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

NCT04981795 | Completed FDA Drug

• 1 other identifier: MOR208C414
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 26

Brief 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.

Conditions

Diffuse Large B-cell Lymphoma

Keywords

DLBCL; Lymphoma

Outcome Measures

Primary Outcomes (7)

• Treatment Patterns - Safety

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

  2 Years

• Treatment Patterns - Effectiveness (a)

  Objective response rate (ORR)

  2 Years

• Treatment Patterns - Effectiveness (b)

  Complete response (CR) rate

  2 Years

• Treatment Patterns - Effectiveness (c)

  Duration of response (DoR)

  2 Years

• Treatment Patterns - Effectiveness (d)

  OS

  2 Years

• Treatment Patterns - Effectiveness (e)

  Progression-free survival (PFS)

  2 Years

• Treatment Patterns - Effectiveness (f)

  Event-free survival (EFS)

  2 Years

Secondary Outcomes (6)

• Physician-reported clinical outcome (a)

  2 Years

• Physician-reported clinical outcome (b)

  2 Years

• Physician-reported clinical outcome (c)

  2 Years

• Physician-reported clinical outcome (d)

  2 Years

• Physician-reported clinical outcome (e)

  2 Years

Study Arms (2)

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

Tafasitamab DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community Study- 40 sites across the USA

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (26)

Alabama Oncology

Birmingham, Alabama, 35211, United States

Location

Clearview Cancer Institute

Huntsville, Alabama, 35805, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

McFarland Clinic P.C.

Ames, Iowa, 50010, United States

Location

Mission Cancer and Blood

Des Moines, Iowa, 50309, United States

Location

Tulane Cancer Center

New Orleans, Louisiana, 70112, United States

Location

American Oncology Partners of Maryland PA

Bethesda, Maryland, 20817, United States

Location

University of Michigan Comprehensive Cancer Center Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960-6136, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903-2681, United States

Location

Westchester Medical Center

Hawthorne, New York, 10532, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

VA Medical Center - Durham

Durham, North Carolina, 27705, United States

Location

Leo Jenkins Cancer Center/ECU School of Medicine

Greenville, North Carolina, 27858, United States

Location

Mercy Medical Center

Canton, Ohio, 44708, United States

Location

Ohio Health Marion Area Physicians

Marion, Ohio, 43302, United States

Location

Tri County Hematology & Oncology Associates, Inc

Massillon, Ohio, 44646, United States

Location

Integris Cancer Institute of Oklahoma

Oklahoma City, Oklahoma, 73142, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

UW Medicine

Seattle, Washington, 98109, United States

Location

Yakima Valley Memorial Hospital/North Star Lodge

Yakima, Washington, 98902, United States

Location

Froedtert & Medical College Clinics

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• 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.

  PMID: 32511983 BACKGROUND

• 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.

  PMID: 34196165 BACKGROUND

• 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.

  PMID: 37646664 BACKGROUND

Related Links

• realMIND: Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide in Patients With Relapsed or Refractory DLBCL (realMIND)

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma

Interventions

tafasitamab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• John P Galvin, MD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 29, 2021
• Study Start: September 20, 2021
• Primary Completion: January 23, 2026
• Study Completion: January 23, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (26)