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

Study Overview
=================
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.

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

Conditions
-----------------
Diffuse Large B-cell Lymphoma

Intervention / Treatment
-----------------
* Drug: Tafasitamab


Participation Criteria
=================
Eligibility Criteria
-----------------
Criteria: Inclusion Criteria: 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 Exclusion Criteria: • Initiated or initiating tafasitamab treatment in the context of an interventional study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Group 1: Racial and ethnic minority patients (at least 50 patients) | Drug: Tafasitamab<br>* Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide inPatients With Relapsed or Refractory DLBCL.<br>|
| 2<br>Group 2: Non Hispanic White (NHM) patients (at least 50 patients) | Drug: Tafasitamab<br>* Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide inPatients With Relapsed or Refractory DLBCL.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Patterns - Safety | Incidence and severity of Treatment-emergent serious AEs (SAEs) and AEs (TEAs) | 2 Years | 
| Treatment Patterns - Effectiveness (a) | Objective response rate (ORR) | 2 Years | 
| Treatment Patterns - Effectiveness (b) | Complete response (CR) rate | 2 Years | 
| Treatment Patterns - Effectiveness (c) | Duration of response (DoR) | 2 Years | 
| Treatment Patterns - Effectiveness (d) | OS | 2 Years | 
| Treatment Patterns - Effectiveness (e) | Progression-free survival (PFS) | 2 Years | 
| Treatment Patterns - Effectiveness (f) | Event-free survival (EFS) | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician-reported clinical outcome (a) | Number of treatment lines prior to receiving tafasitamab | 2 Years | 
| Physician-reported clinical outcome (b) | 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) | 2 Years | 
| Physician-reported clinical outcome (c) | Duration of combination treatment (i.e., duration of treatment with both tafasitamab and lenalidomide) | 2 Years | 
| Physician-reported clinical outcome (d) | Modifications of dose and treatment schedule of tafasitamab and/or lenalidomide | 2 Years | 
| Physician-reported clinical outcome (e) | Incidence of tafasitamab use with combination partners other than lenalidomide | 2 Years | 
| Physician-reported clinical outcome (f) | Incidence of tafasitamab use as monotherapy (i.e., without any combination partners) | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DLBCL, Lymphoma