ACTIVE_NOT_RECRUITING

Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma

Conditions

Diffuse Large B-Cell Lymphoma Double-hit lymphoma Triple-hit lymphoma Follicular grade 3B T-cell/histiocyte rich LBCL DuoBody®Anti-CD3 Anti-CD20 Subcutaneous Bispecific antibody EPCORE

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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

The purpose of the study is to examine efficacy and safety of epcoritamab with and without lenalidomide in newly diagnosed elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) who cannot tolerate anthracycline therapy. Epcoritamab (also known as EPKINLY™, GEN3013 and DuoBody®-CD3xCD20) is an antibody that has already been tested in several clinical studies. All patients will receive active treatment. There is an equal chance of receiving epcoritamab or epcoritamab plus lenalidomide.

Official Title

Efficacy and Safety of Epcoritamab Monotherapy and in Combination With Lenalidomide as First-line Therapy for Anthracycline-ineligible Diffuse Large B-Cell Lymphoma Patients, an Open-label, Randomized, Multicenter, Global Phase 2 Trial

Quick Facts

Study Start:2023-03-06

Study Completion:2027-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05660967

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:75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Must have newly diagnosed CD20+ large cell lymphoma. * Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to: * Being age ≥80 years; AND/OR * Being 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.	* 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: * Major surgery within 4 weeks prior to the first dose of epcoritamab; * Non-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; * Autologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic stem cell transplantation, or solid organ transplantation; * Live, attenuated vaccines within 30 days prior to initiation of epcoritamab; * Investigational 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); * Invasive 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.

Inclusion Criteria

Exclusion Criteria

* Must have newly diagnosed CD20+ large cell lymphoma.
* Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to:
* Being age ≥80 years; AND/OR
* Being 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.

* 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:
* Major surgery within 4 weeks prior to the first dose of epcoritamab;
* Non-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;
* Autologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic stem cell transplantation, or solid organ transplantation;
* Live, attenuated vaccines within 30 days prior to initiation of epcoritamab;
* Investigational 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);
* Invasive 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.

Contacts and Locations

Study Locations (Sites)

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188

United States

Collaborators and Investigators

Sponsor: Genmab

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 Date2023-03-06

Study Completion Date2027-07-31

Study Record Updates

Study Start Date2023-03-06

Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

Double-hit lymphoma
Triple-hit lymphoma
Follicular grade 3B
T-cell/histiocyte rich LBCL
DuoBody®
Anti-CD3
Anti-CD20
Subcutaneous
Bispecific antibody
EPCORE

Additional Relevant MeSH Terms

Diffuse Large B-Cell Lymphoma