HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasonic Cancer Center, University of Minnesota
About this trial
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.
Eligibility criteria
Qualifiers
Histologically confirmed marginal zone lymphoma
Histologically confirmed CD20+ follicular lymphoma stage 1, 2 or 3a
No prior systemic therapy for lymphoma
a nodal or extranodal (except spleen) mass >7cm in its greater diameter or,
Disqualifiers
HBV surface antigen (HBsAg) positive
HBV surface antigen (HBsAg) negative, HBV surface antibody (anti-HBs) positive and/or HBV core antibody (anti-HBc) positive, and detectable viral DNA
Hepatitis C virus (HCV) positive subjects with chronic hepatitis C, or subjects with an active hepatitis C infection requiring anti-viral medication (at time of randomization).
Known seropositive for or active viral infection with human immunodeficiency virus (HIV).
Trial design
Treatments tested in this trial
- Tafasitamab
- Rituximab
- Lenalidomide
Treatment groups
65 Participants
are divided into 2 treatment groupsSponsors and collaborators
Masonic Cancer Center, University of Minnesota
Lead sponsor
Incyte Corporation
Collaborator
Source ClinicalTrials.gov