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CompletedNCT04981795realMINDUpdated Apr 27, 2026

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

An observational study in Diffuse Large B-cell Lymphoma, sponsored by Incyte Corporation. Completed at 26 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.

Sponsored by Incyte Corporation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
102
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.
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Conditions studied

  • Diffuse Large B-cell Lymphoma

Keywords

  • DLBCL
  • Lymphoma
03

In context

Lymphoma, Large B-Cell, Diffuse

1,390 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 350 are open to participants now.

This study's enrollment of 102 is below the median of 153 across 150 observational studies indexed under Lymphoma, Large B-Cell, Diffuse.

Browse Lymphoma, Large B-Cell, Diffuse studies →

Lead sponsor

Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.

Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Community Study- 40 sites across the USA

Eligibility 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
102 participants (actual)
Patient registry
No

Groups and cohorts

  • 1

    Group 1: Racial and ethnic minority patients (at least 50 patients)

    Drug: Tafasitamab

  • 2

    Group 2: Non Hispanic White (NHM) patients (at least 50 patients)

    Drug: Tafasitamab

Interventions

  • DrugTafasitamab

    Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide inPatients With Relapsed or Refractory DLBCL.

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What researchers measure

Primary outcomes

  1. Treatment Patterns - Safety

    Incidence and severity of Treatment-emergent serious AEs (SAEs) and AEs (TEAs)

    Time frame: 2 Years

  2. Treatment Patterns - Effectiveness (a)

    Objective response rate (ORR)

    Time frame: 2 Years

  3. Treatment Patterns - Effectiveness (b)

    Complete response (CR) rate

    Time frame: 2 Years

  4. Treatment Patterns - Effectiveness (c)

    Duration of response (DoR)

    Time frame: 2 Years

  5. Treatment Patterns - Effectiveness (d)

    OS

    Time frame: 2 Years

  6. Treatment Patterns - Effectiveness (e)

    Progression-free survival (PFS)

    Time frame: 2 Years

  7. Treatment Patterns - Effectiveness (f)

    Event-free survival (EFS)

    Time frame: 2 Years

Secondary outcomes

  1. Physician-reported clinical outcome (a)

    Number of treatment lines prior to receiving tafasitamab

    Time frame: 2 Years

  2. Physician-reported clinical outcome (b)

    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)

    Time frame: 2 Years

  3. Physician-reported clinical outcome (c)

    Duration of combination treatment (i.e., duration of treatment with both tafasitamab and lenalidomide)

    Time frame: 2 Years

  4. Physician-reported clinical outcome (d)

    Modifications of dose and treatment schedule of tafasitamab and/or lenalidomide

    Time frame: 2 Years

  5. Physician-reported clinical outcome (e)

    Incidence of tafasitamab use with combination partners other than lenalidomide

    Time frame: 2 Years

  6. Physician-reported clinical outcome (f)

    Incidence of tafasitamab use as monotherapy (i.e., without any combination partners)

    Time frame: 2 Years

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Study locations

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

Publications

  • Salles G, Duell J, Gonzalez Barca E, Tournilhac O, Jurczak W, Liberati AM, Nagy Z, Obr A, Gaidano G, Andre M, Kalakonda N, Dreyling M, Weirather J, Dirnberger-Hertweck M, Ambarkhane S, Fingerle-Rowson G, Maddocks K. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. doi: 10.1016/S1470-2045(20)30225-4. Epub 2020 Jun 5. PubMed 32511983 ↗
  • Duell J, Maddocks KJ, Gonzalez-Barca E, Jurczak W, Liberati AM, De Vos S, Nagy Z, Obr A, Gaidano G, Abrisqueta P, Kalakonda N, Andre M, Dreyling M, Menne T, Tournilhac O, Augustin M, Rosenwald A, Dirnberger-Hertweck M, Weirather J, Ambarkhane S, Salles G. Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2417-2426. doi: 10.3324/haematol.2020.275958. PubMed 34196165 ↗
  • Duell J, Abrisqueta P, Andre M, Gaidano G, Gonzales-Barca E, Jurczak W, Kalakonda N, Liberati AM, Maddocks KJ, Menne T, Nagy Z, Tournilhac O, Kuffer C, Bakuli A, Amin A, Gurbanov K, Salles G. Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety findings in the phase II L-MIND study. Haematologica. 2024 Feb 1;109(2):553-566. doi: 10.3324/haematol.2023.283480. PubMed 37646664 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04981795
Lead sponsor
Incyte Corporation
Responsible party
Sponsor
First posted
Jul 29, 2021
Start date
Sep 20, 2021
Primary completion
Jan 23, 2026
Completion
Jan 23, 2026
Last update
Apr 27, 2026

Study contacts

John P Galvin, MD
study director · Incyte Corporation

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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