A study evaluating the safety and efficacy of GLPG5101 (19CP02) in subjects with non-Hodgkin lymphoma
- Conditions
- Relapsed/refractory B-cell non-Hodgkin lymphomaMedDRA version: 20.0Level: HLGTClassification code: 10025320Term: Lymphomas non-Hodgkin's B-cell Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-502661-23-00
- Lead Sponsor
- Galapagos
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
1. Signed informed consent form, 2. Age = 18 years, 3.1 Histologically confirmed diagnosis of one of the following non-Hodgkin lymphoma subtypes: Aggressive DLBCL, FL grade 1, 2 or 3A, MZL, or MCL, BL, PCNSL, 4.1 Relapsed or refractory disease, 5.1 Measurable disease according to the Lugano classification or IPCG criteria for PCNSL, 6. ECOG performance status of 0-2 (Subjects with ECOG 2 must have serum albumin = 3.4 g/dL), 7 & 8. Adequate bone marrow, renal, hepatic and pulmonary function
Richter's transformation, Selected prior treatments as defined in the protocol, History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 3 years (exceptions per protocol), Active CNS involvement (with neurological changes) by disease under study, Infection with HIV, hepatitis B or hepatitis C virus
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