This study is to find out about the Safety and Efficacy of Epcoritamab in Combination with Rituximab and Lenalidomide (R2) compared to R2 in Subjects with Relapsed or Refractory Follicular Lymphoma
- Conditions
- Relapsed/Refractory Follicular LymphomaMedDRA version: 24.0Level: PTClassification code 10085128Term: Follicular lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-000169-34-SK
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
1. Adult individuals, at least 18 years old.
2. Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2.
3. Subject has:
•Fluorodeoxyglucose-positron emission tomography (FDG PET) scan
demonstrating positive lesion compatible with computed tomography
(CT) or magnetic resonance image (MRI)-defined anatomical tumor sites
AND
•=1 measurable nodal lesion (long axis > 1.5 cm) or =1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or magnetic resonance image (MRI)
4. Subject must have histologically confirmed classic FL (previously Grade 1 to 3a FL) stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours7.
5. Subject must have R/R disease after receiving treatment with at least
one prior antilymphoma regimen that contained an antiCD20 monoclonal
antibody in combination with chemotherapy. (Subject who received only
prior anti-CD20 monoclonal antibody monotherapy and/or radiation
therapy is not eligible.)
6. Subject must be eligible to receive R2 per investigator determination
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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250
1. Subject must not have documented refractoriness to lenalidomide, with refractoriness defined as:
o Best response to lenalidomide of stable disease or progressive disease, or
o Progressive disease within 6 months of completion of lenalidomide therapy
2. Subjects must not have had lenalidomide exposure within 12 months prior to randomization
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