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 (NCT06508658) — China Trial Details

Condition(s) studied

Diffuse Large B-Cell Lymphoma

Investigational drug(s) / intervention(s)

EpcoritamabRituximabLenalidomideOxaliplatinGemcitabine

Epcoritamab: Subcutaneous Injection

Rituximab: Intravenous (IV) Infusion

Lenalidomide: Oral Capsule

Oxaliplatin: IV Infusion

Gemcitabine: IV Infusion

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

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 high-dose therapy (HDT)-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.

Primary outcome measure(s)

Arm A vs Arm B: Progression-Free Survival (PFS) — Up to 4 Years
PFS is defined as the duration from the date of randomization to the date of disease progression determined per Lugano 2014 criteria as assessed by an independent review committee (IRC), or death, whichever occurs first.

Trial sites (176)

Facility	City	Region
City of Hope National Medical Center /ID# 273338	Duarte	California
Valkyrie Clinical Trials /ID# 269935	Los Angeles	California
Desert Regional Medical Center /ID# 272437	Palm Springs	California
Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823	Golden	Colorado
City Of Hope - Atlanta. /ID# 273092	Newnan	Georgia
Rush University Medical Center /ID# 242103	Chicago	Illinois
City Of Hope - Chicago /ID# 274430	Zion	Illinois
Northwest Cancer Center - Dyer Clinic /ID# 269787	Dyer	Indiana
Cancer Center of Kansas - Wichita /ID# 270117	Wichita	Kansas
University of Kentucky Chandler Medical Center. /ID# 242087	Lexington	Kentucky
University of Maryland, Baltimore /ID# 242216	Baltimore	Maryland
Henry Ford Hospital /ID# 266446	Detroit	Michigan
Gulfport Memorial Hospital /ID# 268104	Gulfport	Mississippi
New York Medical College /ID# 265799	Valhalla	New York
East Carolina University - Brody School of Medicine /ID# 242227	Greenville	North Carolina
Thompson Cancer Survival Ctr /ID# 242149	Knoxville	Tennessee
Community Cancer Trials Of Utah /ID# 271715	Ogden	Utah
Utah Cancer Specialists - Salt Lake City /ID# 268603	Salt Lake City	Utah
Veterans Affairs Medical Center - Salt Lake City /ID# 265329	Salt Lake City	Utah
Hospital Universitario Austral /ID# 242791	Pilar	Buenos Aires
Fundaleu /Id# 242789	Ciudad Autonoma de Buenos Aire	Buenos Aires F.D.
Instituto Alexander Fleming /ID# 263804	Ciudad Autonoma de Buenos Aire	Buenos Aires F.D.
Canberra Hospital /ID# 265312	Garran	Australian Capital Territory
Royal Prince Alfred Hospital /ID# 263242	Sydney	New South Wales
Wollongong Hospital /ID# 244646	Wollongong	New South Wales
Toowoomba Hospital /ID# 263243	Toowoomba	Queensland
Monash Health - Monash Medical Centre /ID# 262783	Clayton	Victoria
Royal Perth Hospital /ID# 243790	Perth	Western Australia
Universitair Ziekenhuis Brussel /ID# 242574	Jette	Brussels Capital
Centre Hospitalier Epicura - Hornu /ID# 265148	Boussu	Hainaut
Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 242565	Yvoir	Namur
Universitair Ziekenhuis Leuven /ID# 246671	Leuven	Vlaams-Brabant
AZ-Delta. /ID# 264740	Roeselare	West-Vlaanderen
Hospital Sao Rafael /ID# 262949	Salvador	Estado de Bahia
Hospital Erasto Gaertner /ID# 264049	Curitiba	Puerto Rico
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 264045	Ribeirão Preto	São Paulo
Hospital Alemao Oswaldo Cruz /ID# 247418	São Paulo	Brazil
Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 263944	São Paulo	Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 242425	São Paulo	Brazil
UMHAT Sveti Georgi /ID# 242905	Plovdiv	Bulgaria

+ 136 more sites — see the full list on the official registry below.

On this site

📄 Rituxan (rituximab) drug profile → 📄 Revlimid (lenalidomide) drug profile →

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