Diffuse Large B-Cell Lymphoma (DLBCL) MedDRA version: 21.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age = 18 years old and 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 per institutional standard practice should be considered for subjects with ANC =65 years) yes F.1.3.1 Number of subjects for this age range 405
Exclusion criteria
Exclusion criteria: 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 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 .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: The first secondary objective is to evaluate and compare PFS between the two treatment arms in subjects with newly diagnosed DLBCL with an IPI of 2-5 (i.e., all randomized subjects). The other secondary objectives are to evaluate and compare each key secondary endpoint for both the subset of subjects with an IPI of 3-5 and all randomized subjects per the hierarchical order specified in protocol Section 7.7.;Primary end point(s): The primary endpoint is PFS defined as the duration from the date of randomization to the date of any of the following (whichever occurs first). The primary analysis population is the subset of subjects with an IPI of 3-5. - Disease progression based on the independent review committee (IRC) assessment per Lugano criteria. - Death due to any causes. ;Timepoint(s) of evaluation of this end point: Throughout the study. Survival follow-up will continue until death, withdrawal of the subject, lost to follow up, study discontinuation, study termination by the Sponsor or the study meets the specified OS event goal (estimated to be approximately 6.5 years after first subject first dose), whichever comes first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary efficacy endpoints include the following: - PFS in all randomized subjects. - The subsequent key secondary endpoints specified below will be analyzed for both the subset of subjects with an IPI of 3-5 and all randomized subjects per the hierarchical order specified in protocol Section 7.7: - Event-free survival, defined as the duration from randomization to the date of any of the following (whichever occurs first): - Disease progression based on the IRC assessment per Lugano criteria. - IRC-assessed response of partial response or stable disease followed by non-protocol-specified new antilymphoma therapy (NALT), unless the primary reasons for discontinuing every component of study treatment are not efficacy related. - A positive biopsy on or after end-of-treatment (EOT) (i.e., completion of 8 cycles of treatment), regardless of whether NALT is initiated. - Death due to any causes. - CR on or after treatment completion (i.e., at the EOT scan [Week 28 or 6 (+2) weeks from Cycle 8 Day 1, whichever is later]) by fluorodeoxyglucose positron emission tomography, based on IRC assessment per Lugano criteria. - Overall survival, defined as time from randomization until death due to any causes. - Minimal residual disease negativity. Additional efficacy endpoints are included in the protocol body.;Timepoint(s) of evaluation of this end point: - Event-free Survival/ Overall Survival: Throughout the study until death, withdrawal of the subject, lost to follow up, study discontinuation, study termination by the Sponsor or the study meets the specified OS event goal (estimated to be approximately 6.5 years after first subject first dose), whichever comes first - CR: Throughout the study. - MRD: Throughout study and Post-Treatment Follow-up visits until subject discontinuation. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed