Lenalidomide Monotherapy in R/R DLBCL (RE-MIND)

MorphoSys

Status: Completed

Conditions: Diffuse Large B Cell Lymphoma

Study type: Observational

Funder types: Industry

Identifiers

NCT04150328

MOR208C206

Details and patient eligibility

About

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)

Full 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.

Enrollment: 490 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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