Clinical trial NCT04981795: realMIND: Observational Study on Safety and Effectiveness of Tafasitamab in Combination With Lenalidomide in Patients With Relapsed or Refractory DLBCL
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diffuse Large B-cell Lymphoma
Keywords: DLBCL
Lymphoma
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community Study- 40 sites across the USA

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.

Eligibility criteria: Criteria: Inclusion Criteria:

1. Age ≥18 years at the time of diagnosis of R/R DLBCL
2. Initiated or initiating tafasitamab treatment
3. R/R DLBCL patients who have received at least one (1) prior line of treatment for DLBCL
4. 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
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

Exclusion Criteria:

• Initiated or initiating tafasitamab treatment in the context of an interventional study.

Primary outcomes:
measure: Treatment Patterns - Safety
timeFrame: 2 Years
measure: Treatment Patterns - Effectiveness (a)
timeFrame: 2 Years
measure: Treatment Patterns - Effectiveness (b)
timeFrame: 2 Years
measure: Treatment Patterns - Effectiveness (c)
timeFrame: 2 Years
measure: Treatment Patterns - Effectiveness (d)
timeFrame: 2 Years
measure: Treatment Patterns - Effectiveness (e)
timeFrame: 2 Years
measure: Treatment Patterns - Effectiveness (f)
timeFrame: 2 Years
Secondary outcomes:
measure: Physician-reported clinical outcome (a)
timeFrame: 2 Years
measure: Physician-reported clinical outcome (b)
timeFrame: 2 Years
measure: Physician-reported clinical outcome (c)
timeFrame: 2 Years
measure: Physician-reported clinical outcome (d)
timeFrame: 2 Years
measure: Physician-reported clinical outcome (e)
timeFrame: 2 Years
measure: Physician-reported clinical outcome (f)
timeFrame: 2 Years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Ames
country: United States
facility: McFarland Clinic P.C.
state: Iowa
city: Des Moines
country: United States
facility: Mission Cancer and Blood
state: Iowa
city: New Orleans
country: United States
facility: Tulane Cancer Center
state: Louisiana
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland PA
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center Michigan Medicine
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Hawthorne
country: United States
facility: Westchester Medical Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Durham
country: United States
facility: VA Medical Center - Durham
state: North Carolina
city: Greenville
country: United States
facility: Leo Jenkins Cancer Center/ECU School of Medicine
state: North Carolina
city: Canton
country: United States
facility: Mercy Medical Center
state: Ohio
city: Marion
country: United States
facility: Ohio Health Marion Area Physicians
state: Ohio
city: Massillon
country: United States
facility: Tri County Hematology & Oncology Associates, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Cancer Institute of Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: UW Medicine
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/North Star Lodge
state: Washington
city: Milwaukee
country: United States
facility: Froedtert & Medical College Clinics
state: Wisconsin
Study officials:
affiliation: Incyte Corporation
name: John P Galvin, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.