NCT05222555

Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients

A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Tafasitamab	tafasitamab will be administered intravenously at protocol defined timepoints
DRUG	Lenalidomide	lenalidomide will be administered orally at protocol defined timepoints

Timeline

• Start date: 2022-07-19
• Primary completion: 2024-07-17
• Completion: 2027-11-30
• First posted: 2022-02-03
• Last updated: 2026-01-16
• Results posted: 2025-07-28

Locations

62 sites across 9 countries: United States, Austria, Czechia, France, Israel, Italy, Poland, South Korea, Spain

Regulatory

• FDA-regulated drug study