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.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicentre 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

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.

Trial Description

Primary Outcome:

• Progression Free Survival (PFS) in FL population

• Progression Free Survival (PFS) in FL and MZL populations
• Complete Response in FL population
• Minimal Residual Disease-negativity rate in FL and MZL Population
• Overall Survival in FL Population
• Complete Response in Overall population
• Overall Survival in overall Population
• Best Overall Response Rate in FL and overall population
• Duration of Response in FL and overall population
• Quality-of-Life Assessments in FL and overall populations
• Safety: Number of participants with TEAE's

View this trial on ClinicalTrials.gov