B-cell Lymphoma MedDRA version: 20.0 Level: HLT Classification code 10012819 Term: Diffuse large B-cell lymphomas System Organ Class: 100000004851
Conditions
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Must have newly diagnosed CD20+ large cell lymphoma limited to the following histologies (according to the World Health Organization [WHO] 2016 classification). •Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to: oBeing age =80 years; AND/OR oBeing age =75 years and having important comorbid condition(s), which are likely to have a negative impact on tolerability of anthracycline-based therapy/cytotoxic chemotherapy, Have Immune Effector Cell-Associated Encephalopathy (ICE) score of at least 8 out of 10. •Have Ann Arbor Stage II-IV disease. •Have ECOG PS of 0, 1, or 2; (ECOG PS of 3 may be considered if impairment is attributed to current lymphoma/DLBCL and if pre-phase treatment during the screening phase results in an improvement of ECOG PS to =2 prior to enrollment.) •Have measurable disease as per Lugano criteria. •Have acceptable organ function based on baseline bloodwork. •Must have fresh (preferred) or archival biopsy material at screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: •Has known active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection at trial enrollment, including COVID-19 infection. •Has severe cardiovascular disease (other than those eligibility criteria that preclude the subject from receiving anthracycline-based therapy/cytotoxic chemotherapy), •Has been exposed to/received any of the following prior therapies, treatments, or procedures within the specified timeframes: oMajor surgery within 4 weeks prior to the first dose of epcoritamab; oNon-investigational antineoplastic agents (except anti-CD20 monoclonal antibodies) or any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab; oAutologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic stem cell transplantation, or solid organ transplantation; oLive, attenuated vaccines within 30 days prior to initiation of epcoritamab; oInvestigational vaccines within 28 days before the planned first dose of epcoritamab (ie, experimental and/or non-authorized SARS-CoV-2 vaccinations and therapies are not allowed); oInvasive investigational medical device use within 28 days before the planned first dose of epcoritamab. •Has primary central nervous system (CNS) tumor or known CNS involvement or intracranial involvement as confirmed by mandatory brain magnetic resonance imaging/computed tomography (MRI/CT) scan at screening and, if clinically indicated, by lumbar puncture. •Has a seizure disorder requiring anti-epileptic therapy or experienced a seizure within 6 months of signing an informed consent form. •Has known past or current malignancy other than inclusion diagnosis, with exceptions as stated in protocol. •Has known or suspected allergies, hypersensitivity, or intolerance to either of the trial treatments or has known or suspected contraindication to the use of all locally available anti-cytokine therapies per local guidelines for management of cytokine release syndrome (CRS). •Has active hepatitis B virus (HBV) (DNA polymerase chain reaction [PCR]-positive) or hepatitis C virus (HCV) (RNA PCR-positive) infection, current alcohol abuse, or cirrhosis. •Has active cytomegalovirus (CMV) infection (DNA PCR-positive) requiring treatment. •Has suspected active or inadequately treated latent tuberculosis. •Has a known history of seropositivity for HIV. Note: HIV testing is required at screening only if required per local health authorities or institutional standards.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the clinical efficacy of epcoritamab monotherapy or epcoritamab and lenalidomide ;Secondary Objective: 1. Evaluate other efficacy measures of epcoritamab monotherapy or epcoritamab and lenalidomide 2. Evaluate safety and tolerability of epcoritamab monotherapy or epcoritamab and lenalidomide 3. Evaluate immunogenicity 4. Assess the pharmacokinetics of epcoritamab 5. Evaluate patient-reported outcomes related to lymphoma symptoms;Primary end point(s): Complete response (CR) rate determined by Lugano criteria;Timepoint(s) of evaluation of this end point: Please refer to the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Duration of response (DOR) determined by Lugano criteria 2. Duration of complete response (DOCR) determined by Lugano criteria 3. Time to response (TTR) determined by Lugano criteria 4. Overall response rate (ORR) determined by Lugano criteria 5. Progression-free survival (PFS) determined by Lugano criteria 6. Time to next (anti-lymphoma) therapy (TTNT) 7. Rate and duration of minimal residual disease (MRD) negative status 8. Overall survival (OS) 9. Incidence of dose-limiting toxicities (DLTs) 10. Incidence and severity of adverse events (AEs) 11. Incidence and severity of changes in laboratory values 12. Incidence of antidrug antibodies (ADAs) to epcoritamab 13. PK parameters (clearance, volume of distribution, area under-the-concentration-time curve [AUC0-last and AUC0-8], maximum concentration [Cmax], time of Cmax [Tmax], predose values, and half-life [t½]) 14. Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym);Timepoint(s) of evaluation of this end point: Please refer to the Protocol. | — |
Countries
Austria, Belgium, Czechia, Czech Republic, Denmark, France, Germany, Italy, Japan, Korea, Republic of, Poland, Portugal, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Genmab A/S
Outcome results
None listed