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NCT04947319 · ClinicalTrials.gov registry record · Phase 2
Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)
A Phase 2 study of Refractory Primary Central Nervous System Lymphoma and Primary CNS Lymphoma, sponsored by Ono Pharmaceutical Co..
- Active
- Registry status
- Phase 2
- Development phase
- 119
- Enrollment target
- 20
- Study locations
NCT04947319: Active Phase 2 study of Refractory Primary Central Nervous System Lymphoma and Primary CNS Lymphoma, sponsored by Ono Pharmaceutical Co..
NCT04947319 is a Phase 2 study of Refractory Primary Central Nervous System Lymphoma and Primary CNS Lymphoma that is active but no longer recruiting, run by Ono Pharmaceutical Co.. The registered enrollment target is 119 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04947319, a Phase 2 study of Refractory Primary Central Nervous System Lymphoma and Primary CNS Lymphoma, is active but no longer recruiting, sponsored by Ono Pharmaceutical Co..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 119 participants
- Enrollment target
- 20
- Study locations
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)
Primary Outcome
Overall response rate is defined as the proportion of patients with a best overall response of Complete response (CR), Complete response - unconfirmed (CRu), or (=partial response (PR) as determined by an independent review committee according to the International PCNSL Collaborative Group (IPCG) criteria.
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 |
What the registry record for NCT04947319 still lists
NCT04947319 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).
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.
NCT04947319 names 20 study sites across 12 states, led by Florida, California, Massachusetts.
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.
What interventions are being tested in trial NCT04947319?
The interventions under investigation include: Tirabrutinib (DRUG).
Who is sponsoring clinical trial NCT04947319?
This trial is sponsored by Ono Pharmaceutical Co., which has 17 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Refractory Primary Central Nervous System Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04947319's enrollment target sits among peer trials
119 618th of 2000 higher than 1,383 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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