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PENTALLO (PENTAglobin in Acute Leukemia and ALLOgeneic transplants)
EU CTIS ID: 2024-518940-19-02
What this study is testing
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).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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: o patients with severe renal impairment o patients with severe pulmonary impairment o patients with severe cardiac impairment o patients with severe hepatic impairment
- Patients who on the basis of the investigator's consideration are not able to give the informed consent.
- Pregnancy or lactation.
See the full eligibility criteria
- 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.
- 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: o patients with severe renal impairment o patients with severe pulmonary impairment o patients with severe cardiac impairment o patients with severe hepatic impairment
- Patients who on the basis of the investigator's consideration are not able to give the informed consent.
- Pregnancy or lactation.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.