Lenalidomide Monotherapy in R/R DLBCL

MorphoSys AG490 enrolled

Overview

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)

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.

Study Type

OBSERVATIONAL

Enrollment

490

Conditions

Diffuse Large B Cell Lymphoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (57)

Outcomes

Primary Outcomes

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

Time frame: Through study completion, an average of 9 months

Secondary Outcomes

Overall survival

Time from treatment start until death from any cause

Time frame: 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

Time frame: 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

Time frame: Through study completion, an average of 9 months

Data from ClinicalTrials.gov

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MorphoSys Research Site

Rochester, Minnesota, United States

MorphoSys Research Site

St Louis, Missouri, United States

MorphoSys Research Site

Manhasset, New York, United States

MorphoSys Research Site

New York, New York, United States

MorphoSys Research Site

Rochester, New York, United States

MorphoSys Research Site

Dublin, Ohio, United States

MorphoSys Research Site

Charleston, South Carolina, United States

MorphoSys Research Site

Greenville, South Carolina, United States

MorphoSys Research Site

Bordeaux, France

MorphoSys Research Site

Le Mans, France

...and 47 more locations