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
M.D. Anderson Cancer Center
Summary
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.
Description
Primary Objectives: --To determine the efficacy of epcoritamab in combination with R-miniCVP as determined by CR rate after six cycles of combination treatment for elderly/unfit patients or patients with heart failure with previously untreated DLBCL. Secondary Objectives --To determine best overall response rate (ORR), duration of response, progression-free survival (PFS), overall survival (OS), and evaluation of safety of epcoritamab in combination with R-miniCVP as treatment for elderly/unfit patients or patients with heart failure with previously untreated DLBCL. Exploratory Objectives:…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patients must meet the following criteria for study entry: * Age ≥18 years * Histologically diagnosed * Diffuse large B-cell lymphoma, not otherwise specified (NOS) or * High grade B-cell lymphoma (NOS or MYC and BCL2 rearrangements) or * T cell/histiocyte-rich large B-cell lymphoma * Have no prior systemic treatment for current lymphoma * Ineligible for anthracycline-based cytotoxic chemotherapy due to one or more of the following: * Age ≥80 * Unfit/frail by simplified geriatric assessment4 * The link to calculate simplified geriatric assessment https://redcap.filinf.it/…
Interventions
- DrugPrednisone
Given by IV (vein)
- DrugRituximab
Given by IV (vein)
- DrugCyclophosphamide
Given by IV (vein)
- DrugVincristine
Given by IV (vein)
- DrugEpcoritamab
Given under the skin
Location
- M D Anderson Cancer CenterHouston, Texas