Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Waukesha, Wisconsin.

Sponsor
Genmab
Study ID
NCT05660967
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Epcoritamab — BIOLOGICAL
    Epcoritamab will be administered by subcutaneous (SC) injections in 28-day cycles for up to 12 cycles.
  • Lenalidomide — DRUG
    Lenalidomide will be administered orally (capsules; starting dose of 10 or 20 mg) once daily on Day 1 to Day 21 of each 28-day cycle for up to 12 cycles.

Study Details

The purpose of the study is to examine efficacy and safety of epcoritamab with and without lenalidomide in newly diagnosed elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) who cannot tolerate anthracycline therapy. Epcoritamab (also known as EPKINLY™, GEN3013 and DuoBody®-CD3xCD20) is an antibody that has already been tested in several clinical studies. All patients will receive active treatment. There is an equal chance of receiving epcoritamab or epcoritamab plus lenalidomide.

Key Dates

Start date
Mar 6, 2023
Status verified
Jun 2026
Primary completion
Jun 14, 2026
Completion
Jun 28, 2026

Study Design

Enrollment
111 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Epcoritamab monotherapy
  • Experimental: Epcoritamab in combination with lenalidomide

Primary Outcome Measure

Complete Response (CR) rate [ Time Frame: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
UW Cancer Center at ProHealth CareWaukeshaWisconsin53188-

Find similar trials in Waukesha, WI

By research site
UW Cancer Center at ProHealth Care· Waukesha, WI

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