Diffuse Large B Cell Lymphoma
Conditions
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.
Interventions
None listed
Sponsors
MorphoSys AG
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Through study completion, an average of 9 months | Time from treatment start until death from any cause |
| 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 |
| 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 |
Countries
France, Italy, Spain, United States
Outcome results
None listed