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Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)
NCT04947319 · View on ClinicalTrials.gov ↗
Study Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B)
Conditions Studied
Interventions
- DRUG Tirabrutinib
Study Locations (20)
Florida
- Mayo Clinic- Jacksonville — Jacksonville
- University of Miami-Sylvester Cancer Center — Miami
- Orlando Health — Orlando
- Moffitt Cancer Center- Miami — Pembroke Pines
California
- City of Hope Comprehensive Breast Cancer Center — Duarte
- University of California, Irvine — Irvine
- Stanford University — Palo Alto
Massachusetts
- Massachusetts General Hospital — Boston
- Beth Israel Deaconess Medical Center — Boston
- Dana-Farber Cancer Institute - Brigham & Women's Hospital — Boston
Michigan
- University Of Michigan — Ann Arbor
- Henry Ford Hospital — Detroit
Alabama
- University of Alabama at Birmingham School of Medicine — Birmingham
Arizona
- Mayo Clinic- Phoenix — Phoenix
Colorado
- University of Colorado Denver — Aurora
Connecticut
- Yale Cancer Center — New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2021-12-29 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04947319
The ClinicalTrials.gov registry entry for NCT04947319 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ono Pharmaceutical Co., which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Refractory Primary Central Nervous System Lymphoma appearing as the primary indexed condition, and to 1 intervention — of which Tirabrutinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04947319 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04947319 about?
NCT04947319 is a clinical study titled "Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)". This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or rituximab/m...
What is the current status of trial NCT04947319?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 119 participants. The study started on 2021-12-29. Estimated completion is 2027-03-31.
What conditions does trial NCT04947319 study?
This clinical trial studies the following conditions: Refractory Primary Central Nervous System Lymphoma, Primary CNS Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04947319?
The interventions under investigation include: Tirabrutinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04947319?
This trial is sponsored by Ono Pharmaceutical Co., which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04947319 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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