Home › Trials › NCT04981795

Observational study on tafasitamab and lenalidomide for relapsed 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

Incyte Corporation · NCT04981795

This study is testing how well a combination of tafasitamab and lenalidomide works for people with relapsed diffuse large B-cell lymphoma, especially focusing on the experiences of racial and ethnic minorities.

Quick facts

Study typeObservational
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorIncyte Corporation (industry)
Drugs / interventionstafasitamab
Locations25 sites (Birmingham, Alabama and 24 other locations)
Trial IDNCT04981795 on ClinicalTrials.gov

What this trial studies

The realMIND study is a multicenter observational study aimed at evaluating the safety and effectiveness of tafasitamab in combination with lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This study focuses on collecting data from US patients, particularly racial and ethnic minorities, to better understand treatment patterns and outcomes. Patient data will be gathered through prospective follow-up or retrospective record collection, allowing for insights into real-world treatment experiences without mandated study visits or assessments.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of relapsed or refractory DLBCL who are initiating treatment with tafasitamab.

Not a fit: Patients who have not received prior treatment for DLBCL or those with other types of lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into effective treatment options for patients with relapsed or refractory DLBCL, particularly among minority populations.

How similar studies have performed: Other studies have shown promise in evaluating the effectiveness of tafasitamab, making this approach relevant and potentially impactful.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Diffuse Large B-cell Lymphoma, DLBCL, Lymphoma

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.