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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Group 1: Racial and ethnic minority patients (at least 50 patients) |
| |
| 2 | Group 2: Non Hispanic White (NHM) patients (at least 50 patients) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafasitamab | Drug | Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide inPatients With Relapsed or Refractory DLBCL. |
|
| 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 |
| 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) |
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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.
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Community Study- 40 sites across the USA
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| Name | Affiliation | Role |
|---|---|---|
| John P Galvin, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Oncology | Birmingham | Alabama | 35211 | United States | ||
| Clearview Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32511983 | Background | Salles G, Duell J, Gonzalez Barca E, Tournilhac O, Jurczak W, Liberati AM, Nagy Z, Obr A, Gaidano G, Andre M, Kalakonda N, Dreyling M, Weirather J, Dirnberger-Hertweck M, Ambarkhane S, Fingerle-Rowson G, Maddocks K. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. doi: 10.1016/S1470-2045(20)30225-4. Epub 2020 Jun 5. | |
| 34196165 |
| Label | URL |
|---|---|
| realMIND: Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide in Patients With Relapsed or Refractory DLBCL (realMIND) | View source |
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| 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 |
| 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 |
| Duke University | Durham | North Carolina | 27705 | 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 |
| Background |
| Duell J, Maddocks KJ, Gonzalez-Barca E, Jurczak W, Liberati AM, De Vos S, Nagy Z, Obr A, Gaidano G, Abrisqueta P, Kalakonda N, Andre M, Dreyling M, Menne T, Tournilhac O, Augustin M, Rosenwald A, Dirnberger-Hertweck M, Weirather J, Ambarkhane S, Salles G. Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2417-2426. doi: 10.3324/haematol.2020.275958. |
| 37646664 | Background | Duell J, Abrisqueta P, Andre M, Gaidano G, Gonzales-Barca E, Jurczak W, Kalakonda N, Liberati AM, Maddocks KJ, Menne T, Nagy Z, Tournilhac O, Kuffer C, Bakuli A, Amin A, Gurbanov K, Salles G. Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety findings in the phase II L-MIND study. Haematologica. 2024 Feb 1;109(2):553-566. doi: 10.3324/haematol.2023.283480. |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000613469 | tafasitamab |
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