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

Last updated: December 5, 2024
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hematologic Cancer

Lymphoma, B-cell

Lymphoma

Treatment

Tafasitamab

Clinical Study ID

NCT04981795
MOR208C414
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 forDLBCL

  4. Histologically confirmed DLBCL such as: a) DLBCL not otherwise specified (NOS) b) T-cell histiocyte-rich large B-celllymphoma (THRLBCL) c) Epstein-Barr virus (EBV)-positive DLBCL of the elderly d)Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, accordingto Revised European American Lymphoma (REAL)/World Health Organization (WHO)classification e) Patients with evidence of histological transformation to DLBCLfrom an earlier diagnosis of low-grade lymphoma (i.e., an indolent pathology such asfollicular lymphoma [FL], marginal zone lymphoma [MZL], chronic lymphocytic leukemia [CLL]) with a subsequent DLBCL relapse f) High-grade B-cell lymphoma: i) DLBCL withMYC and BCL2 or BCL6 translocation (double-hit) and MYC and BCL2 and BCL6translocations (triple-hit) ii) High-grade B-cell lymphoma, NOS

  5. Signed and dated ICF by the patient or the patient's Legally AcceptableRepresentative (LAR), for patients with prospective data collection, as applicable.For deceased or otherwise unreachable patients, no informed consent will be obtainedfor data collection in the study, provided that the competent Independent EthicsCommittee (IEC)/Institutional Review Board (IRB) has provided favorable opinion andthat any other local regulatory requirements on this matter are met

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Tafasitamab
Phase:
Study Start date:
September 20, 2021
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • Alabama Oncology

    Birmingham, Alabama 35211
    United States

    Active - Recruiting

  • Clearview Cancer Institute

    Huntsville, Alabama 35805
    United States

    Active - Recruiting

  • California Cancer Associates for Research & Excellence, Inc. - Escondido

    Escondido, California 92025
    United States

    Site Not Available

  • University of California, Irvine Medical Center

    Orange, California 92868
    United States

    Active - Recruiting

  • Solano Hematology

    Vallejo, California 94589
    United States

    Site Not Available

  • Comprehensive Hematology Oncology

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

  • Orchard Healthcare Research Inc.

    Skokie, Illinois 60077
    United States

    Site Not Available

  • McFarland Clinic P.C.

    Ames, Iowa 50010
    United States

    Active - Recruiting

  • Mission Cancer and Blood

    Des Moines, Iowa 50309
    United States

    Active - Recruiting

  • Tulane Cancer Center

    New Orleans, Louisiana 70112
    United States

    Completed

  • Willis-Knighton Cancer Center

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • American Oncology Partners of Maryland PA

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Berkshire Hematology Oncology, PC

    Pittsfield, Massachusetts 01201
    United States

    Site Not Available

  • University of Michigan Comprehensive Cancer Center Michigan Medicine

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Morristown Medical Center

    Morristown, New Jersey 07960-6136
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08903-2681
    United States

    Active - Recruiting

  • Westchester Medical Center

    Hawthorne, New York 10532
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • VA Medical Center - Durham

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Leo Jenkins Cancer Center/ECU School of Medicine

    Greenville, North Carolina 27858
    United States

    Active - Recruiting

  • Mercy Medical Center

    Canton, Ohio 44708
    United States

    Active - Recruiting

  • Ohio Health Marion Area Physicians

    Marion, Ohio 43302
    United States

    Active - Recruiting

  • Tri County Hematology & Oncology Associates, Inc

    Massillon, Ohio 44646
    United States

    Active - Recruiting

  • Integris Cancer Institute of Oklahoma

    Oklahoma City, Oklahoma 73142
    United States

    Active - Recruiting

  • Good Samaritan Hospital, Corvallis

    Corvallis, Oregon 97330
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Lankenau Medical Center

    Wynnewood, Pennsylvania 19096
    United States

    Completed

  • South Carolina Cancer Specialists

    Hilton Head Island, South Carolina 29926
    United States

    Site Not Available

  • BSA Harrington Cancer Center

    Amarillo, Texas 79106
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Renovatio Clinical

    The Woodlands, Texas 77380
    United States

    Site Not Available

  • UW Medicine

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • MultiCare Health System Institute for Research and Innovation

    Spokane, Washington 99218
    United States

    Site Not Available

  • Yakima Valley Memorial Hospital/North Star Lodge

    Yakima, Washington 98902
    United States

    Active - Recruiting

  • Froedtert & Medical College Clinics

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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