realMIND: Observational Study on Safety and Effectiveness of Tafasitamab in Combination With Lenalidomide in Patients With Relapsed or Refractory DLBCL
- Registration Number
- NCT04981795
- Lead Sponsor
- Incyte Corporation
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
-
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
• Initiated or initiating tafasitamab treatment in the context of an interventional study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Tafasitamab Group 1: Racial and ethnic minority patients (at least 50 patients) 2 Tafasitamab Group 2: Non Hispanic White (NHM) patients (at least 50 patients)
- Primary Outcome Measures
Name Time Method Treatment Patterns - Effectiveness (a) 2 Years Objective response rate (ORR)
Treatment Patterns - Effectiveness (c) 2 Years Duration of response (DoR)
Treatment Patterns - Effectiveness (e) 2 Years Progression-free survival (PFS)
Treatment Patterns - Safety 2 Years Incidence and severity of Treatment-emergent serious AEs (SAEs) and AEs (TEAs)
Treatment Patterns - Effectiveness (d) 2 Years OS
Treatment Patterns - Effectiveness (b) 2 Years Complete response (CR) rate
Treatment Patterns - Effectiveness (f) 2 Years Event-free survival (EFS)
- Secondary Outcome Measures
Name Time Method Physician-reported clinical outcome (c) 2 Years Duration of combination treatment (i.e., duration of treatment with both tafasitamab and lenalidomide)
Physician-reported clinical outcome (a) 2 Years Number of treatment lines prior to receiving tafasitamab
Physician-reported clinical outcome (b) 2 Years Distribution of treatment regimens by lines of therapy prior to and subsequent to tafasitamab treatment Duration of tafasitamab treatment (regardless of concomitant treatment with lenalidomide)
Physician-reported clinical outcome (e) 2 Years Incidence of tafasitamab use with combination partners other than lenalidomide
Physician-reported clinical outcome (d) 2 Years Modifications of dose and treatment schedule of tafasitamab and/or lenalidomide
Physician-reported clinical outcome (f) 2 Years Incidence of tafasitamab use as monotherapy (i.e., without any combination partners)
Trial Locations
- Locations (25)
University of California, Irvine Medical Center
🇺🇸Orange, California, United States
Alabama Oncology
🇺🇸Birmingham, Alabama, United States
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, 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