Outpatient Epcoritamab in Large B-cell Lymphoma

Conditions

• Refractory Large B-cell Lymphoma
• Relapsed Large B-cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Epcoritamab — DRUG
  Bispecific IgG1 antibody
• Rituximab combined with cyclophosphamide, vincristine, and prednisone — DRUG
  Epco-R-CVP
• Rituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisone — DRUG
  Epco-R-CHOP
• Rituximab combined with polatuzumab, cyclophosphamide, doxorubicin, and prednisone — DRUG
  Epco-pola-R-CHP

Study Details

The purpose of this study is to measure the efficacy of the study drug, epcoritamab, in participants with relapsed/refractory large B-cell lymphoma.

Key Dates

First listed

Feb 6, 2025

Start date

Jun 5, 2025

Status verified

Jul 2026

Primary completion

Oct 1, 2026

Completion

Oct 1, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: First Line
  Epcoritamab will be given as monotherapy on EPCO cycles 1 days 1, 8, 15, and 22, EPCO cycles 2 days 1, 8, 15, and 22, EPCO cycles 3-4 days 1 and 15, and EPCO cycles 3-8 days 1 and 15 as an injection under your skin (subcutaneous injection). Epcoritamab will be given with chemotherapy through the vein with steroid pills (prednisone) on EPCO-CHEMO cycles 1-4 day 1 and EPCO-CHEMO cycles 1-6 day 1 based on tumor response. There are three different chemotherapy regimens which are Epco-R-CVP, Epco-R-CHOP, and Epco-pola-R-CHP. Epco-R-CVP consists of epcoritamab, rituximab, cyclophosphamide, vincristine, and prednisone. Epco-R-CHOP consists of epcoritamab, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. Epco-pola-R-CHP consist of epcoritamab, polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone. You will receive dexamethasone which may provide relief for areas of the body that are inflamed during study treatment.
• Experimental: Second Line
  Epcoritamab will be given as an injection under the skin (subcutaneous injection) on cycle 1-3 days 1, 8, 15, and 22, cycle 4-9 days 1 and 15, and cycle 10 and onwards day 1. You will receive dexamethasone which may provide relief for areas of the body that are inflamed during study treatment.

Primary Outcome Measure

Complete Response Rate (CRR) in first line cohort [ Time Frame: Day 1 until date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 12 months after initial dose of study treatment. ]

Central Contacts

• Julie E. Haydu, MD, PhD
  617-724-4000
  [email protected]

Locations (2)

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