The study follows a Simon's two-stage phase II trial design to evaluate the safety and efficacy of tafasitamab added to rituximab and lenalidomide for two treatment-naïve, parallel, independent cohorts: follicular lymphoma (FL) and marginal zone lymphoma (MZ). Each cohort, FL and MZ, will be evaluated separately. This study is presented to the patient and consent is signed prior to the initiation of treatment for their primary malignancy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22.
Rituximab 375 mg/m2 IV on day 1
Lenalidomide 20 mg PO Day 1 through Day 21
Masonic Cancer Center
Minneapolis, Minnesota, United States
RECRUITINGComplete response (CR)
Estimate complete response (CR) at the end of study (after 12 cycles around 1 year) regimen of tafasitamab with lenalidomide and rituximab.
Time frame: 1 year
Complete response (CR)
Estimate complete response (CR) rate after 6 cycles of treatment.
Time frame: 6 months
Overall response rate (ORR)
Estimate overall response rate (ORR) at the end of treatment (around 1 year).
Time frame: 1 year
Progression of disease (POD24)
Estimate progression of disease (POD24) within 24 months (2 years)
Time frame: 2 years
Progression free survival (PFS)
Estimate progression free survival (PFS) at 3 years after registration on study
Time frame: 3 years
Overall survival (OS)
Estimate overall survival (OS) at 3 years after registration on study
Time frame: 3 years
Rate of histologic conversion to DLBCL
Estimate rate of histologic conversion to DLBCL at any point on study.
Time frame: 3 years
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