EPCORITAMAB for Follicular lymphoma

Inclusion criteria

• {"criterion_text":"- Diagnosis of follicular lymphoma (FL)."}
• {"criterion_text":"- Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours."}
• {"criterion_text":"- Are willing and able to comply with procedures required in this protocol."}
• {"criterion_text":"- Must have stage II, III or IV disease."}
• {"criterion_text":"- Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria."}
• {"criterion_text":"- Has one or more target lesions: (a) A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and (b) >=1 measurable nodal lesion (long axis >1.5cm) or >=1 measurable extra-nodal lesion (long axis >1.0 cm) on CT scan or MRI"}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status 0–2."}
• {"criterion_text":"- Able to receive at least one of the standard of care CIT treatment regimens (Arm B) at the discretion of the Investigator, and R2 (Arm C)"}

Exclusion criteria

• {"criterion_text":"- Had major surgery within 4 weeks prior to randomization."}
• {"criterion_text":"- Have active cytomegalovirus (CMV) disease."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the Complete Response rate at 30 months/120 weeks (CR30) in Arm A1 (ER2) versus Arm B (CIT), as determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.","definition_or_measurement_approach":"Determined by PET-CT per Lugano 2014 criteria, as assessed by Independent Review Committee (IRC)."}

Secondary endpoints

• {"endpoint_text":"- OS","definition_or_measurement_approach":"Overall survival (OS) — time to death from any cause (no further measurement detail provided in endpoint list)."}
• {"endpoint_text":"- MRD negativity rate","definition_or_measurement_approach":"Rate of minimal residual disease (MRD) negativity (secondary objective text specifies assessment at C3D1 / mid-induction)."}
• {"endpoint_text":"- PROs: Change from baseline in physical functioning (assessed by the physical functioning scale of the EORTC QLQ-C30) at Week 21 for Arm A1 and Week 21 (G/R-Benda regimen)/22 (G/R-CHOP regimen) for Arm B.","definition_or_measurement_approach":"Change from baseline in physical functioning as measured by the Physical Functioning scale of the EORTC QLQ-C30 at the specified week(s)."}

Methods

• Doctor-to-patient email/letter (materials exist per country: e.g. K2_M22-003_DE_Recruitment material Doctor to Patient Email_German_Public for Germany; K2 materials for BE, NL, PT, ES, SE, IT, etc.) — channel: email/letter via treating physicians; target: potential patient participants.
• Study/Program website copy and program-level website (materials listed per country, e.g. 'Website copy', 'Program-level Website copy', 'Epcore Website Copy') — channel: web; target: potential participants and public.
• Patient downloadable study guide (country-specific PDFs) — channel: downloadable PDF; target: prospective participants/caregivers.
• Recruitment brochures (country-specific K2 recruitment brochures) — channel: printed/PDF brochures distributed by sites or online; target: potential participants.
• Website prescreener / Web-based pre-screening tools (country-specific 'Website Prescreener', 'Web-based Pre-screening') — channel: online prescreener; target: self-identifying potential participants.
• Patient-Doctor discussion guides and site-facing materials (country-specific) — channel: clinical site discussions; target: facilitate physician/patient conversation at sites.
• Digital ads and search ads (explicitly listed for Spain: 'Digital ads', 'Search ads') — channel: online advertising; target: general public/potential participants in specified countries.
• Doctor-to-Patient Email variants in multiple languages (e.g., BE English/Dutch/French/German versions) — channel: email; target: patients via treating clinicians.

Primary sponsor

Full Name

AbbVie Deutschland GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

Cytel Inc.

Responsibilities

Service provider to assist with iDMC activities

Name

Endpoint Clinical Inc.

Third parties

• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reinbursement","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Service provider to assist with iDMC activities","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"ePRO","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Labcorp","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Thermometer Supplier","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical Imaging, IRC","organisation_type":"Pharmaceutical company"}