Lenalidomide Monotherapy in R/R DLBCL

Completed

• Conditions: Diffuse Large B Cell Lymphoma

• Registration Number: NCT04150328
• Lead Sponsor: MorphoSys AG

Brief Summary

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

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 Timeline

• Study Start: 2019-04-12
• Primary Completion: 2019-08-25
• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-01
• Study First Posted: 2019-11-04
• Study Completion: 2020-08-25
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

MorphoSys Research Site; 🇪🇸 Salamanca, Spain

MorphoSys Research State; 🇮🇹 Novara, Italy