Diffuse Large B Cell Lymphoma (DLBCL)
Conditions
Keywords
tafasitamab, lenalidomide
Brief summary
The study is pilot, observational, retrospective, Italian multicenter study.
Detailed description
The study will involve the collection of patient data from medical records of patients with R/R DLBCL treated with at least one dose of tafasitamab in association with lenalidomide as part of standard of care under the NPP (D.M. 7 Sep 2017), between April 2022 and December 2022, in several selected Italian centres. The observational, non-interventional nature of the study is based on the retrospective observation of current clinical practice without the application of any kind of ad hoc 'intervention' for the study itself. In fact, patients participating in the study will not be subjected to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for the study are those that are already commonly collected by the physicians in clinical practice.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed diagnosis of R/R DLBCL. 2. Patientswho received at least one dose of tafasitamab in association with lenalidomide under the NPP (D.M. 7 Sep 2017), between April 2022 and December 2022. 3. Age ≥ 18 years at enrollment. 4. Signature of written informed consent (if applicable).
Exclusion criteria
1\) R/R DLBCL patients who received tafasitamab in association with lenalidomide in a clinical trial context.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate (ORR) | through study completion, an average of 2 years | ORR as the sum of complete response \[CR\] and partial response \[PR\] rate. The study aims to retrospectively evaluate the effectiveness of tafasitamab in association with lenalidomide in patients with R/R DLBCL treated with at least one dose of tafasitamab in association with lenalidomide under the NPP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity of study drug | from enrollment untill 30 days from last infusion | Type, incidence, severity of any adverse events (AE) occurred from start of treatment to 30 days after last infusion and their possible relationship with study drugs |
| Progression Free Survival (PFS) | through study completion, an average of 2 years | The length of time during and after the treatment that patients live with the disease, but it does not get worse. Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause. |
| Duration of Response (DoR) | through study completion, an average of 2 years | the secondary aim is to evaluate effectiveness of tafasitamab in association with lenalidomide under the NPP (D.M. 7 Sep 2017) |
| Duration Free Survival (DFS) | through study completion, an average of 2 years | Disease free survival (DFS) is defined as the time from randomization until evidence of disease recurrence |
| Best response rate (BRR) | through study completion, an average of 2 years | Best response rate (BRR) |
| Overall Survival (OS) | through study completion, an average of 2 years | Overall Survival, the percentage of patients alive, is defined from the start date of therapy to the date of death from any cause. |
Countries
Italy
Contacts
Primary ContactPier Luigi Zinzani, MD
Backup ContactBeatrice Casadei, MD
Outcome results
None listed