Epcoritamab in Combination With R-CHOP for Patients With Aggressive Non-Hodgkin Lymphoma

Part of paid clinical trials in San Francisco, California.

Sponsor
Mwanasha Merrill, MD
Study ID
NCT07588698
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Lymphoma Non-Hodgkin
  • Non-Hodgkin's B-cell Lymphoma

Eligibility Criteria

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

Interventions

  • Rituximab, Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisolone (R-CHOP) — DRUG
    Given orally and intravenously (IV)
  • Epcoritamab — DRUG
    Given subcutaneously (SC)
  • Dexamethasone — DRUG
    Given orally
  • Positron Emission Tomography (PET) — PROCEDURE
    Undergo imaging
  • Blood specimen collection — PROCEDURE
    Perform Blood work
  • Questionnaires — BEHAVIORAL
    Participants complete European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
  • Computerized tomography (CT) — PROCEDURE
    Undergo Imaging

Study Details

A Phase II, open-label, two-arm, multicenter study evaluating the combination of epcoritamab with R-CHOP chemotherapy in patients with newly diagnosed, aggressive B-cell non-Hodgkin lymphoma.

Key Dates

Start date
Jul 15, 2026
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Treatment with Standard Dexamethasone (First 6 participants)
    Participants will receive 8 cycles of rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin, prednisolone (R-CHOP) chemotherapy combined with epcoritamab. A standard dose of dexamethasone is given in Cycle 2. Treatment includes six 21-day cycles: Cycle 1 consists of R-CHOP alone; Cycles 2-5 include R-CHOP on Day 1 with epcoritamab on Days 1, 8, and 15. In Cycle 2, dexamethasone is given on epcoritamab treatment days and for 3 subsequent days. In Cycle 6, both R-CHOP and epcoritamab are given on Day 1 only. This is followed by two 28-day consolidation cycles (Cycles 7-8) with epcoritamab on Day 1. Safety follow-up occurs at Week 8 and every 3 months for up to one year. Participants who discontinue due to adverse events will be followed until improvement or stabilization, or until new therapy begins, whichever occurs first.
  • Experimental: Arm B: Treatment with Modified Dexamethasone
    Participants will receive 8 cycles of rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin, prednisolone (R-CHOP) chemotherapy combined with epcoritamab. A modified dose of dexamethasone will be given in Cycle 2. Treatment includes six 21-day cycles: Cycle 1 consists of R-CHOP alone; Cycles 2-5 include R-CHOP on Day 1 with epcoritamab on Days 1, 8, and 15. In Cycle 2, dexamethasone is administered on epcoritamab treatment days and the following day. In Cycle 6, both R-CHOP and epcoritamab are given on Day 1 only. This is followed by two 28-day consolidation cycles (Cycles 7-8) with epcoritamab on Day 1. Safety follow-up occurs at Week 8 and every 3 months for up to one year. Participants who discontinue due to adverse events will be followed until improvement or stabilization, or until new therapy begins, whichever occurs first.

Primary Outcome Measure

Cytokine Release Syndrome (CRS) Rate [ Time Frame: Up to day 42 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
UCSF Hematopoietic Malignancies Clinical Trial Recruitment
[email protected]
877-827-3222
[email protected]
Mwanasha Merrill, MD (PRINCIPAL_INVESTIGATOR)
Zuckerberg San Francisco GeneralSan FranciscoCalifornia94110
UCSF Hematopoietic Malignancies Clinical Trial Recruitment
[email protected]
877-827-3222
Clinical Trial Recruitment
[email protected]
Mwanasha Merrill, MD (PRINCIPAL_INVESTIGATOR)

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