Ongoing Clinical Trials for Autologous Haematopoietic Stem Cell Transplant
Currently, there is 1 ongoing clinical trial related to autologous haematopoietic stem cell transplant. This trial focuses on preventing infections in patients with acute leukemia who are undergoing intensive chemotherapy or stem cell transplantation, comparing two different antibiotics to reduce the risk of fever and infection during treatment.
Clinical trial locations
Study Comparing Fosfomycin and Ciprofloxacin for Preventing Fever in Patients with Acute Leukemia After Chemotherapy or Stem Cell Transplant
This clinical trial is being conducted in Spain and focuses on preventing a serious complication called febrile neutropenia in patients with acute leukemia. Febrile neutropenia occurs when a person develops a fever while having very low levels of neutrophils, which are white blood cells that help the body fight infections. This condition is common in patients undergoing intensive chemotherapy or receiving a stem cell transplant because these treatments weaken the immune system.
Main focus: The study aims to compare two antibiotics, fosfomycin and ciprofloxacin, to determine which one is more effective at preventing febrile neutropenia. Both medications are taken orally as pills. Researchers want to find out if fosfomycin works as well as ciprofloxacin in protecting patients from infections during their treatment.
Investigational drugs: The trial tests two antibiotics:
- Fosfomycin – This antibiotic stops bacteria from growing by interfering with their ability to build cell walls, ultimately killing them. It is being studied to see if it can prevent infections in patients with weakened immune systems.
- Ciprofloxacin – This antibiotic kills bacteria by blocking their ability to replicate. It belongs to a class of drugs called fluoroquinolones and is commonly used to treat various bacterial infections.
Who can participate: The trial is open to adults aged 18 or older who have been diagnosed with acute leukemia and are about to start their first chemotherapy treatment or are candidates for their first stem cell transplant. Participants must be expected to have very low neutrophil levels lasting at least seven days. If neutrophil counts are expected to fall between 100 and 500, patients must have at least one additional risk factor for infection, such as:
- Expected severe mouth sores
- Being 65 years or older
- Having multiple other health conditions
- Low levels of a blood protein called albumin
- High doses of certain chemotherapy drugs like etoposide or cytarabine
- Active or hard-to-treat cancer at the time of transplant
Participants should be able to carry out most daily activities, with a performance status between 0 and 3. They must have adequate liver and kidney function, and their life expectancy should be more than three months. Women of childbearing age must not be pregnant or breastfeeding and must agree to use two effective forms of birth control during the study and for at least three months afterward.
Who cannot participate: Patients who are not at high risk of infection, do not have acute leukemia, are not undergoing intensive chemotherapy, or are not receiving stem cell transplantation are excluded from the study. The trial also excludes patients outside the specified age range and those considered part of vulnerable populations who might need special care.
What happens during the trial: When participants join the study, they will be randomly assigned to receive either fosfomycin or ciprofloxacin. The study team will explain the medication, including dosage and how often to take it. Throughout the trial, participants will have regular check-ups to monitor their health and response to the medication. Any side effects or health changes should be reported promptly to the study team. Participation will end when the neutrophil count reaches a certain level, after 60 days from the start of low neutrophil counts, or when a new cycle of chemotherapy begins, whichever comes first.
Summary
This clinical trial represents an important effort to improve infection prevention in patients with acute leukemia undergoing intensive treatments. The study is currently taking place in Spain and focuses specifically on comparing two antibiotic approaches to reduce the risk of febrile neutropenia, a potentially life-threatening complication. By testing fosfomycin against the commonly used ciprofloxacin, researchers hope to identify effective strategies to protect patients with weakened immune systems during critical phases of their treatment. The trial highlights the ongoing need to optimize supportive care for patients receiving chemotherapy and stem cell transplants.
