RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Quick Facts

Study Start:2024-08-13
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06508658

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eastern Cooperative Oncology Group Performance status score of 0 to 2.
  2. * Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documented in the most recent and representative pathology report, inclusive of the following according to the World Health Organization (WHO) 2022 as per the protocol.
  3. * Must have relapsed or refractory (R/R) disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis.
  4. * Participant must meet at least 1 of the following criteria:
  5. * Failed prior autologous stem cell transplant (ASCT), defined as relapsed after ASCT or been refractory to high-dose therapy (HDT)-ASCT.
  6. * Not be considered a candidate for ASCT due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT.
  7. * Be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) meeting at least 1 of the following criteria:
  8. * Unable to receive CAR-T therapy due to fitness and/or comorbidity.
  9. * Lymphocyte apheresis failure.
  10. * Unwilling to receive CAR-T therapy.
  11. * Unable to receive CAR-T therapy due to financial, geographic, insurance, access, and/or manufacturing constraints.
  12. * Relapsed/progressed after having achieved at least a Partial Response (PR) or Complete Response (CR) while on prior CAR-T therapy.
  13. * Must have measurable disease.
  14. * Life expectancy \> 3 months on standard of care treatment at the time of enrolling in the study
  1. * Current evidence of primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening.
  2. * History of prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with rituximab plus gemcitabine and oxaliplatin (R-GemOx) or gemcitabine and oxaliplatin (GemOx).
  3. * Documented refractoriness to lenalidomide.

Contacts and Locations

Study Contact

ABBVIE CALL CENTER
CONTACT
844-663-3742
abbvieclinicaltrials@abbvie.com

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

Valkyrie Clinical Trials /ID# 269935
Los Angeles, California, 90067
United States
Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823
Golden, Colorado, 80401
United States
Northwest Cancer Center - Dyer Clinic /ID# 269787
Dyer, Indiana, 46311
United States
Cancer Center of Kansas - Wichita /ID# 270117
Wichita, Kansas, 67214
United States
University of Kentucky Chandler Medical Center /ID# 242087
Lexington, Kentucky, 40536
United States
University of Maryland, Baltimore /ID# 242216
Baltimore, Maryland, 21201
United States
Gulfport Memorial Hospital /ID# 268104
Gulfport, Mississippi, 39501
United States
New York Medical College /ID# 265799
Valhalla, New York, 10595
United States
Thompson Cancer Survival Ctr /ID# 242149
Knoxville, Tennessee, 37916
United States
Community Cancer Trials Of Utah /ID# 271715
Ogden, Utah, 84405
United States
Utah Cancer Specialists - Salt Lake City /ID# 268603
Salt Lake City, Utah, 84106
United States
Veterans Affairs Medical Center - Salt Lake City /ID# 265329
Salt Lake City, Utah, 84108
United States

Collaborators and Investigators

Sponsor: Genmab

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-13
Study Completion Date2028-01

Study Record Updates

Study Start Date2024-08-13
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • Epcoritamab
  • Lenalidomide
  • Rituximab
  • Gemcitabine
  • Oxaliplatin
  • Diffuse Large B-Cell Lymphoma
  • DLBCL
  • Epkinly
  • ABBV-GMAB-3013

Additional Relevant MeSH Terms

  • Diffuse Large B-Cell Lymphoma