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Diffuse Large B-cell LymphomarealMINDNCT04981795

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

An observational study of Diffuse Large B-cell Lymphoma, run by Incyte Corporation at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-cell Lymphoma
What is being tested?
Tafasitamab
How many people
102 participants
Where
26 sitesUnited States
Study dates
20 Sep 2021to 23 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Community Study- 40 sites across the USA

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • McFarland Clinic P.C.

    Ames, Iowa, 50010

  • University of Michigan Comprehensive Cancer Center Michigan Medicine

    Ann Arbor, Michigan, 48109

  • American Oncology Partners of Maryland PA

    Bethesda, Maryland, 20817

  • Alabama Oncology

    Birmingham, Alabama, 35211

  • Mercy Medical Center

    Canton, Ohio, 44708

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Mission Cancer and Blood

    Des Moines, Iowa, 50309

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University

    Durham, North Carolina, 27705

  • VA Medical Center - Durham

    Durham, North Carolina, 27705

  • Leo Jenkins Cancer Center/ECU School of Medicine

    Greenville, North Carolina, 27858

  • Westchester Medical Center

    Hawthorne, New York, 10532

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • Ohio Health Marion Area Physicians

    Marion, Ohio, 43302

  • Tri County Hematology & Oncology Associates, Inc

    Massillon, Ohio, 44646

  • Froedtert & Medical College Clinics

    Milwaukee, Wisconsin, 53226

  • Morristown Medical Center

    Morristown, New Jersey, 07960-6136

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903-2681

  • Tulane Cancer Center

    New Orleans, Louisiana, 70112

  • Integris Cancer Institute of Oklahoma

    Oklahoma City, Oklahoma, 73142

  • University of California, Irvine Medical Center

    Orange, California, 92868

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • UW Medicine

    Seattle, Washington, 98109

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • Yakima Valley Memorial Hospital/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: 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.

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.
Being tested
Tafasitamab
Keywords
DLBCL, Lymphoma
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TafasitamabDrug

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

Study groups in NCT04981795
Study groupRoleWhat they receive
1Group 1: Racial and ethnic minority patients (at least 50 patients)
Receives: Drug: Tafasitamab
2Group 2: Non Hispanic White (NHM) patients (at least 50 patients)
Receives: Drug: Tafasitamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment Patterns - Safety

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

    Measured: 2 Years

  2. Treatment Patterns - Effectiveness (a)

    Objective response rate (ORR)

    Measured: 2 Years

  3. Treatment Patterns - Effectiveness (b)

    Complete response (CR) rate

    Measured: 2 Years

  4. Treatment Patterns - Effectiveness (c)

    Duration of response (DoR)

    Measured: 2 Years

  5. Treatment Patterns - Effectiveness (d)

    OS

    Measured: 2 Years

  6. Treatment Patterns - Effectiveness (e)

    Progression-free survival (PFS)

    Measured: 2 Years

  7. Treatment Patterns - Effectiveness (f)

    Event-free survival (EFS)

    Measured: 2 Years

Secondary outcomes (6)

  1. Physician-reported clinical outcome (a)

    Number of treatment lines prior to receiving tafasitamab

    Measured: 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)

    Measured: 2 Years

  3. Physician-reported clinical outcome (c)

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

    Measured: 2 Years

  4. Physician-reported clinical outcome (d)

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

    Measured: 2 Years

  5. Physician-reported clinical outcome (e)

    Incidence of tafasitamab use with combination partners other than lenalidomide

    Measured: 2 Years

  6. Physician-reported clinical outcome (f)

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

    Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2021
  2. Study start20 Sep 2021
  3. Primary completion23 Jan 2026
  4. Study completion23 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04981795
Sponsor's protocol ID
MOR208C414
Acronym
realMIND
Status last verified
Apr 2026
First submitted
19 Jul 2021
Last updated
27 Apr 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Diffuse Large B-cell Lymphoma, run by Incyte Corporation at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Patterns - Safety (time frame: 2 Years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04981795, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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