Acute Myeloid Leukemia (AML)
Conditions
Brief summary
This study will have two co-primary endpoints: • To demonstrate a 50% reduction in 30-day mortality for carriers developing a pre-engraftment bloodstream infection sustained by carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas aeruginosa (PA) (earlier primary endpoint). To increase by 20% the Overall Survival (OS) at 4 months from the start of intensive treatment in all carriers of CRE or PA compared to historical controls (later primary endpoint).
Detailed description
OS in CRE or PA carriers not developing a bloodstream infection sustained the colonizing agent at 4 months from the start of intensive chemotherapy or transplant; Days of fever > 38.3°C at 30 days from the day of start intensive chemotherapy or from day of transplant. Days of hospitalization at 30 days from the start of intensive chemotherapy or from day of transplant; Days of i.v. antimicrobials at 30 days from the start of intensive chemotherapy or from day of transplant., Non-relapse mortality (NRM) at 4 months from the start of intensive chemotherapy or transplant; Incidence and severity of adverse drug reactions (ADR) classified by System Organ Class (SOC) and preferred term (PT) at 30 days from start treatment with Pentaglobin; Incidence and severity of acute GvHD at 120 days from day of transplant. Incidence and severity of chronic GvHD at 1 year day of transplant., The cumulative incidence of graft failure / time to neutrophil and platelet recovery at 30 and 60 days from the day of start intensive chemotherapy or from day of transplant. One year probability of GRFS (GvHD free, relapse free survival) from the day of start intensive chemotherapy or from day of transplant.
Interventions
Sponsors
Gruppo Italiano Per Il Trapianto Di Midollo Osseo Cellule Staminali Emopoietiche E Terapia Cellulare
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study will have two co-primary endpoints: • To demonstrate a 50% reduction in 30-day mortality for carriers developing a pre-engraftment bloodstream infection sustained by carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas aeruginosa (PA) (earlier primary endpoint). To increase by 20% the Overall Survival (OS) at 4 months from the start of intensive treatment in all carriers of CRE or PA compared to historical controls (later primary endpoint). | — |
Secondary
| Measure | Time frame |
|---|---|
| OS in CRE or PA carriers not developing a bloodstream infection sustained the colonizing agent at 4 months from the start of intensive chemotherapy or transplant; Days of fever > 38.3°C at 30 days from the day of start intensive chemotherapy or from day of transplant. Days of hospitalization at 30 days from the start of intensive chemotherapy or from day of transplant; Days of i.v. antimicrobials at 30 days from the start of intensive chemotherapy or from day of transplant., Non-relapse mortality (NRM) at 4 months from the start of intensive chemotherapy or transplant; Incidence and severity of adverse drug reactions (ADR) classified by System Organ Class (SOC) and preferred term (PT) at 30 days from start treatment with Pentaglobin; Incidence and severity of acute GvHD at 120 days from day of transplant. Incidence and severity of chronic GvHD at 1 year day of transplant., The cumulative incidence of graft failure / time to neutrophil and platelet recovery at 30 and 60 days from the da | — |
Countries
Italy
Outcome results
None listed