain lesions at least 1 cm in diameter on MRI
- ECOG Performance Status of 0 to 2
- Adequate bone marrow, kidney, and liver function based on lab tests
- Agreement to comply with all contraceptive requirements
You will not qualify if you...
- Isolated intraocular or spinal PCNSL without brain lesions
- Non-B-cell PCNSL
- Presence of lymphoma outside the central nervous system
- Refractory to temozolomide with or without rituximab-containing regimens in last treatment
- Use of systemic corticosteroids above defined limits within 14 days before study drug start
- Active non-PCNSL malignancy requiring systemic therapy
- Poorly controlled medical conditions or contraindications per investigator
- Inability to swallow oral medications
- Prior treatment with Bruton's tyrosine kinase inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
HonorHealth Cancer Center
Scottsdale, Arizona, United States, 85251
Actively Recruiting
2
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
3
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Actively Recruiting
6
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
9
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
C
Clinical Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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