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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523389-26-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Deciphera Pharmaceuticals, LLC | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirabrutinib | Experimental | Tirabrutinib 480 milligram (mg) orally every day (QD), as monotherapy in 28-day cycles. |
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| Rituximab-Temozolomide (R-TMZ) | Active Comparator | Rituximab 375 milligram per square meter (mg/m2) intravenously (IV) and temozolomide 150 mg/m2/day orally, as combination therapy for Cycle 1 through 6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirabrutinib | Drug | Administered orally. |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS based on blinded Independent Review Committee (BIRC) assessment according to International Primary Central Nervous System Lymphoma Collaborative Group (IPCG) criteria, defined as time from randomization to progressive disease (PD) or death due to any cause, whichever occurs first. | Estimated up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR based on BIRC per IPCG criteria, defined as the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR). | Estimated up to 48 months] |
| Overall Survival (OS) |
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Inclusion 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:
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
Exclusion Criteria
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Team | Contact | 888-724-3274 | clinicaltrials@deciphera.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Team | Deciphera Pharmaceuticals, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Cancer Center | Recruiting | Phoenix | Arizona | 85054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42317052 | Derived | Nayak L, Grommes C, Psoinos C, Reu FJ, Takazawa A, Uttarwar M, Xia B, Carvajal LA, Kim S, Sherman ML, Batchelor TT. IGNITE: a phase III study of tirabrutinib versus rituximab and temozolomide combination therapy in relapsed/refractory primary central nervous system lymphoma. Future Oncol. 2026 Jun 19:1-7. doi: 10.1080/14796694.2026.2683574. Online ahead of print. |
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| Rituximab | Drug | Administered intravenously (IV). |
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| Temozolomide | Drug | Administered orally. |
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OS defined as time from randomization until death due to any cause. |
| Estimated up to 48 months |
| Complete Response Rate (CRR) | CRR based on BIRC per IPCG criteria, defined as the percentage of participants with a best overall response of CR or CRu. | Estimated up to 48 months |
| Best Overall Response (BOR) | BOR based on BIRC per IPCG criteria, defined as the best response from randomization to the date of PD or the date of initiation of subsequent anticancer therapy for PCNSL, whichever occurs first. | Estimated up to 48 months] |
| Time to Response (TTR) | TTR based on BIRC per IPCG criteria, defined as time between randomization and the date of first response of CR, CRu, or PR. | Estimated up to 48 months |
| Time to Complete Response (TTCR) | TTCR based on BIRC per IPCG criteria, defined as the time between randomization and the date of first complete response (CR or CRu). | Estimated up to 48 months |
| Duration of Response (DOR) | DOR based on BIRC per IPCG criteria, defined as the time between the date of first response (CR, CRu, or PR) and the date of the first PD or date of death due to any cause, whichever occurs first. | Estimated up to 48 months |
| Disease Free Survival (DFS) | DFS based on BIRC per IPCG criteria, defined as the time between the date of first complete response (CR or CRu) and the date of the first PD, or date of death due to any cause, whichever occurs first. | Estimated up to 48 months |
| Change from Baseline in Corticosteroid Dose | Baseline, estimated up to 48 months |
| HonorHealth Cancer Center | Recruiting | Scottsdale | Arizona | 85251 | United States |
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| Providence Medical Foundation | Recruiting | Fullerton | California | 92835 | United States |
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| UC Irvine Health | Recruiting | Orange | California | 92868 | United States |
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| Yale Cancer Center | Recruiting | New Haven | Connecticut | 06520 | United States |
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| John Hopkins University | Recruiting | Washington D.C. | District of Columbia | 20016 | United States |
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| Mayo Clinic Cancer Center | Recruiting | Jacksonville | Florida | 32224 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Mayo Clinic Cancer Center | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Atlantic Health Overlook Medical Center | Recruiting | Summit | New Jersey | 07901 | United States |
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| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| Providence Neurological Specialties West | Recruiting | Portland | Oregon | 97225 | United States |
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| UPMC Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
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| Rhode Island Hospital | Recruiting | Providence | Rhode Island | 02903 | United States |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000608238 | tirabrutinib |
| D000069283 | Rituximab |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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