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

April 22, 2026 updated by: Incyte Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Alabama Oncology
      • Huntsville, Alabama, United States, 35805
        • Clearview Cancer Institute
    • California
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic P.C.
      • Des Moines, Iowa, United States, 50309
        • Mission Cancer and Blood
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Cancer Center
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • American Oncology Partners of Maryland Pa
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center Michigan Medicine
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New Jersey
      • Morristown, New Jersey, United States, 07960-6136
        • Morristown Medical Center
      • New Brunswick, New Jersey, United States, 08903-2681
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Hawthorne, New York, United States, 10532
        • Westchester Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
      • Durham, North Carolina, United States, 27705
        • Duke University
      • Durham, North Carolina, United States, 27705
        • VA Medical Center - Durham
      • Greenville, North Carolina, United States, 27858
        • Leo Jenkins Cancer Center/ECU School of Medicine
    • Ohio
      • Canton, Ohio, United States, 44708
        • Mercy Medical Center
      • Marion, Ohio, United States, 43302
        • Ohio Health Marion Area Physicians
      • Massillon, Ohio, United States, 44646
        • Tri County Hematology & Oncology Associates, Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73142
        • Integris Cancer Institute of Oklahoma
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • UW Medicine
      • Yakima, Washington, United States, 98902
        • Yakima Valley Memorial Hospital/North Star Lodge
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert & Medical College Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Community Study- 40 sites across the USA

Description

Criteria: Inclusion Criteria:

  1. Age ≥18 years at the time of diagnosis of R/R DLBCL
  2. Initiated or initiating tafasitamab treatment
  3. R/R DLBCL patients who have received at least one (1) prior line of treatment for DLBCL

  4. Histologically confirmed DLBCL such as:

    a) DLBCL not otherwise specified (NOS) b) T-cell histiocyte-rich large B-cell lymphoma (THRLBCL) c) Epstein-Barr virus (EBV)-positive DLBCL of the elderly d) Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to Revised European American Lymphoma (REAL)/World Health Organization (WHO) classification e) Patients with evidence of histological transformation to DLBCL from an earlier diagnosis of low-grade lymphoma (i.e., an indolent pathology such as follicular lymphoma [FL], marginal zone lymphoma [MZL], chronic lymphocytic leukemia [CLL]) with a subsequent DLBCL relapse f) High-grade B-cell lymphoma: i) DLBCL with MYC and BCL2 or BCL6 translocation (double-hit) and MYC and BCL2 and BCL6 translocations (triple-hit) ii) High-grade B-cell lymphoma, NOS

  5. Signed and dated ICF by the patient or the patient's Legally Acceptable Representative (LAR), for patients with prospective data collection, as applicable. For deceased or otherwise unreachable patients, no informed consent will be obtained for data collection in the study, provided that the competent Independent Ethics Committee (IEC)/Institutional Review Board (IRB) has provided favorable opinion and that any other local regulatory requirements on this matter are met

Exclusion Criteria:

• Initiated or initiating tafasitamab treatment in the context of an interventional study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Group 1: Racial and ethnic minority patients (at least 50 patients)
Drug: Tafasitamab
Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide inPatients With Relapsed or Refractory DLBCL.
2
Group 2: Non Hispanic White (NHM) patients (at least 50 patients)
Drug: Tafasitamab
Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide inPatients With Relapsed or Refractory DLBCL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Patterns - Safety
Time Frame: 2 Years
Incidence and severity of Treatment-emergent serious AEs (SAEs) and AEs (TEAs)
2 Years
Treatment Patterns - Effectiveness (a)
Time Frame: 2 Years
Objective response rate (ORR)
2 Years
Treatment Patterns - Effectiveness (b)
Time Frame: 2 Years
Complete response (CR) rate
2 Years
Treatment Patterns - Effectiveness (c)
Time Frame: 2 Years
Duration of response (DoR)
2 Years
Treatment Patterns - Effectiveness (d)
Time Frame: 2 Years
OS
2 Years
Treatment Patterns - Effectiveness (e)
Time Frame: 2 Years
Progression-free survival (PFS)
2 Years
Treatment Patterns - Effectiveness (f)
Time Frame: 2 Years
Event-free survival (EFS)
2 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician-reported clinical outcome (a)
Time Frame: 2 Years
Number of treatment lines prior to receiving tafasitamab
2 Years
Physician-reported clinical outcome (b)
Time Frame: 2 Years
Distribution of treatment regimens by lines of therapy prior to and subsequent to tafasitamab treatment Duration of tafasitamab treatment (regardless of concomitant treatment with lenalidomide)
2 Years
Physician-reported clinical outcome (c)
Time Frame: 2 Years
Duration of combination treatment (i.e., duration of treatment with both tafasitamab and lenalidomide)
2 Years
Physician-reported clinical outcome (d)
Time Frame: 2 Years
Modifications of dose and treatment schedule of tafasitamab and/or lenalidomide
2 Years
Physician-reported clinical outcome (e)
Time Frame: 2 Years
Incidence of tafasitamab use with combination partners other than lenalidomide
2 Years
Physician-reported clinical outcome (f)
Time Frame: 2 Years
Incidence of tafasitamab use as monotherapy (i.e., without any combination partners)
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Collaborators

IQVIA Pty Ltd

Investigators

  • Study Director: John P Galvin, MD, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Actual)

January 23, 2026

Study Completion (Actual)

January 23, 2026

Study Registration Dates

First Submitted

July 19, 2021

First Submitted That Met QC Criteria

July 19, 2021

First Posted (Actual)

July 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOR208C414

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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