Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL

Sponsor
University of Cologne
Study ID
NCT05583071
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in patients ineligible for HCT-ASCT with Primary Central Nervous System Lymphoma (PCNSL)

Key Dates

Start date
Aug 23, 2024
Status verified
Apr 2025
Primary completion
Feb 28, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: combination of Tafasitamab (Minjuvi®), Lenalidomide, Rituximab and Methotrexate
    All patients will receive tafasitamab (Minjuvi®) 12 mg/KG body weight and rituximab 375 mg/m² on days 0 and 5, followed by methotrexate 3,5 g/m² on day 1 as an intravenous infusion. Lenalidomide will be administered orally at 20 mg/day during the first cycle and at 25 mg/day during subsequent cycles on days 4-17 of each 21-day cycle for a total number of 4 cycles. The treatment duration per patient will be 84 days.

Primary Outcome Measure

complete response rate (CRR) [ Time Frame: At the end of cycle 2 (each cycle is 21 days) ]

Central Contacts

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