Penataglobin profilaxis in patients with acute leukemia or candidate to allogeneic transplant colonized by carbapenem-resistant Enterobacteriaceae or Pseudomonas aeruginosa

Phase 1

• Conditions: The study will enroll consecutive adult patients suffering from acute leukemia candidate to intensive chemotherapy or patients with hematological cancers candidate to allogeneic transplant with a documented colonization sustained by Carbapenem-resistant Enterobacteriaceae or Pseudomonas aeruginosa.; MedDRA version: 20.0Level: LLTClassification code 10013120Term: Diseases of blood and blood-forming organs, unspecifiedSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-001344-57-IT
• Lead Sponsor: GITMO GRUPPO ITALIANO PER IL TRAPIANTO DI MIDOLLO OSSEO, CELLULE STAMINALI EMOPOIETICHE E TERAPIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

•Age > or = 18 years
•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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified