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Impact of Pre-existing Invasive Aspergillosis on Allogeneic Stem Cell Transplantation

NCT03014934 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2100

Last updated 2021-01-14

No results posted yet for this study

Summary

Via a prospective non-interventional study clinical outcome of patients with - and without - history of pre-existing invasive aspergillosis undergoing allo-HSCT will be assessed, in terms of non-relapse mortality overall mortality and fungal infectious morbidity.

Aim. Assessment of 1-year outcome of patients undergoing allo-HSCT with history of pre-existing IA vs. no pre-existing IA.

Hypothesis. NRM in patients with pre-existing IA is not higher (by a specified margin of 10%) than patients without pre-existing IA.

Study population. First allo-HSCT in patients with acute leukaemia and MDS given stem cell grafts.

Cohort 1: History of probable or proven invasive aspergillosis Cohort 2: No History of probable or proven invasive aspergillosis: this cohort includes also the patient with a history of possible mycosis not documented microbiologically.

Conditions

  • Invasive Aspergillosis

Sponsors & Collaborators

  • European Society for Blood and Marrow Transplantation

    lead NETWORK

Principal Investigators

  • Olaf Penack, MD · Charite University, Berlin, Germany

  • Jan Styczynski · University Hospital, Collegium Medicum UMK

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2021-09-30
Completion
2021-12-31

Countries

  • Germany
  • Italy
  • Saudi Arabia
  • Spain
  • Switzerland
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03014934 on ClinicalTrials.gov