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Recruiting Phase 2 NCT05583071

Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL

Trial Parameters

Condition Non-Hodgkin Lymphoma
Sponsor University of Cologne
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age 99 Years
Start Date 2024-08-23
Completion 2027-02
Interventions
TafasitamabLenalidomideRituximab

Brief Summary

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

Inclusion Criteria: 1. Age 18-69 years with ECOG PS ≥2 or age ≥70 years, and ineligible for HCT-ASCT as per investigators discretion 2. 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 3. At least one measurable lesion 4. Adequate organ function: * Adequate kidney function, defined as: * Serum creatinine estimated glomerular filtration rate (MDRD) ≥ 50 ml/min * Adequate hepatic function, defined as: * ALAT and ASAT ≤ 3 ULN * Bilirubin ≤ 2.0 mg/dl (except for Meulengracht disease) * Adequate bone marrow function, defined as: * White blood cell (WBC) count ≥ 3000/µL or absolute neutrophil count (ANC) ≥ 1000/µL * Platelets ≥ 50.000/µL * Hemoglobin \> 8.0 g/dl * Adequate cardiac function, defined as: * Cardiac ejection fraction ≥ 40% * Adequate pulmonary function as per investi

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