Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
This study is evaluating whether an experimental treatment called GLPG5101 helps to treat non-Hodgkin lymphoma (NHL) and if it is safe to use.
This study will be carried out in 2 phases:
Full description
Phase 1 Dose escalation phase:
The dose escalation phase is designed to select the doses for dose expansion based on efficacy and safety outcomes.
Three dose levels of GLPG5101 will be evaluated to determine the recommended phase 2 doses (RP2Ds).
Participants with aggressive or indolent forms of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (r/r NHL) including follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and Diffuse large B-cell lymphoma (DLBCL) will be enrolled. In case any safety or efficacy differences based on histological subtype of the disease are observed, it may be decided to make decisions regarding dose escalation for a specific subtype(s) independently, upon recommendation by the Safety Review Committee (SRC). Hence the RP2Ds may be different for different subtypes.
Phase 2 Dose expansion phase:
After determination of the RP2Ds, the study continues with the dose expansion phase. Different doses deemed safe by the SRC within the same indication may be explored in the dose-expansion phase to help select the optimal dose for further development.
During this phase, participants will be enrolled into separate disease cohorts as defined by their NHL subtype:
Participants per disease cohort will be treated at the selected RP2Ds for that disease subtype.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
250 participants in 12 patient groups
Loading...
Central trial contact
Galapagos Medical Information
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal