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

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Alabama Oncology
RECRUITING
Birmingham
Clearview Cancer Institute
RECRUITING
Huntsville
California
University of California, Irvine Medical Center
RECRUITING
Orange
Iowa
McFarland Clinic P.C.
RECRUITING
Ames
Mission Cancer and Blood
RECRUITING
Des Moines
Louisiana
Tulane Cancer Center
COMPLETED
New Orleans
Maryland
American Oncology Partners of Maryland PA
RECRUITING
Bethesda
Michigan
University of Michigan Comprehensive Cancer Center Michigan Medicine
RECRUITING
Ann Arbor
Henry Ford Health System
RECRUITING
Detroit
North Carolina
Levine Cancer Institute
RECRUITING
Charlotte
VA Medical Center - Durham
RECRUITING
Durham
Leo Jenkins Cancer Center/ECU School of Medicine
RECRUITING
Greenville
New Jersey
Morristown Medical Center
RECRUITING
Morristown
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
New York
Westchester Medical Center
RECRUITING
Hawthorne
Ohio
Mercy Medical Center
RECRUITING
Canton
Ohio Health Marion Area Physicians
RECRUITING
Marion
Tri County Hematology & Oncology Associates, Inc
RECRUITING
Massillon
Oklahoma
Integris Cancer Institute of Oklahoma
RECRUITING
Oklahoma City
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Lankenau Medical Center
COMPLETED
Wynnewood
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Washington
UW Medicine
RECRUITING
Seattle
Yakima Valley Memorial Hospital/North Star Lodge
RECRUITING
Yakima
Wisconsin
Froedtert & Medical College Clinics
RECRUITING
Milwaukee
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Time Frame
Start Date: 2021-09-20
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 100
Treatments
1
Group 1: Racial and ethnic minority patients (at least 50 patients)
2
Group 2: Non Hispanic White (NHM) patients (at least 50 patients)
Sponsors
Leads: Incyte Corporation

This content was sourced from clinicaltrials.gov