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This observational study is designed to characterise the effectiveness of lenalidomide monotherapy in the treatment of R/R DLBCL and to compare the results with the efficacy outcomes of a tafasitamab-lenalidomide combination therapy in the clinical trial MOR208C203 (L-MIND)
Condition or disease
Diffuse Large B Cell Lymphoma
Tafasitamab (MOR00208) is currently in development for the treatment of R/R DLBCL. An ongoing, single-arm, phase II, open label, multicenter study (MOR208C203) is evaluating the efficacy and safety of tafasitamab combined with lenalidomide in patients with R/R DLBCL. In order to establish a lenalidomide monotherapy as a control cohort, this observational study aims to collect retrospective lenalidomide monotherapy data from real-world-evidence and to compare it with the tafasitamab-lenalidomide combination therapy.
An Observational Retrospective Cohort Study of Lenalidomide Monotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) to Generate a Historical Control for Clinical Trial MOR208C203 (RE-MIND)
Actual Study Start Date :
June 2, 2019
Actual Primary Completion Date :
August 29, 2019
Estimated Study Completion Date :
March 31, 2020
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
R/R DLBCL patients not eligible for HDC followed by ASCT who were treated with lenalidomide monotherapy
Histologically confirmed diagnosis of DLBCL
Relapsed/refractory to at least one previous systemic therapy for DLBCL
Received at least one, but no more than three previous systemic regimens for the treatment of DLBCL, including at least one anti-CD20 containing therapy
Received lenalidomide monotherapy for R/R DLBCL while being considered not eligible for an ASCT
CNS involvement by lymphoma
Patients who received lenalidomide in combination with another anti-lymphoma therapy (including radiation)
Previously treated with anti-CD19-targeted therapy or immunomodulatory drugs
Patients who previously underwent allogeneic SCT
Known simultaneous detection of MYC and BCL2 or BCL6 translocation according to FISH
Patients with a history of other malignancies within 5 years prior to lenalidomide treatment start