Immunoglobulin A; Immunoglobulin G; Immunoglobulin M for Acute Myeloid Leukemia | Acute Lymphoblastic Leukemia | Severe aplastic anemia | Recipients of allogeneic hematopoietic stem cell transplantation

Inclusion criteria

• {"criterion_text":"- Age > or = 18 years"}
• {"criterion_text":"- Men enrolled in the study with partners who are women of child bearing potential, must be willing to use an acceptable barrier contraceptive method during the trial."}
• {"criterion_text":"- Performance status: ECOG <3"}
• {"criterion_text":"- Diagnosis of acute myeloid leukemia or acute lymphoblastic leukemia candidate to intensive chemotherapy or Indication to allogeneic Hematopoietic stem cell transplantation (HSCT) for hematological cancers, including severe aplastic anemia (second transplants allowed)"}
• {"criterion_text":"- Pre-treatment colonization by Carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas aeruginosa (PA) documented by rectal and/or pharyngeal swab or pre-treatment bloodstream infection sustained by CRE or PA"}
• {"criterion_text":"- Written and signed informed consent"}
• {"criterion_text":"- Patients participating in other clinical studies for allogeneic HSCT are also eligible to this study if the above-mentioned trials are using an approved investigational compound"}
• {"criterion_text":"- Possibility of starting treatment with Pentaglobin <12 hours after development of fever"}
• {"criterion_text":"- Treatment with other immunoglobulins (e.g. IVIG, Cytotect) should be not administered during the time of treatment with Pentaglobin."}
• {"criterion_text":"- Women of child-bearing potential enrolled in the study must have a negative pregnancy test at screening and agree to use two distinct acceptable methods of contraception during the trial."}

Exclusion criteria

• {"criterion_text":"- Uncontrolled systemic infection"}
• {"criterion_text":"- Hypersensitivity to the active substance or to any of the excipients of Pentaglobin"}
• {"criterion_text":"- Patients with previous anaphylaxis or severe reactions to immunoglobulins preparation"}
• {"criterion_text":"- Severe concomitant illness: o\tpatients with severe renal impairment o\tpatients with severe pulmonary impairment o\tpatients with severe cardiac impairment o\tpatients with severe hepatic impairment"}
• {"criterion_text":"- Patients who on the basis of the investigator's consideration are not able to give the informed consent."}
• {"criterion_text":"- Pregnancy or lactation."}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"30-day mortality measured for carriers who develop a pre-engraftment bloodstream infection due to CRE or PA; comparison target is a 50% reduction (as stated)."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Overall Survival at 4 months from start of intensive chemotherapy or transplant compared to historical controls; target increase of 20%."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Overall Survival at 4 months measured in carriers who do not develop bloodstream infection by the colonizing agent."}
• {"endpoint_text":"- Days of fever > 38.3°C at 30 days from the day of start intensive chemotherapy or from day of transplant.","definition_or_measurement_approach":"Number of days with temperature >38.3°C within 30 days from start of intensive chemotherapy or transplant."}
• {"endpoint_text":"- Days of hospitalization at 30 days from the start of intensive chemotherapy or from day of transplant","definition_or_measurement_approach":"Total days hospitalized within 30 days from start of intensive chemotherapy or transplant."}
• {"endpoint_text":"- Days of i.v. antimicrobials at 30 days from the start of intensive chemotherapy or from day of transplant.","definition_or_measurement_approach":"Number of days on intravenous antimicrobial therapy within 30 days from start of intensive chemotherapy or transplant."}
• {"endpoint_text":"- Non-relapse mortality (NRM) at 4 months from the start of intensive chemotherapy or transplant","definition_or_measurement_approach":"Non-relapse mortality measured at 4 months from start of intensive chemotherapy or transplant."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Incidence and severity of ADRs up to 30 days after start of Pentaglobin, classified by SOC and PT."}
• {"endpoint_text":"- Incidence and severity of acute GvHD at 120 days from day of transplant.","definition_or_measurement_approach":"Incidence and severity of acute graft-versus-host disease assessed at 120 days post-transplant."}
• {"endpoint_text":"- Incidence and severity of chronic GvHD at 1 year day of transplant.","definition_or_measurement_approach":"Incidence and severity of chronic graft-versus-host disease assessed at 1 year after transplant."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Cumulative incidence of graft failure and time to neutrophil and platelet recovery assessed at 30 and 60 days from start of intensive chemotherapy or transplant."}
• {"endpoint_text":"- One year probability of GRFS (GvHD free, relapse free survival) from the day of start intensive chemotherapy or from day of transplant.","definition_or_measurement_approach":"Probability of graft-versus-host disease free, relapse free survival at 1 year from start of intensive chemotherapy or transplant."}

Italy

Earliest CTIS Part Ii Submission Date

02-12-2024

Latest Decision Or Authorization Date

17-09-2025

Processing Time Days

289

Number Of Sites

6

Number Of Participants

120

Primary sponsor

Full Name

Gruppo Italiano Per Il Trapianto Di Midollo Osseo Cellule Staminali Emopoietiche E Terapia Cellulare

Organisation Type

Patient organisation/association

Country Of Registered Address

Italy