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