Lenalidomide Monotherapy in R/R DLBCL

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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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)

Conditions
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Diffuse Large B Cell Lymphoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best overall/objective response rate (ORR) | Proportion of patients with complete response (CR) or partial response (PR) as best response achieved at any time during the study | Through study completion, an average of 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from treatment start until death from any cause | Through study completion, an average of 9 months | 
| Complete response rate | Proportion of patients having CR based on the best objective response achieved at any time during the study | Through study completion, an average of 9 months | 
| Disease control rate | Proportion of patients having CR, PR or stable disease (SD) based on the best objective response achieved at any time during the study | Through study completion, an average of 9 months |