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realMIND: Observational Study on Safety and Effectiveness of Tafasitamab in Combination With Lenalidomide in Patients With Relapsed or Refractory DLBCL
Trial Status: active
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.
Inclusion 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04981795.
Locations matching your search criteria
United States
California
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Status: Active
Name Not Available
Michigan
Ann Arbor
University of Michigan Rogel Cancer Center
Status: Active
Name Not Available
New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Name Not Available
North Carolina
Durham
Duke University Medical Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio