PENTALLO (PENTAglobin in Acute Leukemia and ALLOgeneic transplants)

Prior treatment

• Patients with previous anaphylaxis or severe reactions to immunoglobulins preparation
• Severe concomitant illness: o patients with severe renal impairment o patients with severe pulmonary impairment o patients with severe cardiac impairment o patients with severe hepatic impairment

Other illness

• Uncontrolled systemic infection
• Hypersensitivity to the active substance or to any of the excipients of Pentaglobin

Other

• Patients who on the basis of the investigator's consideration are not able to give the informed consent.
• Pregnancy or lactation.

• Age > or = 18 years
• 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.
• Performance status: ECOG <3
• 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)
• 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
• Written and signed informed consent
• 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
• Possibility of starting treatment with Pentaglobin <12 hours after development of fever
• Treatment with other immunoglobulins (e.g. IVIG, Cytotect) should be not administered during the time of treatment with Pentaglobin.
• 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.