Not recruitingRare disease

Study on Pentaglobin for Treating Fever in Acute Leukemia or Stem Cell Transplant Patients with Resistant Bacteria

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients with acute leukemia or those who have undergone an allogeneic hematopoietic stem cell transplant. These patients are at risk of developing a condition called febrile neutropenia, which is a fever that occurs when the body has a low number of a type of white blood cell called neutrophils. This condition can be particularly dangerous if the patients are also colonized by certain bacteria, such as carbapenem-resistant Enterobacteriaceae or Pseudomonas aeruginosa, which are resistant to many antibiotics.

The study is testing a treatment called Pentaglobin, which is a solution containing different types of proteins called immunoglobulins. These proteins are part of the immune system and help the body fight infections. The purpose of the study is to see if adding Pentaglobin early in the treatment can reduce the risk of death and improve survival rates in these patients. The study will compare the effects of Pentaglobin with the best available antimicrobial therapy, which is the standard treatment for infections.

Participants in the study will receive Pentaglobin through an infusion, which means it will be given directly into the bloodstream. The treatment will be administered for a maximum of three days. The study will monitor the patients for several months to see how well they respond to the treatment and to check for any side effects. The goal is to find out if Pentaglobin can help improve the outcomes for patients with febrile neutropenia who are at high risk due to these resistant bacteria.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis, and pre-treatment conditions.
Informed consent is required, and participants must agree to use appropriate contraceptive methods if applicable.
Step 2
Initial treatment phase
Treatment begins with the administration of Pentaglobin, a solution for infusion containing immunoglobulins A, G, and M.
The infusion is started within 12 hours after the development of fever.
Step 3
Monitoring and follow-up
Participants are monitored for 30 days to assess the reduction in fever and the need for hospitalization.
The study evaluates the incidence and severity of any adverse reactions to the treatment.
Step 4
Extended observation
The study continues to observe participants for up to 4 months to assess overall survival and any non-relapse mortality.
Additional monitoring includes the incidence of graft failure and recovery of blood cell counts.
Step 5
Long-term outcomes
Participants are observed for up to one year to evaluate the incidence of chronic conditions and overall survival without relapse.

Who can join the trial?

10 criteria

You must be **18 years or older**.
If you are a man with a partner who can become pregnant, you must agree to use a **barrier contraceptive method** during the trial. This means using something like a condom to prevent pregnancy.
Your **performance status** must be **ECOG less than 3**. This is a way to measure how well you can perform daily activities. A lower number means you are more active.
You must have a diagnosis of **acute myeloid leukemia** or **acute lymphoblastic leukemia** and be a candidate for **intensive chemotherapy** or **allogeneic hematopoietic stem cell transplantation (HSCT)**. This includes certain blood cancers and severe aplastic anemia. A second transplant is allowed.
You must have a **pre-treatment colonization** by **Carbapenem-resistant Enterobacteriaceae (CRE)** or **Pseudomonas aeruginosa (PA)**. This means these bacteria are present in your body, confirmed by a swab from your rectum or throat, or a blood infection.
You must provide **written and signed informed consent**. This means you agree to participate after understanding the study details.
If you are participating in other clinical studies for **allogeneic HSCT**, you can still join this study if those studies use an approved investigational compound.
You must be able to start treatment with **Pentaglobin** within **12 hours** after developing a fever.
You should not receive treatment with other **immunoglobulins** (like IVIG or Cytotect) during the time you are treated with Pentaglobin.
If you are a woman who can become pregnant, you must have a **negative pregnancy test** at the start of the study and agree to use **two different methods of contraception** during the trial.

Who cannot join the trial?

6 criteria

Patients who are not diagnosed with Acute Myeloid Leukemia (AML). AML is a type of cancer that affects the blood and bone marrow.
Patients who are not experiencing neutropenic fever. Neutropenic fever is a condition where a person has a fever and a low number of neutrophils, which are a type of white blood cell important for fighting infections.
Patients who have not undergone allo-Hematopoietic stem cell transplantation (HSCT). This is a procedure where a patient receives blood-forming stem cells from a donor.
Patients who are not colonized by carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas aeruginosa (PA). These are types of bacteria that are resistant to many antibiotics and can cause infections.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, as they are not selected for this study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Verified
Turin, Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli
Verified
Naples, Italy
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

Trial locations

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Investigated drugs

Pentaglobin is a medication used in this trial as an early additional treatment for patients with febrile neutropenia, a condition characterized by fever and low levels of neutrophils, a type of white blood cell. It is being tested to see if it can help reduce mortality and improve survival rates in patients with acute leukemia or those who have undergone an allogeneic hematopoietic stem cell transplant. These patients are also colonized by bacteria that are resistant to certain antibiotics, specifically carbapenem-resistant Enterobacteriaceae or Pseudomonas aeruginosa. Pentaglobin is added to the best available antimicrobial therapy to see if it provides additional benefits.

What is already known about the treatment

Pentaglobin – Pentaglobin is administered intravenously, typically as an infusion. It is currently being studied in clinical trials for its potential benefits in treating febrile neutropenia in patients with acute leukemia or those who have undergone allogeneic hematopoietic stem cell transplantation. The main therapeutic indication is to reduce mortality and improve survival in these patients, especially those colonized by carbapenem-resistant bacteria. At the molecular level, Pentaglobin works by providing a broad spectrum of antibodies that enhance the immune response against infections. It is classified as an immunoglobulin preparation, which is used to support the immune system in fighting infections.

Investigated diseases

Acute Myeloid Leukemia (AML) – Acute Myeloid Leukemia is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. These abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. As the disease progresses, it can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. AML can develop quickly and requires prompt medical attention. It is more common in adults and can vary in its specific genetic mutations and characteristics. The progression of the disease can be aggressive, necessitating intensive treatment strategies.