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NCT05681195 · ClinicalTrials.gov registry record · Phase 2
Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas
A Phase 2 study of Refractory Cancer and Primary Central Nervous System Lymphoma, sponsored by Baptist Health South Florida.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05681195: Recruiting Phase 2 study of Refractory Cancer and Primary Central Nervous System Lymphoma, sponsored by Baptist Health South Florida.
NCT05681195 is a Phase 2 study of Refractory Cancer and Primary Central Nervous System Lymphoma that is actively recruiting participants, run by Baptist Health South Florida. The registered enrollment target is 15 participants, below the 129-participant average among 15 other Refractory Cancer trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05681195, a Phase 2 study of Refractory Cancer and Primary Central Nervous System Lymphoma, is actively recruiting participants, sponsored by Baptist Health South Florida.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being conducted to evaluate the safety and efficacy of the combination of pemetrexed and zanubrutinib (called induction therapy) followed by zanubrutinib treatment alone (also called maintenance therapy) in people who have relapsed or refractory (RR) primary central nervous system lymphoma (PCNSL) or isolated central nervous system relapse of B cell lymphoma (SCNSL). Assessments include how well people respond to this treatment, whether their disease gets better or worse, and their survival. Safety of this treatment and its side effects also will be assessed.
Primary Outcome
Best ORR to induction therapy is defined as the best response between the start of induction therapy until the end of induction therapy based on the criteria set forth in "Report of an international workshop to standardize baseline evaluation and response criteria for primary CNS lymphoma" (2005).
Conditions Studied
Interventions
- DRUG Zanubrutinib
- DRUG Pemetrexed
- PROCEDURE Autologous Stem Cell Transplant (ASCT)
- RADIATION Whole Brain Radiation Therapy (WBRT)
Study Locations (1)
Florida
- Miami Cancer Institute at Baptist Health, Inc. - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-04-25 |
| Est. Completion | 2033-02 |
| Phase | Phase 2 |
What NCT05681195 shows while recruiting
NCT05681195 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 129-participant average among 15 other Refractory Cancer trials with a reported enrollment target (88% lower).
The record links to 4 conditions, with Refractory Cancer appearing as the primary indexed condition, and to 4 interventions - of which Zanubrutinib is the first listed.
NCT05681195 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05681195 about?
NCT05681195 is a clinical study titled "Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas". This study is being conducted to evaluate the safety and efficacy of the combination of pemetrexed and zanubrutinib (called induction therapy) followed by zanubrutinib treatment alone (also called maintenance therapy) in people who have relapsed or refractory (RR) primary central nervous system lymp...
What is the current status of trial NCT05681195?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2024-04-25. Estimated completion is 2033-02.
What conditions does trial NCT05681195 study?
This clinical trial studies the following conditions: Refractory Cancer, Primary Central Nervous System Lymphoma, Relapsed Cancer, Secondary Central Nervous System Lymphoma.
What interventions are being tested in trial NCT05681195?
The interventions under investigation include: Zanubrutinib (DRUG), Pemetrexed (DRUG), Autologous Stem Cell Transplant (ASCT) (PROCEDURE), Whole Brain Radiation Therapy (WBRT) (RADIATION).
Who is sponsoring clinical trial NCT05681195?
This trial is sponsored by Baptist Health South Florida, which has 40 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05681195 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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