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)
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)MedDRA version: 21.0Level: PTClassification code: 10012818Term: Diffuse large B-cell lymphoma Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505277-32-00
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1014
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., Availability of archival or freshly collected tumor tissue at Screening. Archival paraffin-embedded tissue must be obtained within 8 weeks prior to Cycle 1 Day 1., 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.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method