Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL
ConditionNon-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Cologne
About this trial
Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in patients ineligible for HCT-ASCT with Primary Central Nervous System Lymphoma (PCNSL)
Eligibility criteria
Qualifiers
Age 18-69 years with ECOG PS ≥2 or age ≥70 years, and ineligible for HCT-ASCT as per investigators discretion
Previously untreated, histologically (or cytologically) confirmed diagnosis of primary B-cell lymphoma of the central nervous system (PCNSL) by local pathologist. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy
At least one measurable lesion
Serum creatinine estimated glomerular filtration rate (MDRD) ≥ 50 ml/min
Disqualifiers
Prior treatment for PCNSL with the exception of a pre-phase treatment comprising steroid treatment and / or single application of rituximab 375 mg/m² and methotrexate 3.5 g/m²
Systemic lymphoma manifestation outside the CNS
Diagnosis of previous Non-Hodgkin lymphoma at any time
Primary vitreoretinal or leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord
Trial design
Treatments tested in this trial
- Tafasitamab
- Lenalidomide
- Rituximab
- Methotrexate
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Cologne
Lead sponsor
Incyte Corporation
Collaborator
Source ClinicalTrials.gov