Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06045247
Phase
PHASE2
Status
Recruiting
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Conditions

  • Large B-cell Lymphoma

Eligibility Criteria

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

Interventions

  • Prednisone — DRUG
    Given by IV (vein)
  • Rituximab — DRUG
    Given by IV (vein)
  • Cyclophosphamide — DRUG
    Given by IV (vein)
  • Vincristine — DRUG
    Given by IV (vein)
  • Epcoritamab — DRUG
    Given under the skin

Study Details

To learn if adding epcoritamab to the treatment combination R-miniCVP (rituximab, cyclophosphamide, vincristine, prednisone) can help to control newly diagnosed DLBCL. The safety of this combination will also be studied.

Key Dates

Start date
Jan 5, 2024
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2030

Study Design

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

Arms

  • Experimental: R-miniCVP+ Epcoritamab
    Starting on Day 1 of Cycle 2, you will also receive epcoritamab 1 time each week (Days 1, 8, 15, and 22 of each cycle). Epcoritamab is given as an injection under your skin, after you complete your dose of R-miniCVP. You may receive up to 6 cycles of R-miniCVP (Cycles 1-6) and up to 11 cycles of epcoritamab (Cycles 2-12), depending on how the disease responds to treatment.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion: an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Dai Chihara, M D
[email protected]
713-792-2860
Dai Chihara, M D (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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