Clinical Trial: Impact of Pre-existing Invasive Aspergillosis on Allogeneic Stem Cell Transplantation
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Impact of Pre-existing Invasive Aspergillosis on Allogeneic Hematopoietic Stem Cell Transplantation for Treatment of Acute Leukaemia and Myelodysplastic Syndrome
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.
Detailed Summary:
Background & Rationale. In patients with pre-existing invasive aspergillosis allo-HSCT is feasible without progression of fungal infection. However, the influence of invasive pulmonary aspergillosis (IA) on transplant related complications and on long term survival has not been investigated in a larger patient cohort under current conditions.
Recently the IDWP and ALWP performed a retrospective analysis on the impact of preexisting aspergillosis on allo-HSCT outcome.2 In summary, there was a trend towards impaired outcome of allo-HSCT in patients with prior IA but there was no significant impact on important allo-HSCT transplant outcomes, such as survival, GVHD and relapse. The data suggest that a history of IA should not generally be considered a contraindication for allo-HSCT. To be able to more precisely investigate the impact of IA on allo-HSCT, a non-interventional prospective study is needed.
Primary objective:
To determine if pre-existing IA influences non-relapse mortality after allo-HSCT
Secondary objectives:
- To determine if pre-existing IA influences:
- relapse free survival
- overall survival
- incidence and severity of GVHD
- incidence of relapse
- incidence of IA post allo-HSCT
for the subgroup of transplant with previous IA
• progression of IA
Research design:
One year non-relapse mortality cumulative incidence
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: European Group for Blood and Marrow Transplantation
Dates:
Date Received: January 6, 2017
Date Started: January 2016
Date Completion: December 2018
Last Updated: January 19, 2017
Last Verified: January 2017