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

Diffuse Large B-cell Lymphoma Clinical Trial

— realMIND  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981795
• Other study ID #: MOR208C414
• Status: Recruiting
• Start date: September 20, 2021
• Est. completion date: August 31, 2026

Study information

• Verified date: March 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Tafasitamab
Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide inPatients With Relapsed or Refractory DLBCL.

Locations

Country	Name	City	State
United States	McFarland Clinic P.C.	Ames	Iowa
United States	University of Michigan Comprehensive Cancer Center Michigan Medicine	Ann Arbor	Michigan
United States	American Oncology Partners of Maryland PA	Bethesda	Maryland
United States	Alabama Oncology	Birmingham	Alabama
United States	Mercy Medical Center	Canton	Ohio
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Mission Cancer and Blood	Des Moines	Iowa
United States	Henry Ford Health System	Detroit	Michigan
United States	VA Medical Center - Durham	Durham	North Carolina
United States	Leo Jenkins Cancer Center/ECU School of Medicine	Greenville	North Carolina
United States	Westchester Medical Center	Hawthorne	New York
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Clearview Cancer Institute	Huntsville	Alabama
United States	Ohio Health Marion Area Physicians	Marion	Ohio
United States	Tri County Hematology & Oncology Associates, Inc	Massillon	Ohio
United States	Froedtert & Medical College Clinics	Milwaukee	Wisconsin
United States	Morristown Medical Center	Morristown	New Jersey
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Tulane Cancer Center	New Orleans	Louisiana
United States	Integris Cancer Institute of Oklahoma	Oklahoma City	Oklahoma
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	UW Medicine	Seattle	Washington
United States	Lankenau Medical Center	Wynnewood	Pennsylvania
United States	Yakima Valley Memorial Hospital/North Star Lodge	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Patterns - Safety	Incidence and severity of Treatment-emergent serious AEs (SAEs) and AEs (TEAs)	2 Years
Primary	Treatment Patterns - Effectiveness (a)	Objective response rate (ORR)	2 Years
Primary	Treatment Patterns - Effectiveness (b)	Complete response (CR) rate	2 Years
Primary	Treatment Patterns - Effectiveness (c)	Duration of response (DoR)	2 Years
Primary	Treatment Patterns - Effectiveness (d)	OS	2 Years
Primary	Treatment Patterns - Effectiveness (e)	Progression-free survival (PFS)	2 Years
Primary	Treatment Patterns - Effectiveness (f)	Event-free survival (EFS)	2 Years
Secondary	Physician-reported clinical outcome (a)	Number of treatment lines prior to receiving tafasitamab	2 Years
Secondary	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
Secondary	Physician-reported clinical outcome (c)	Duration of combination treatment (i.e., duration of treatment with both tafasitamab and lenalidomide)	2 Years
Secondary	Physician-reported clinical outcome (d)	Modifications of dose and treatment schedule of tafasitamab and/or lenalidomide	2 Years
Secondary	Physician-reported clinical outcome (e)	Incidence of tafasitamab use with combination partners other than lenalidomide	2 Years
Secondary	Physician-reported clinical outcome (f)	Incidence of tafasitamab use as monotherapy (i.e., without any combination partners)	2 Years