A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
Genmab
Study ID
NCT06508658
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Epcoritamab — DRUG
    Subcutaneous Injection
  • Rituximab — DRUG
    Intravenous (IV) Infusion
  • Lenalidomide — DRUG
    Oral Capsule
  • Oxaliplatin — DRUG
    IV Infusion
  • Gemcitabine — DRUG
    IV Infusion

Study Details

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective epcoritamab plus lenalidomide (E-Len) is compared to rituximab plus gemcitabine and oxaliplatin (R-GemOx) )in treating adult participants with relapsed or refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL). Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 360 adult participants with R/R DLBCL will be enrolled in approximately 165 sites across the world. Participants in arm A will receive subcutaneous (SC) injections of epcoritamab plus oral lenalidomide capsules (E-Len) for up to 12 cycles (each cycle is 28 days). Participants in arm B will receive intravenously (IV) infused R-GemOx for up to 4 cycles (each cycle is 28 days). Participants in arm C will receive SC injections of epcoritamab for up to 12 cycles (each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Key Dates

Start date
Aug 13, 2024
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

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

Arms

  • Experimental: Arm A: Epcoritamab Plus Lenalidomide (E-Len)
    Participants will receive E-Len for up to 12 cycles (each cycle is 28 days).
  • Experimental: Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx)
    Participants will receive R-GemOx for up to 4 cycles (each cycle is 28 days)
  • Experimental: Arm C: Epcoritamab
    Participants will receive epcoritamab for up to 12 cycles (each cycle is 28 days).

Primary Outcome Measure

Arm A vs Arm B: Progression-Free Survival (PFS) [ Time Frame: Up to 4 Years ]

Locations (19)

FacilityCityStateZIPSite coordinators
City of Hope National Medical Center /ID# 273338DuarteCalifornia91010-
Valkyrie Clinical Trials /ID# 269935Los AngelesCalifornia90067-
Desert Regional Medical Center /ID# 272437Palm SpringsCalifornia92262-
Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823GoldenColorado80401-
City Of Hope - Atlanta. /ID# 273092NewnanGeorgia30265-
Rush University Medical Center /ID# 242103ChicagoIllinois60612-
City Of Hope - Chicago /ID# 274430ZionIllinois60099-
Northwest Cancer Center - Dyer Clinic /ID# 269787DyerIndiana46311-
Cancer Center of Kansas - Wichita /ID# 270117WichitaKansas67214-
University of Kentucky Chandler Medical Center. /ID# 242087LexingtonKentucky40536-
University of Maryland, Baltimore /ID# 242216BaltimoreMaryland21201-
Henry Ford Hospital /ID# 266446DetroitMichigan48202-
Gulfport Memorial Hospital /ID# 268104GulfportMississippi39501-
New York Medical College /ID# 265799ValhallaNew York10595-
East Carolina University - Brody School of Medicine /ID# 242227GreenvilleNorth Carolina27834-
Thompson Cancer Survival Ctr /ID# 242149KnoxvilleTennessee37916-
Community Cancer Trials Of Utah /ID# 271715OgdenUtah84405-
Utah Cancer Specialists - Salt Lake City /ID# 268603Salt Lake CityUtah84106-
Veterans Affairs Medical Center - Salt Lake City /ID# 265329Salt Lake CityUtah84108-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAValkyrie Clinical Trials· Los Angeles, CADesert Regional Medical Center· Palm Springs, CALutheran Medical Center- Cancer Centers of Colorado· Golden, COCity Of Hope - Atlanta.· Newnan, GARush University Medical Center· Chicago, IL

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