A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

• Status: Recruiting
• Trial end date: 2028-08-04
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Lenalidomide; Rituximab

Criteria

Inclusion Criteria:

• Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL

• Willingness to avoid pregnancy or fathering children

• In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin)

• Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy

• Documented relapsed, refractory, or PD after treatment with systemic therapy

• ECOG performance status of 0 to 2

Exclusion Criteria:

• Women who are pregnant or breastfeeding.

• Any histology other than FL and MZL or clinical evidence of transformed lymphoma

• Prior non-hematologic malignancy

• Congestive heart failure

• HCV positivity, chronic HBV infection or history of HIV infection

• Active systemic infection

• CNS lymphoma involvement

• Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1

• Prior use of lenalidomide in combination with rituximab