PENTALLO (PENTAglobin in Acute Leukemia and ALLOgeneic transplants)
Key facts
- Where
- Brescia, Cagliari, Naples, Rome és Turin, OlaszországSee the 6 sites
- Phase
- 2. fázis
Where in Olaszország
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, OlaszországNo longer taking part
- ARNAS G. BrotzuCagliari, OlaszországNo longer taking part
- Azienda Ospedaliera di Rilievo Nazionale Antonio CardarelliNaples, OlaszországNo longer taking part
- Azienda Ospedaliera Policlinico Universitario Tor VergataRome, OlaszországNo longer taking part
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, OlaszországNo longer taking part
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gruppo Italiano Per Il Trapianto Di Midollo Osseo Cellule Staminali Emopoietiche E Terapia Cellulare
- Trial code
- EU 2024-518940-19-02
- Record updated
- 2025. szeptember 17.
- Original description
To demonstrate that the early addition of Pentaglobin to the best available antimicrobial therapy is able to reduce mortality and improve survival in neutropenic febrile acute leukemia or allo- Hematopoietic stem cell transplantation (HSCT) patients colonized by carbapenem-resistant Enterobacteriaceae (CRE) or by any Pseudomonas aeruginosa (PA).Read full original descriptionShow less
Pentaglobin as early adjuvant treatment for febrile neutropenia in acute leukemia or allogeneic hematopoietic stem cell transplant patients colonized by carbapenem-resistant Enterobacteriaceae or Pseudomonas aeruginosa
To demonstrate that the early addition of Pentaglobin to the best available antimicrobial therapy is able to reduce mortality and improve survival in neutropenic febrile acute leukemia or allo- Hematopoietic stem cell transplantation (HSCT) patients colonized by carbapenem-resistant Enterobacteriaceae (CRE) or by any Pseudomonas aeruginosa (PA).
Inclusion: 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.
Exclusion: 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; Uncontrolled systemic infection; Hypersensitivity to the active substance or to any of the excipients of Pentaglobin; Patients who on the basis of the investigator's consideration are not able to give the informed consent; Pregnancy or lactation.