realMIND: Observational Study on Safety and Effectiveness of Tafasitamab in Combination With Lenalidomide in Patients With Relapsed or Refractory DLBCL
NCT ID: NCT04981795
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2021-09-20
2026-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Group 1: Racial and ethnic minority patients (at least 50 patients)
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)
Tafasitamab
Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide inPatients With Relapsed or Refractory DLBCL.
Interventions
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Tafasitamab
Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide inPatients With Relapsed or Refractory DLBCL.
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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John P Galvin, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Alabama Oncology
Birmingham, Alabama, United States
Clearview Cancer Institute
Huntsville, Alabama, United States
University of California, Irvine Medical Center
Orange, California, United States
McFarland Clinic P.C.
Ames, Iowa, United States
Mission Cancer and Blood
Des Moines, Iowa, United States
Tulane Cancer Center
New Orleans, Louisiana, United States
American Oncology Partners of Maryland PA
Bethesda, Maryland, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Morristown Medical Center
Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Westchester Medical Center
Hawthorne, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
VA Medical Center - Durham
Durham, North Carolina, United States
Leo Jenkins Cancer Center/ECU School of Medicine
Greenville, North Carolina, United States
Mercy Medical Center
Canton, Ohio, United States
Ohio Health Marion Area Physicians
Marion, Ohio, United States
Tri County Hematology & Oncology Associates, Inc
Massillon, Ohio, United States
Integris Cancer Institute of Oklahoma
Oklahoma City, Oklahoma, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
UW Medicine
Seattle, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
Froedtert & Medical College Clinics
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Daniel Contorno
Role: primary
Leslie Pauli
Role: primary
Yun-Pei (Alice) Ting
Role: primary
Chaney Phipps Phipps
Role: primary
Peggy Graham
Role: primary
Taylor Stutzman
Role: primary
Avery Polk
Role: primary
Tiffany Pearce
Role: primary
Maureen Nowakowski
Role: primary
Damayanti Bhavsar
Role: primary
Miles Jackson
Role: primary
Alicia Patrick
Role: primary
Jennifer Ordman
Role: primary
Denise Brigham
Role: primary
Taylor Duffy
Role: primary
Claire Limbert
Role: primary
Taylor Duffy
Role: primary
Kellie Larsen
Role: primary
Therese Manning
Role: primary
Ana Sanchez Cuellar
Role: primary
Sara Keshmiri
Role: primary
Beth Parker
Role: primary
Jiaxin Xing
Role: primary
References
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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.
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.
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.
Related Links
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realMIND: Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide in Patients With Relapsed or Refractory DLBCL (realMIND)
Other Identifiers
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MOR208C414
Identifier Type: -
Identifier Source: org_study_id