Seifem

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Studies Completed

Multicentric retrospective study of infectious complications in patients with lymphoproliferative diseases treated with target therapy – SEIFEM STUDY 2017

  • Gianpaolo Nadali
  • SPONSOR: Azienda Ospedaliera Universitaria Integrata Verona – Ematologia
  • 14 Mar, 2018

Introduction

In the last 5 years new compounds became available to treat haematological diseases. In particular, in the setting of lymphoproliferative disorders, different “target drugs” were introduced in clinical practice, namely new monoclonal antibodies (Obinutuzumab, Ofatumumab, Brentuximab), BTK inhibitor (Ibrutinib) and PI3K inhibitor (Idelalisib).

Efficacy and safety of these drugs were assessed in registrative clinical trials and data regarding long term infectious complications of the treated cohorts are currently unavailable.

Recently a number of case reports were published, mainly regarding fungal infections, in patients treated by BTK and PI3K inhibitors.

This observational retrospective clinical-epidemiological study aims to collect data from 30 italian haematology centres were patients with lymphoproliferative diseases are treated with above listed drugs for registered indications, since their commercial availability.

Aims of the study

Primary

  • Incidence of infectious complications (viral, bacterial, fungal) in patients with lymphoproliferative diseases  treated with Obinutuzumab, Ofatumumab, Brentuximab, Ibrutinib e Idelalisib

 Secondary

  • Rate of patients receiving antiviral, antifungal, antibacterial prophylaxis
  • Rate of discontinuation of the target drug becaouse of infection
  • Outcome of the infection
  • Risk factors in the trated cohort

Inclusion criteria

Patients  ≥18 yrs of age, affected by lymphoproliferative diseases (Chronic Lymphocytic leukemia CLL, Non Hodgkin’s Lymphoma NHL, Hodgkin’s Lymphoma HL) 

  • Patients treated until 31/12/2016, with the following drugs, single therapy or in combination, from date of their comercial availability in Italy:
  • Obinutuzumab (from: 23/01/2015)
  • Ofatumumab (from: 04/07/2011)
  • Brentuximab (from: 21/07/2014)
  • Ibrutinib (from: 05/01/2016)
  • Idelalisib (from: 23/03/2015)

Exclusion criteria

  • Patients enrolled in clinical trials or in NPP.
  • Patients with active infections at the time of starting therapy.

Patients with other active neoplastic diseases.

Completed Studies