Impact of Pre-existing Invasive Aspergillosis on Allogeneic Stem Cell Transplantation (IPAT)
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|ClinicalTrials.gov Identifier: NCT03014934|
Recruitment Status : Unknown
Verified January 2017 by European Group for Blood and Marrow Transplantation.
Recruitment status was: Recruiting
First Posted : January 9, 2017
Last Update Posted : January 20, 2017
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|
|Study Type :||Observational|
|Estimated Enrollment :||2100 participants|
|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|
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
- Non-relapse mortality [ Time Frame: 1 year ]One year non-relapse mortality cumulative incidence
- Relapse free survival [ Time Frame: 1 year ]One year relapse free survival
- Overall survival [ Time Frame: 1 year ]One year overall survival
- Incidence and severity of Graft versus Host Disease [ Time Frame: 1 year ]One year incidence and severity of Graft versus Host Disease
- Incidence of relapse [ Time Frame: 1 year ]One year incidence of relapse
- Status of Invasive Aspergillosis [ Time Frame: 1 year ]Status of Invasive Aspergillosis, before conditioning and at 1 year
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
|Contact: Jennifer Hoek, MDfirstname.lastname@example.org|
|Charité Universitätsmedizin Berlin||Recruiting|
|Berlin, Germany, 13353|
|Contact: Renate Arnold 49-30-450-553-302 email@example.com|
|Institute G. Gaslini||Recruiting|
|Genova, Italy, 16148|
|Contact: Edoardo Lanino, MD 39-010-5636-2405 firstname.lastname@example.org|
|Clinica di Oncoematologia Pediatrica||Recruiting|
|Padova, Italy, 35128|
|Contact: Giuseppe Basso 39-049-821-3579 email@example.com|
|Ospedale Infantile Regina Margherita||Recruiting|
|Torino, Italy, 10126|
|Contact: Franca Fagioli, MD +39-011-313-5360 firstname.lastname@example.org|
|King Faisal Specialist Hospital & Research Centre||Recruiting|
|Riyadh, Saudi Arabia, 11211|
|Contact: Mahmoud Aljurf (996-1) 442-4586 email@example.com|
|Hospital Santa Creu i Sant Pau||Recruiting|
|Barcelona, Spain, 08041|
|Contact: Jorge Sierra, MD 34-93-556-5649 firstname.lastname@example.org|
|Basel, Switzerland, 4031|
|Contact: Helen Baldomero +41 61 265 3203 Helen.Baldomero@usb.ch|
|Gazi University School of Medicine||Recruiting|
|Ankara, Turkey, 06500|
|Contact: Ulker Kocak, MD +90 0312-202-60-15 email@example.com|
|Principal Investigator:||Olaf Penack, MD||Charite University, Berlin, Germany|
|Study Chair:||Jan Styczynski||University Hospital, Collegium Medicum UMK|