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NCT04548648 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas
A Phase 2 study of Central Nervous System Lymphoma, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 3
- Study locations
NCT04548648: Active Phase 2 study of Central Nervous System Lymphoma, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT04548648 is a Phase 2 study of Central Nervous System Lymphoma that is active but no longer recruiting, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 10 participants, below the 105-participant average among 14 other Central Nervous System Lymphoma trials with a reported enrollment target (90% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04548648, a Phase 2 study of Central Nervous System Lymphoma, is active but no longer recruiting, sponsored by UNC Lineberger Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to test whether giving acalabrutinib is safe and effective in controlling relapsed central nervous system (CNS) lymphoma. Currently, there are no FDA-approved treatments for relapsed CNS lymphoma. Although acalabrutinib has not been approved for the treatment of CNS lymphoma, it was approved for the treatment of another type of lymphoma (mantle cell), by the Food and Drug Administration (FDA). Acalabrutinib acts similar to another cancer drug called ibrutinib. lbrutinib was tested in several research trials for the management of CNS lymphomas, and the results were promising. Acalabrutinib and ibrutinib attack a similar target found in CNS lymphoma. Acalabrutinib may do a better job in attacking this target than ibrutinib. The study doctors will be looking to see if acalabrutinib can shrink cancer cells.
Primary Outcome
The overall response rate (ORR) will be assessed based on the International Primary CNS Lymphoma Collaborative Group Response assessment criteria. Responder = Partial Response + Complete Response). Complete response (CR) as complete disappearance of contrast enhancement on magnetic resonance imaging (MRI), no evidence of ocular lymphoma, negative cerebrospinal fluid (CSF) cytology, and discontinuation of corticosteroid use for at least 2 weeks prior to the evaluation of response. Unconfirmed CR
Conditions Studied
Interventions
- DRUG Acalabrutinib
Study Locations (3)
North Carolina
- Lineberger Comprehensive Cancer Center - Chapel Hill
- Wake Forest University,The Atrium Health Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem
Florida
- Moffit Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-10-15 |
| Est. Completion | 2030-03-14 |
| Phase | Phase 2 |
What the registry record for NCT04548648 still lists
NCT04548648 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 105-participant average among 14 other Central Nervous System Lymphoma trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Central Nervous System Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Acalabrutinib is the first listed.
NCT04548648 reports a single indexed study location in North Carolina, Florida.
Frequently Asked Questions
What is clinical trial NCT04548648 about?
NCT04548648 is a clinical study titled "A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas". The purpose of this study is to test whether giving acalabrutinib is safe and effective in controlling relapsed central nervous system (CNS) lymphoma. Currently, there are no FDA-approved treatments for relapsed CNS lymphoma. Although acalabrutinib has not been approved for the treatment of CNS lymp...
What is the current status of trial NCT04548648?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2020-10-15. Estimated completion is 2030-03-14.
What conditions does trial NCT04548648 study?
This clinical trial studies the following conditions: Central Nervous System Lymphoma.
What interventions are being tested in trial NCT04548648?
The interventions under investigation include: Acalabrutinib (DRUG).
Who is sponsoring clinical trial NCT04548648?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04548648 being conducted?
This trial has 3 study locations across Florida, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04548648's enrollment target sits among peer trials
10 15th of 14 the lowest of 14 other Central Nervous System Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Central Nervous System Lymphoma 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.
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