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

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ClinicalTrials.gov Identifier: NCT03014934
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
European Group for Blood and Marrow Transplantation

Brief 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.


Condition or disease
Invasive Aspergillosis

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 2100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Pre-existing Invasive Aspergillosis on Allogeneic Hematopoietic Stem Cell Transplantation for Treatment of Acute Leukaemia and Myelodysplastic Syndrome
Study Start Date : January 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis
U.S. FDA Resources

Group/Cohort
Cases: Prior Invasive Aspergillosis
History of probable or proven Invasive Aspergillosis according to EORTC 2008 criteria
Controls: No prior proven Invasive Aspergillosis
Patients really negative for Invasive Aspergillosis and those with possible Invasive Aspergillosis



Primary Outcome Measures :
  1. Non-relapse mortality [ Time Frame: 1 year ]
    One year non-relapse mortality cumulative incidence


Secondary Outcome Measures :
  1. Relapse free survival [ Time Frame: 1 year ]
    One year relapse free survival

  2. Overall survival [ Time Frame: 1 year ]
    One year overall survival

  3. Incidence and severity of Graft versus Host Disease [ Time Frame: 1 year ]
    One year incidence and severity of Graft versus Host Disease

  4. Incidence of relapse [ Time Frame: 1 year ]
    One year incidence of relapse

  5. Status of Invasive Aspergillosis [ Time Frame: 1 year ]
    Status of Invasive Aspergillosis, before conditioning and at 1 year



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
First allo-HSCT in patients with acute leukaemia and MDS given stem cell grafts.
Criteria

Inclusion Criteria:

  • First allo-HSCT
  • Acute leukaemia or MDS
  • Received stem cell grafts

Exclusion Criteria:

  • History, in the 6 months preceding HSCT, or documented presence of Invasive candida or mould infections other than IA (Mucor, Fusariosis).
  • (Previous history Candida infection, both superficial or systemic, is not an exclusion criteria if the patient has completely recovered from it at HSCT).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014934


Contacts
Contact: Jennifer Hoek, MD +31715265668 j.d.c.hoek@lumc.nl

Locations
Germany
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13353
Contact: Renate Arnold    49-30-450-553-302    renate.arnold@charite.de   
Italy
Institute G. Gaslini Recruiting
Genova, Italy, 16148
Contact: Edoardo Lanino, MD    39-010-5636-2405    edoardolanino@gaslini.org   
Clinica di Oncoematologia Pediatrica Recruiting
Padova, Italy, 35128
Contact: Giuseppe Basso    39-049-821-3579    giuseppe.basso@unipd.it   
Ospedale Infantile Regina Margherita Recruiting
Torino, Italy, 10126
Contact: Franca Fagioli, MD    +39-011-313-5360    franca.fagioli@unito.it   
Saudi Arabia
King Faisal Specialist Hospital & Research Centre Recruiting
Riyadh, Saudi Arabia, 11211
Contact: Mahmoud Aljurf    (996-1) 442-4586    maljurf@kfshrc.edu.sa   
Spain
Hospital Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08041
Contact: Jorge Sierra, MD    34-93-556-5649    tolius@santpau.cat   
Switzerland
University Hospital Recruiting
Basel, Switzerland, 4031
Contact: Helen Baldomero    +41 61 265 3203    Helen.Baldomero@usb.ch   
Turkey
Gazi University School of Medicine Recruiting
Ankara, Turkey, 06500
Contact: Ulker Kocak, MD    +90 0312-202-60-15    ulkerkocak@gazi.edu.tr   
Sponsors and Collaborators
European Group for Blood and Marrow Transplantation
Investigators
Principal Investigator: Olaf Penack, MD Charite University, Berlin, Germany
Study Chair: Jan Styczynski University Hospital, Collegium Medicum UMK

Responsible Party: European Group for Blood and Marrow Transplantation
ClinicalTrials.gov Identifier: NCT03014934     History of Changes
Other Study ID Numbers: EBMT-8414113
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by European Group for Blood and Marrow Transplantation:
Aspergillosis
IA

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases