- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05733650
Expanded Access Program for Epcoritamab
Expanded Access Program (EAP) to Provide Epcoritamab (GEN3013) to Eligible Patients With Relapsed or Refractory Large B-cell Lymphoma
The purpose of this program is to provide investigational epcoritamab, an antibody also known as GEN3013 (DuoBody-CD3xCD20), in an expanded access setting for eligible patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) who have a high unmet medical need with no other treatment options. It is a requirement that patients do not qualify for an ongoing epcoritamab clinical program or are unable to participate due to logistical reasons.
Access to investigational epcoritamab can be requested by contacting preapprovalaccessprograms@genmab.com.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Expanded Access Type
- Treatment IND/Protocol
Contacts and Locations
Study Contact
- Name: Genmab Managed Access Information
- Phone Number: +1 609-430-2481
- Email: PreApprovalAccessPrograms@genmab.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be 18 years of age or older
- R/R CD20+ mature B-cell neoplasm
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2
- ≥ 2 prior lines of antineoplastic therapy, including ≥ 1 anti-CD20 monoclonal antibody (mAb)
- Fluorodeoxyglucose (FDG) positron emission tomography (PET)-avid and measurable disease by computed tomography/magnetic resonance imaging (CT/MRI)
- Patients considering the EAP should have no other available therapeutic option and cannot be eligible for other epcoritamab trials.
- Patients considering the EAP must be located in proximity to a US site given that the EAP is currently available only in the United States.
- Prior to initiating any program-related assessments or procedures, patients (or their legally acceptable representative) must sign an informed consent form (ICF), which indicates the purpose of the program, the procedures required for the program, and confirms the patient's willingness to participate in the program.
Exclusion Criteria:
- Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20
- Prior treatment with CAR-T therapy within 100 days prior to first epcoritamab administration
- Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma
- Confirmed history of or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy. Low-dose prednisolone for rheumatoid arthritis or similar conditions is allowed.
- Active hepatitis B or hepatitis C
- Known clinically significant cardiac disease
- Pregnancy or breastfeeding
- Known hypersensitivity to allopurinol or rasburicase
Study Plan
How is the study designed?
Collaborators and Investigators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCT3013-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Mediastinal Large B-cell Lymphoma (PMBCL)
-
Jennifer Crombie, MDMerck Sharp & Dohme LLCRecruitingPrimary Mediastinal Large B-cell Lymphoma (PMBCL) | Primary Mediastinal Large B Cell Lymphoma | T-Cell/Histiocyte-Rich Large B-Cell Lymphoma | Primary Mediastinal Large B-Cell Lymphoma Refractory | Primary Mediastinal Large B-Cell Lymphoma Recurrent | Epstein-Barr Virus Positive Diffuse Large...United States
-
Fondazione Italiana Linfomi - ETSNot yet recruitingClassical Hodgkin Lymphoma | Primary Mediastinal Large B-cell Lymphoma (PMBCL) | Diffuse Large B Cell Lymphoma (DLBCL)Italy
-
IRCCS San RaffaeleActive, not recruitingPrimary Mediastinal Large B-cell Lymphoma (PMBCL)
-
Taizhou HoudeAoke Biomedical Co., Ltd.Not yet recruitingPrimary Mediastinal Large B-Cell Lymphoma (PMBCL)China
-
Fondazione Italiana Linfomi - ETSActive, not recruitingPrimary Mediastinal Large B-cell Lymphoma (PMBCL)Italy
-
Curocell Inc.RecruitingHigh-grade B-cell Lymphoma | Diffuse Large B-cell Lymphoma (DLBCL) | Primary Mediastinal Large B-Cell Lymphoma (PMBCL) | Transformed Follicular Lymphoma (TFL) | Refractory Large B-cell Lymphoma | Relapsed Large B-cell LymphomaKorea, Republic of
-
M.D. Anderson Cancer CenterRecruitingAnn Arbor Stage I Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Ann Arbor Stage II Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Ann Arbor Stage III Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Ann Arbor Stage IV Primary Mediastinal (Thymic) Large B-Cell LymphomaUnited States
-
IRCCS San RaffaeleRecruitingPrimary Mediastinal Large B-cell Lymphoma (PMBCL)Italy
-
H. Lee Moffitt Cancer Center and Research InstituteRecruitingFollicular Lymphoma | Primary Mediastinal Large B-Cell Lymphoma (PMBCL) | Diffuse Large-Cell Lymphoma | Transformed Follicular Lymphoma (TFL) | High-grade B-cell Lymphoma (HGBCL)United States
-
Azienda Socio Sanitaria Territoriale degli Spedali...RecruitingAcute Lymphoblastic Leukemia (ALL) | Primary Mediastinal Large B-cell Lymphoma (PMBCL) | Diffuse Large B Cell Lymphoma (DLBCL)Italy
Clinical Trials on Epcoritamab
-
AbbVieGenmabRecruitingDiffuse Large B-Cell Lymphoma | Classic Follicular LymphomaUnited States, Puerto Rico
-
AbbVieGenmabRecruitingNon-hodgkin LymphomaUnited States, Australia, France, Israel, Korea, Republic of, Spain, Taiwan, Japan, Italy, Belgium, Germany, Canada, Turkey, Czechia
-
GenmabAbbVieActive, not recruitingSmall Lymphocytic Lymphoma (SLL) | DLBCL | Primary Mediastinal Large B-cell Lymphoma (PMBCL) | MCL | Marginal Zone Lymphoma (MZL) | High-grade B-cell Lymphoma (HGBCL) | FLKorea, Republic of, United States, Australia, Singapore, Netherlands, Sweden, France, Finland, United Kingdom, Spain, Germany, Denmark, Italy, Poland, Canada
-
Stichting Hemato-Oncologie voor Volwassenen NederlandGerman CLL Study Group; Nordic CLL Study GroupRecruitingCLL/SLLNetherlands, Denmark, Belgium, Germany
-
GenmabAbbVieActive, not recruitingDiffuse Large B-cell LymphomaKorea, Republic of, Spain, Taiwan, Belgium, France, Israel, United Kingdom, China, United States, Netherlands, Japan, Sweden, Turkey, Australia, Singapore, Germany, Denmark, Poland, Italy, Hungary, Austria, Russian Federation, Norway, Canad... and more
-
GenmabAbbVieTerminatedFollicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Chronic Lymphocytic Leukemia | Diffuse Large B-cell Lymphoma | Small Lymphocytic Lymphoma | High-grade B-cell Lymphoma | Primary Mediastinal Large B-cell LymphomaUnited States, Spain, Netherlands, Belgium, France, Denmark
-
Australasian Leukaemia and Lymphoma GroupNot yet recruitingHigh-grade B-cell Lymphoma | DLBCL - Diffuse Large B Cell Lymphoma | High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements | DLBCL, Nos Genetic Subtypes | High Grade B-Cell Lymphoma, Not Otherwise Specified | Follicular Large Cell Lymphoma, Relapsed | Follicular Large Cell Lymphoma
-
Reid Merryman, MDAbbVie; GenmabRecruitingFollicular Lymphoma | Low Grade Non-Hodgkin's Lymphoma, AdultUnited States
-
Dipenkumar ModiGenmabRecruitingRelapsed Cancer | Refractory Cancer | Large Cell Lymphoma, DiffuseUnited States