A Study Evaluating the Safety, Pharmacokinetics (what the body does to a drug), and Efficacy of Mosunetuzumab given subcutaneously (SC) or intravenously (IV) plus Lenalidomide (+Len) in Patients with Follicular Lymphoma
- Conditions
- Follicular Lymphoma (FL)MedDRA version: 24.0Level: PTClassification code: 10085128Term: Follicular lymphoma Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-507236-20-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 187
Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2, R/R FL after treatment with at least one prior systemic lymphoma therapy which includes prior immunotherapy or chemoimmunotherapy, Previously untreated patients with FL must require systemic therapy assessed by investigator based on GELF criteria, Histologically documented FL of Grade 1, 2, or 3a, and that expresses CD20 as determined by the local laboratory, Fluorodeoxyglucose avid lymphoma (i.e., positron emission tomography (PET) positive lymphoma), At least one bi dimensionally measurable nodal lesion (>1.5 cm in its largest dimension by PET- computed tomography (CT) scan), or at least one bi dimensionally measurable extranodal lesion (>1.0 cm in its largest dimension by PET-CT scan)
Any history of Grade 3b FL, Any History of disease transformation and/or diffuse large B-cell lymphoma, Active or history of central nervous system lymphoma or leptomeningeal infiltration, Documented refractoriness to lenalidomide, defined as no response (PR or CR) within 6 months of therapy, Prior standard or investigational anti-cancer therapy as specified, Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade <=2 prior to Day 1 of Cycle 1
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