Diffuse Large B-Cell Lymphoma
Conditions
Keywords
Epcoritamab, Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin, Diffuse Large B-Cell Lymphoma, DLBCL, Epkinly, ABBV-GMAB-3013
Brief 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.
Interventions
DRUGEpcoritamab
Subcutaneous Injection
DRUGRituximab
Intravenous (IV) Infusion
DRUGLenalidomide
Oral Capsule
DRUGOxaliplatin
IV Infusion
DRUGGemcitabine
IV Infusion
Sponsors
Genmab
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arm A vs Arm B: Percentage of Participants Who Achieve Complete response (CR) | Up to 4 Years | CR is defined as the percentage of participants who achieve CR determined by Lugano 2014 criteria, as assessed by an IRC that is blinded to treatment arm prior to the initiation of new anti-lymphoma therapy. |
| Arm A vs Arm B: Overall Survival (OS) | Up to 4 Years | OS is defined as the time from randomization to death from any cause. |
| Arm A vs Arm B: Percentage of Participants Who Achieve Minimal Residual Disease (MRD) Negativity Rate | Up to 4 Years | The MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of new anti-lymphoma therapy. |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, France, Greece, Hungary, Japan, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Serbia, Singapore, South Africa, South Korea, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed