RECRUITING

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

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Conditions

Diffuse Large B-cell LymphomaDLBCLLymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-09-20
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04981795

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥18 years at the time of diagnosis of R/R DLBCL
  2. 2. Initiated or initiating tafasitamab treatment
  3. 3. R/R DLBCL patients who have received at least one (1) prior line of treatment for DLBCL
  4. 4. Histologically confirmed DLBCL such as:
  5. 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
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Incyte Corporation Call Center (US)
CONTACT
1.855.463.3463
medinfo@incyte.com

Principal Investigator

John P Galvin, MD
STUDY_DIRECTOR
Incyte Corporation

Study Locations (Sites)

Alabama Oncology
Birmingham, Alabama, 35211
United States
Clearview Cancer Institute
Huntsville, Alabama, 35805
United States
University of California, Irvine Medical Center
Orange, California, 92868
United States
McFarland Clinic P.C.
Ames, Iowa, 50010
United States
Mission Cancer and Blood
Des Moines, Iowa, 50309
United States
Tulane Cancer Center
New Orleans, Louisiana, 70112
United States
American Oncology Partners of Maryland PA
Bethesda, Maryland, 20817
United States
University of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor, Michigan, 48109
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Morristown Medical Center
Morristown, New Jersey, 07960-6136
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903-2681
United States
Westchester Medical Center
Hawthorne, New York, 10532
United States
Levine Cancer Institute
Charlotte, North Carolina, 28204
United States
VA Medical Center - Durham
Durham, North Carolina, 27705
United States
Leo Jenkins Cancer Center/ECU School of Medicine
Greenville, North Carolina, 27858
United States
Mercy Medical Center
Canton, Ohio, 44708
United States
Ohio Health Marion Area Physicians
Marion, Ohio, 43302
United States
Tri County Hematology & Oncology Associates, Inc
Massillon, Ohio, 44646
United States
Integris Cancer Institute of Oklahoma
Oklahoma City, Oklahoma, 73142
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
UW Medicine
Seattle, Washington, 98109
United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902
United States
Froedtert & Medical College Clinics
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Incyte Corporation

  • John P Galvin, MD, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-20
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2021-09-20
Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

  • DLBCL
  • Lymphoma

Additional Relevant MeSH Terms

  • Diffuse Large B-cell Lymphoma