Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma (EPCORE DLBCL-3)
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ClinicalTrials.gov Identifier: NCT05660967 |
Recruitment Status :
Recruiting
First Posted : December 21, 2022
Last Update Posted : April 3, 2024
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Sponsor:
Genmab
Collaborator:
AbbVie
Information provided by (Responsible Party):
Genmab
Tracking Information | |||||
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First Submitted Date ICMJE | November 29, 2022 | ||||
First Posted Date ICMJE | December 21, 2022 | ||||
Last Update Posted Date | April 3, 2024 | ||||
Actual Study Start Date ICMJE | March 6, 2023 | ||||
Estimated Primary Completion Date | March 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Complete Response (CR) rate [ Time Frame: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years ] Percentage of participants achieving CR. Assessed by the Investigator per Lugano criteria
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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. | ||||
Detailed Description | This is an open-label, multicenter, global phase-2 trial evaluating the efficacy and safety of epcoritamab monotherapy and epcoritamab plus lenalidomide in elderly patients who are deemed anthracycline ineligible. The trial is designed in two stages:
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Diffuse Large B Cell Lymphoma | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
180 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | April 2026 | ||||
Estimated Primary Completion Date | March 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined inclusion/exclusion criteria may apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 75 Years and older (Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Austria, Belgium, Czechia, France, Germany, Italy, Japan, Korea, Republic of, Poland, Spain, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05660967 | ||||
Other Study ID Numbers ICMJE | GCT3013-06 2021-005744-29 ( EudraCT Number ) jRCT2021230015 ( Registry Identifier: Japan Registry for Clinical Trials (jRCT) ) 1006219 ( Other Identifier: IRAS ID; UK Research Summaries Database ) 2023-504832-16-00 ( Registry Identifier: EU CTIS ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Genmab | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Genmab | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | AbbVie | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Genmab | ||||
Verification Date | April 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |