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Completed

NCT Number: NCT05750706

Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative

The study aims to evaluate incidence of invasive antifungal infections among patients with acute lymphoblastic leukemia Ph negative during the first weeks of treatment

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Key information

Conditions

Acute Lymphoblastic Leukemia, Adult Bacterial Infections and Mycoses Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Invasive Fungal Infections Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Mycoses Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of acute lymphoblastic leukemia Ph negative
  • age more than 18 yo

Exclusion criteria

  • diagnosis of acute lymphoblastic leukemia Ph positive
  • acute lymphoblastic leukemia relapsed/refractory
  • lymphoblastic lymphoma

Treatment and study plan

observation of invasive fungal infections

Other

observation of invasive fungal infections during chemotherapy

Primary outcomes

  1. Incidence of invasive fungal infections

    Time frame: 18 months

    Incidence of invasive fungal infections during first week of chemotherapy

Secondary outcomes

  1. Mortality rate

    Time frame: 30 months

    Mortality rate among patients with invasive fungal infections

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • A.O.U. Città della Salute e della Scienza
  • ASST Sette Laghi
  • Asst Degli Spedali Civili Di Brescia
  • Azienda Ospedaliera "Sant'Andrea"
  • Azienda Ospedaliera San Gerardo di Monza
  • Azienda Ospedaliera Universitaria Integrata Verona
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
  • Azienda Ospedaliero-Universitaria di Parma
  • Azienda Sanitaria Universitaria Friuli Centrale
  • Campus Bio-Medico University
  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  • Fondazione IRCCS Policlinico San Matteo di Pavia
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • IRCCS Casa Sollievo della Sofferenza
  • Istituto Oncologico Veneto IRCCS
  • Ospedale San Bortolo di Vicenza
  • S.Eugenio Hospital
  • San Gallicano Dermatological Institute IRCCS
  • San Giovanni Addolorata Hospital
  • San Raffaele University Hospital, Italy
  • University of Modena and Reggio Emilia
  • University of Rome Tor Vergata
  • Vito Fazzi Hospital

Registry information

Official study title

Prospective Observational Study on Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative

Acronym: SEIFEM

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2023
Registry last updated
May 6, 2026

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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