CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 654 enrolled
Drug / intervention
tafasitamab +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04680052
NCT04680052Phase 3Active
CompareCT.gov

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

Incyte Corporation·interventional·Posted Dec 22, 2020·Updated Dec 22, 2025

In Brief

A Phase 3 clinical trial evaluating tafasitamab, rituximab, and 2 other interventions for Follicular Lymphoma and Marginal Zone Lymphoma. Active but no longer recruiting, targeting 654 participants across 261 sites in 28 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFollicular Lymphoma, Marginal Zone Lymphoma
CountriesAustralia, 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, United States
Collaborators--

Timeline

Phase 3Active
20212022202320242025202620272028
First PostedDec 22, 2020
Enrollment StartApr 15, 2021
Primary CompletionFeb 23, 2024
Study CompletionAug 9, 2028
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.5 years ago

Interventions

tafasitamabdrug

tafasitamab will be administered IV for 12 cycles

rituximabdrug

Rituximab will be administered IV on cycles 1 - 5

lenalidomidedrug

Lenalidomide will be administered PO for 12 cycles

placebodrug

placebo will be administered IV for 12 cycles