Epco, Zanu, Ritux for R/R FL or MZL

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Reid Merryman, MD
Study ID
NCT06563596
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Zanubrutinib — DRUG
    Bruton tyrosine kinase inhibitor, 80 mg immediate-release capsule, taken orally per protocol.
  • Rituximab — DRUG
    Chimeric anti-CD20 monoclonal antibody, 10 or 50 mL single-use vials, via intravenous infusion per institutional standard.
  • Epcoritamab — DRUG
    Bispecific antibody, 5 or 60 mg/mL vials, via subcutaneous (under the skin) injection per protocol.

Study Details

The purpose of this study is to determine how effective and safe the combination of epcoritamab, zanubrutinib, and rituximab is in treating participants with relapse or refractory Follicular Lymphoma (FL) or marginal zone lymphoma (MZL). * The names of the study drugs involved in this research study are: * Epcoritamab (a type of antibody) * Zanubrutinib (a type of Bruton tyrosine kinase inhibitor) * Rituximab (a type of monoclonal antibody)

Key Dates

Start date
Jan 21, 2025
Status verified
Feb 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2030

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituxan + Zanubrutinib + Epcoritamab for FL
    Enrolled participants will complete: * Baseline visit with imaging and bone marrow biopsy * Imaging on cycles 3, 6, 9 * Up to 1 year of treatment with study drugs * End of Treatment visit with imaging and bone marrow biopsy * Follow up visits every 6 months for up to 10 years
  • Experimental: Rituxan + Zanubrutinib + Epcoritamab for MZL
    Enrolled participants will complete: * Baseline visit with imaging and bone marrow biopsy * Imaging on cycles 3, 6, 9 * Up to 1 year of treatment with study drugs * End of Treatment visit with imaging and bone marrow biopsy * Follow up visits every 6 months for up to 10 years

Primary Outcome Measure

Complete Metabolic Response (CMR) Rate among patients with R/R FL [ Time Frame: 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Reid Merryman, MD
[email protected]
617-632-6844
Reid Merryman, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021
Paola Ghione, MD
[email protected]
Paola Ghione, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Wexner Medical CenterColumbusOhio43210
Aubree Shoemaker
[email protected]
Yazeed Sawalha, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NYThe Ohio State University Wexner Medical Center· Columbus, OH

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