Authorised Therapeutic confirmatory (Phase III) Diffuse Large B-Cell Lymphoma (DLBCL)

This study is to find out the safety and effectiveness of Epcoritamab together with R-CHOP (rituximab, cyclophosphamide, doxorubicin HCL, vincristine, and prednisone) compared to only R-CHOP in subjects with newly diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

EU CTIS ID: 2023-505277-32-00

What this study is testing

The primary objective of this study is to evaluate whether the addition of epcoritamab to 6 cycles of standard R-CHOP followed by 2 cycles of epcoritamab can prolong progression-free survival (PFS) compared with 6 cycles of standard R-CHOP alone followed by 2 cycles of rituximab in subjects with newly diagnosed DLBCL with an IPI of 3-5.

  • 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

  • Age ≥ 18 years old and < 80 years old, with a life expectancy of ≥ 12 months.
  • Subject is planned to receive treatment with 6 cycles of standard R CHOP per investigator determination.
  • Subject must have an IPI score of 2-5. The number of subjects with an IPI 2 of will not exceed approximately 30% of the overall sample size.

You likely can't join if

  • Subject with history of prior systemic anti-lymphoma therapy for DLBCL (including any definitive radiotherapy with curative intent) other than corticosteroids with or without vincristine during pre-phase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
  • Subject has clinically significant cardiovascular disease, including: • Myocardial infarction or stroke within 6 months prior to enrollment. OR • The following conditions within 3 months prior to enrollment: unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III IV), uncontrolled cardiac arrhythmia OR • Screening 12-lead electrocardiogram showing a baseline QT interval as corrected by Fridericia's formula > 470 msec (male) or > 480 msec (female) OR • Other clinically significant ECG abnormalities within 6 months prior to enrollment unless deemed stable and appropriately treated.

The study team makes the final eligibility decision.

Where it's taking place

  • Japan
  • New Zealand
  • China
  • United States
  • Mexico
  • Puerto Rico
  • Turkey
  • South Africa
  • Israel
  • Canada
  • Australia
  • Taiwan
  • Argentina
  • United Kingdom
  • Korea, Republic of
  • Switzerland
  • Brazil

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, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Japan; New Zealand; China; United States; Mexico; Puerto Rico and 11 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.