NCT Number: NCT06782789
The study is pilot, observational, retrospective, Italian multicenter study.
Interested in participating?
Request Info18 year and older
All sexes
Observational
IRCCS Azienda Ospedaliero - Universitaria di Bologna, Bologna, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 2 years
Disease free survival (DFS) is defined as the time from randomization until evidence of disease recurrence
Time frame: through study completion, an average of 2 years
Best response rate (BRR)
Contact information is provided by the study sponsor or research team.
Beatrice Casadei, MD
CONTACT
Pier Luigi Zinzani, MD
CONTACT
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Acronym: TALOs
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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