NCT04981795

realMIND: Observational Study on Safety and Effectiveness of Tafasitamab in Combination With Lenalidomide in Patients With Relapsed or Refractory DLBCL

realMIND: A Multicenter, Observational Study to Characterize the Safety and Effectiveness of Tafasitamab in Combination With Lenalidomide in US Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma With a Focus on Racial and Ethnic Minority Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The realMIND study is a multicenter, observational study intended to further characterize the safety and effectiveness data of US patients (with a focus on racial and ethnic minority patients) with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), treated with tafasitamab in combination with lenalidomide.

Detailed description

This observational study is intended to further characterize the safety and effectiveness of tafasitamab, in combination with lenalidomide, in patients with R/R DLBCL in the US, with a focus on racial and ethnic minorities. This study also characterizes the overall treatment patterns (e.g., line of treatment, dose modification, combination partners, use as monotherapy) of US patients with R/R DLBCL who have been treated with tafasitamab with a focus on racial and ethnic minorities This multicenter real-world study will help to characterize the use of tafasitamab (e.g., line of treatment, dose modification, combination partners, use as monotherapy) among US patients with R/R DLBCL with a focus on racial and ethnic minorities This is an observational study; as such, no study visits or assessments, laboratory tests or procedures are mandated by the study. Patients will be evaluated and treated according to the physician's usual practice and discretion. Patient data for this observational study will be collected in one of two ways; either * by prospective follow-up of patients included at study sites, or * by retrospective collection of data from patient records, at study sites or from vendor databases.

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Tafasitamab	Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide inPatients With Relapsed or Refractory DLBCL.

Timeline

• Start date: 2021-09-20
• Primary completion: 2025-10-31
• Completion: 2026-08-31
• First posted: 2021-07-29
• Last updated: 2024-12-10

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study