NCT04680052

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.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 654 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Follicular Lymphoma
• Marginal Zone Lymphoma

Interventions

Type	Name	Description
DRUG	tafasitamab	tafasitamab will be administered IV for 12 cycles
DRUG	rituximab	Rituximab will be administered IV on cycles 1 - 5
DRUG	lenalidomide	Lenalidomide will be administered PO for 12 cycles
DRUG	placebo	placebo will be administered IV for 12 cycles

Timeline

• Start date: 2021-04-15
• Primary completion: 2024-02-23
• Completion: 2028-08-09
• First posted: 2020-12-22
• Last updated: 2025-12-22
• Results posted: 2025-04-04

Locations

261 sites across 28 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study