Comparing two treatments for relapsed or refractory diffuse large B-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of subcutaneously injected epcoritamab combined with oral lenalidomide against the intravenous administration of rituximab, gemcitabine, and oxaliplatin in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Approximately 320 participants will be enrolled across 165 sites globally, with participants assigned to one of two treatment arms. The study will monitor adverse events and changes in disease condition over a treatment period of up to 12 cycles, each lasting 28 days.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Eastern Cooperative Oncology Group Performance status score of 0 to 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.
* 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.
* . Participant must meet at least 1 of the following criteria:

  * Failed prior autologous stem cell transplant (ASCT), defined as relapsed after ASCT or been refractory to ASCT.
  * Not be considered a candidate for ASCT due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT.
  * Be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) meeting at least 1 of the following criteria:

    * Unable to receive CAR-T therapy due to fitness and/or comorbidity.
    * Lymphocyte apheresis failure.
    * Unwilling to receive CAR-T therapy.
    * Unable to receive CAR-T therapy due to financial, geographic, insurance, access, and/or manufacturing constraints.
    * Relapsed/progressed after having achieved at least a Partial Response (PR) or Complete Response (CR) while on prior CAR-T therapy.
* Must have measurable disease.
* Life expectancy \> 3 months on standard of care treatment at the time of enrolling in the study

Exclusion Criteria:

* Current evidence of primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening.
* 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).
* Documented refractoriness to lenalidomide.

Where it's running

• Valkyrie Clinical Trials /ID# 269935
  Los Angeles, California, United States Recruiting
• Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823
  Golden, Colorado, United States Recruiting
• Northwest Cancer Center - Dyer Clinic /ID# 269787
  Dyer, Indiana, United States Recruiting
• Cancer Center of Kansas - Wichita /ID# 270117
  Wichita, Kansas, United States Recruiting
• Gulfport Memorial Hospital /ID# 268104
  Gulfport, Mississippi, United States Recruiting
• New York Medical College /ID# 265799
  Valhalla, New York, United States Recruiting

+72 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

  This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.

  Recruiting Phase 4 The First Hospital of Jilin University · Changchun, Jilin · NCT07908888

• Glofitamab combo vs Rituximab combo with chemo for relapsed/refractory DLBCL

  This study tests whether glofitamab with chemotherapy (JS203-GemOx) helps patients with relapsed or refractory DLBCL more than rituximab with chemotherapy.

  Recruiting Phase 3 Shanghai Junshi Bioscience Co., Ltd. · Beijing, Beijing Municipality · NCT07808827

• Epcoritamab plus R-GemOx before autologous stem cell transplant for relapsed or refractory DLBCL

  This phase II trial tests whether adding epcoritamab to rituximab with gemcitabine and oxaliplatin (R-GemOx) can help adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) achieve remission and proceed to autologous stem cell transplant.

  Recruiting Phase 2 City of Hope Medical Center · Duarte, California and 2 other locations · NCT07365306

• Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL

  This trial tests whether giving allogeneic NK cells with Rituximab, Tafasitamab, and IL-2 can help people with relapsed or refractory B-cell non-Hodgkin lymphoma who have tried at least two prior therapies.

  Recruiting Phase 1 Case Comprehensive Cancer Center · Cleveland, Ohio and 1 other locations · NCT07225439

• Epcoritamab plus dose‑adjusted EPOCH‑R for aggressive B‑cell lymphoma

  This trial tests whether adding epcoritamab to dose‑adjusted EPOCH‑R chemotherapy can safely improve outcomes for adults with untreated aggressive B‑cell non‑Hodgkin lymphoma.

  Recruiting Phase 2 University of Washington · Seattle, Washington · NCT07097363

• Combining pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin for elderly diffuse large B‑cell lymphoma

  This tests whether adding polatuzumab vedotin to a pomalidomide, rituximab and orelabrutinib regimen helps patients aged 70 and older with newly diagnosed diffuse large B‑cell lymphoma.

  Recruiting The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07072208

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.