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An Italian Multicentric Retrospective Observational Study to Assess Effectiveness and Safety of the Combination of Tafasitamab and Lenalidomide in Diffuse Large B-cell Lymphoma Patients Treated Under Named Patient Program (TALOs)

S

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Enrolling

Conditions

Diffuse Large B Cell Lymphoma (DLBCL)

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

The study is pilot, observational, retrospective, Italian multicenter study.

Full 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.

Enrollment

96 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

11

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Central trial contact

Pier Luigi Zinzani, MD; Beatrice Casadei, MD

Data sourced from clinicaltrials.gov

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