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

Part of paid clinical trials in Miami, Florida.

Sponsor
Baptist Health South Florida
Study ID
NCT05681195
Phase
PHASE2
Status
Recruiting
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Conditions

  • Primary Central Nervous System Lymphoma
  • Refractory Cancer
  • Relapsed Cancer
  • Secondary Central Nervous System Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pemetrexed — DRUG
    Participants will receive 900 mg/m\^2 via IV infusion over 10 minutes every 3 weeks x 4-8 induction cycles (21 days per cycle) as part of the induction therapy.
  • Zanubrutinib — DRUG
    Participants will receive 320 mg PO daily or dose-adjusted when given concomitantly with CYP3A4 inhibitor on Days 3-19 of each induction cycle x 4-8 cycles (21 days per cycle) as part of the induction therapy. For those on maintenance therapy, participants will receive 320 mg PO daily or dose-adjusted when given concomitantly with CYP3A4 inhibitor on Days 1-28 of each maintenance cycle (28 days per cycle) until the transplant (if applicable) or disease progression.
  • Autologous Stem Cell Transplant (ASCT) — PROCEDURE
    ASCT will occur in participants who are candidates for this procedure according to standard of care institutional protocols
  • Whole Brain Radiation Therapy (WBRT) — RADIATION
    WBRT will occur in participants who are candidates for this procedure but not candidates for ASCT according to standard of care institutional protocols

Study Details

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.

Key Dates

Start date
Apr 25, 2024
Status verified
Mar 2026
Primary completion
Feb 29, 2028
Completion
Feb 28, 2033

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Induction Therapy + SOC Treatment
    Participants will receive the induction therapy (oral zanubrutinib + IV pemetrexed) and be placed into one of the cohorts according to standard of care (SOC) treatment: Cohort 1: Induction Therapy + Autologous Stem Cell Transplant (ASCT) After completion of the induction therapy, ASCT candidates will undergo transplant as per SOC. If the transplant is delayed and 8 induction cycles have been completed, oral zanubrutinib maintenance will proceed until transplant, but will not occur after transplant. Cohort 2: Induction Therapy + Whole Brain Radiation Therapy (WBRT) After completion of the induction therapy, WBRT candidates will undergo WBRT as per SOC. Oral zanubrutinib maintenance will start 7-10 days after the completion of WBRT. 28-d maintenance cycles will continue until disease progression. Cohort 3: Induction Therapy Alone After completion of the induction therapy, 28-day oral zanubrutinib maintenance cycles will begin and continue until disease progression

Primary Outcome Measure

Best Overall Response Rate (ORR) to Induction Therapy [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Miami Cancer Institute at Baptist Health, Inc.MiamiFlorida33176
Yuliya Linhares, M.D.
[email protected]
786-596-2000

Find similar trials in Miami, FL

By research site
Miami Cancer Institute at Baptist Health, Inc.· Miami, FL

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