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 lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-000168-31-IT
- Lead Sponsor
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 900
1.Adult male or female, = 18 years old and < 80 years old, with a life expectancy of = 12 months.
2.Subject is planned to receive treatment with 6 cycles of standard R CHOP per investigator determination.
3.Subject must have newly diagnosed, histologically confirmed CD20+ DLBCL (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:
- DLBCL, Not Otherwise Specified (NOS).
- High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
- T-cell/histiocyte-rich large B-cell lymphoma.
- Epstein Barr virus-positive DLBCL, NOS.
- Follicular lymphoma Grade 3b.
4.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.
5.Subject must have an IPI score of 2-5. The number of subjects with IPI 2 will be capped at 35% of the overall sample size.
6.Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that subject with an initial ECOG performance status = 3 may be screened if pre-phase treatment is planned. Subject may be eligible if ECOG performance status were to improve to 0-2 during pre phase treatment.
7.Subject has at least one target lesion defined as:
- = 1 measurable nodal lesion (long axis > 1.5 cm ) or = 1 measurable extra-nodal lesion (long axis > 1 cm) on CT scan or MRI.
AND
- PET-positive on PET-CT scan.
8.Laboratory values meeting the following criteria within the screening period prior to the first dose of study drug:
- Absolute neutrophil count (ANC) = 0.5 × 109/L. (antibacterial prophylaxis [fluoroquinolone preferred unless contraindicated] would be required for ANC < 1.0 x 109/L)
- Hemoglobin = 8 g/dL.
- Platelet count = 75 × 109/L, or = 25 × 109/L in the presence of bone marrow involvement or splenomegaly
- Serum aspartate aminotransferase or serum alanine aminotransferase = 3.0 × upper limit of normal (ULN) unless due to hepatic involvement of disease or non-hepatic origin.
- Total bilirubin level = 1.5 × ULN, or = 5 × ULN for subjects with hepatic involvement of disease or non-hepatic origin. Subjects with Gilbert's syndrome may have total bilirubin levels > 1.5 × ULN, but direct bilirubin must be < 2 × ULN.
- Estimated creatinine clearance = 40 mL/min, as calculated by the Cockcroft-Gault formula with considerations for body weight.
- Prothrombin time/international normalized ratio/activated partial thromboplastin time = 1.5 × ULN, unless receiving anticoagulation.
9. Left ventricular ejection fraction must be = 50% by multi gated acquisition or transthoracic echocardiography at Screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 495
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 405
1. 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.
2. 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 (ECG) showing a baseline QT interval as corrected by Fridericia’s formula (QTcF) > 470 msec (male) or > 480 sec (female)
OR
• Other clinically significant electrocardiogram 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