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Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas

StatusRecruiting
PhasePhase 2
Started2024-04-25
View on ClinicalTrials.gov ↗

Amendment history

2026-03-02
Study Status, Oversight, Contacts/Locations v9
Primary completion date2026-02→2028-02
Completion date2031-02→2033-02
Study sitescontacts updated at 1 of 1 site
2025-05-15
Study Status, Oversight, Outcome Measures, Eligibility, Contacts/Locations v8
Eligibility criteria+1,671 characters
[...] vious therapy or relapsed after initial successful treatment OR unable to tolerate previous therapy defined as Grade 3+ acute kidney injury (AKI) and/or transaminase elevation according to CTCAE v 5.0 criteria preventing repeat treatment exposure OR prior glucarpidase use due to high dose methotrexate delayed clearance and/or toxicity OR those who would have [...] No systemic lymphoma by positron emission tomography (PET) [...] documented Gilbert Syndrome Creatinine Clearance (CrCl)> 45 mlmL/minute using Cockcroft-Gault formula Ability to understand and sign written informed consent prior to study entry u [...] [...]
Secondary endpoints8 to 10 entries
Clinical benefit rate to induction therapy (pre-transplant, WBRT or zanubrutinib maintenance) Clinical benefit rate post-transplant, WBRT followed by zanubrutinib maintenance or zanubrutinib maintenance)
Study sitescontacts updated at 1 of 1 site
2024-05-03
Study Status, Sponsor/Collaborators v7
Start date2023-09-27→2024-04-25
Lead sponsorYuliya Linhares→Baptist Health South Florida
2024-04-04
Study Status, Sponsor/Collaborators v6
Lead sponsorBaptist Health South Florida→Yuliya Linhares
2023-10-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-09→confirmed 2023-09-27
Study sitesdetails revised at 1 of 1 site
Show 4 earlier versions
2023-08-07
Study Status v4
Primary completion date2025-12→2026-02
Completion date2030-12→2031-02
Start date2023-07→2023-09
2023-07-07
Study Status v3
Primary completion date2025-10→2025-12
Completion date2030-10→2030-12
Start date2023-05→2023-07
2023-03-29
Study Status v2
Primary completion date2025-09→2025-10
Completion date2030-09→2030-10
Start date2023-03→2023-05
2023-02-06
Study Status v1
Primary completion date2025-07→2025-09
Completion date2030-07→2030-09
Start date2023-01→2023-03
2022-12-23
Original filing
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.
Trial Details
NCT Number NCT05681195
Lead Sponsor Baptist Health South Florida
Collaborators: BeiGene
Conditions Primary Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma, Relapsed Cancer, Refractory Cancer
Enrollment 15 participants
Start Date 2024-04-25
Primary Completion 2028-02 (estimated)
Study Completion 2033-02 (estimated)
Updated on ClinicalTrials.gov 2026-03-03