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A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Capsules Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
EU CTIS ID: 2024-510965-41-00
What this study is testing
The primary objective of this study is to evaluate whether epcoritamab plus lenalidomide (E-Len) can improve outcomes as measured by progression-free survival (PFS) versus rituximab plus gemcitabine and oxaliplatin (R-GemOx) in relapsed or refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject must have histologically confirmed CD20+ DLBCL and documented in the most recent representative pathology report, inclusive of the following according to the 5th edition of the WHO (2022) Classification of Haematolymphoid Tumours: Lymphoid Neoplasms: • DLBCL, NOS including de novo or histologically transformed from an earlier diagnosis of FL or MZL • DLBCL/HGBCL with MYC and BCL2 rearrangements • Follicular large B-cell lymphoma (FLBL; previously FL Grade 3B) • T-cell/histiocyte-rich large B-cell lymphoma • Epstein Barr Virus-positive DLBCL
- Subject must have 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. Note: Relapsed disease is defined as disease that has recurred ≥ 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response to prior therapy, or progressed within 6 months after completion of therapy (including maintenance therapy).
- Subject must meet at least 1 of the following criteria: • Failed prior ASCT, defined as relapsed after ASCT or been refractory to 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 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 PR or CR while on prior CAR-T therapy
- Subject must have measurable disease defined as: • ≥ 1 measurable nodal lesion (long axis > 1.5 cm) or ≥ 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT or MRI AND •F-FDG PET scan positive
- Subject must have an Eastern Cooperative Oncology Group Performance status score of 0 to 2.
You likely can't join if
- Prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with R-GemOx or GemOx.
- Lenalidomide exposure within 12 months prior to screening or history of documented refractoriness to lenalidomide with refractoriness defined as: • best response SD or PD, or • PD within 6 months of completion of the therapy
- Best response to prior CAR-T therapy of SD or PD. Subject should not have received any treatment with CAR-T therapy within 90 days prior to randomization; any CAR-T related toxicity should have been resolved for at least 30 days.
- Current evidence of primary CNS lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening
- Current autoimmune disease requiring immunosuppressive therapy except for up to 20 mg daily prednisone or equivalent.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- South Africa
- Taiwan
- Singapore
- Turkey
- United States
- United Kingdom
- Canada
- Mexico
- Japan
- Brazil
- Argentina
- Australia
- China
- Chile
- Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; South Africa; Taiwan; Singapore; Turkey; United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.