Study on Rezafungin to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation

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What is this study about?

This clinical trial is focused on studying the prevention of invasive fungal diseases in adults who are undergoing a type of blood and marrow transplant known as allogeneic transplantation. The study will compare the effectiveness and safety of a new treatment called Rezafungin for injection against the standard antimicrobial treatments currently used. The goal is to see if Rezafungin can help patients survive without fungal infections for 90 days after their transplant.

Participants in the study will receive either Rezafungin or the standard treatment. The standard treatment may include medications like Bactrim (which contains sulfamethoxazole and trimethoprim), Diflucan (fluconazole), and Noxafil (posaconazole). Some participants may receive a placebo, which looks like the real medication but does not contain any active ingredients. The study will monitor participants for 90 days to check for survival and the absence of fungal infections.

The study aims to determine if Rezafungin is as effective as, or better than, the standard treatments in preventing fungal infections. Participants will be closely monitored for any side effects or intolerances to the medications. The study will also track the number of fungal infections and any deaths that occur during the study period. This research is important for improving the care and outcomes of patients undergoing allogeneic blood and marrow transplants.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either rezafungin or the standard antimicrobial regimen. This assignment is done to compare the effectiveness of the two treatments in preventing fungal infections.

2 initial treatment phase

Participants receiving rezafungin will be administered the medication through an intravenous infusion. The dosage and frequency will be determined by the study protocol.

Participants receiving the standard antimicrobial regimen may receive medications such as posaconazole, fluconazole, or Bactrim in various forms including tablets, capsules, or injections. The specific medication, dosage, and frequency will depend on the standard treatment guidelines.

3 monitoring and follow-up

Throughout the study, participants will be monitored for any signs of fungal infections and overall health status. Regular check-ups and tests will be conducted to ensure safety and effectiveness of the treatment.

Participants will be assessed for fungal-free survival at Day 90, which is the primary goal of the study. This includes checking for survival, absence of fungal infections, and no need for additional antifungal treatments beyond the study medications.

4 completion of the study

At the end of the study period, participants will undergo a final evaluation to assess the outcomes of the treatment. This includes reviewing any side effects, the occurrence of fungal infections, and overall health status.

The study aims to determine if rezafungin is as effective or more effective than the standard regimen in preventing fungal infections in patients undergoing blood and marrow transplantation.

Who Can Join the Study?

Willing and able to provide written informed consent.
Females who can have children and are less than 2 years post-menopausal must use one barrier method of birth control (like a female condom with spermicide) plus another effective method (like birth control pills or an implant) or practice sexual abstinence during the study and for 30 days after the last dose of the study drug. Males must be vasectomized, abstain from sexual intercourse, or use barrier contraception (like a condom with spermicide) and agree not to donate sperm during the study and for 120 days after the last dose of the study drug.
Must be 18 years of age or older.
Receiving a human leukocyte antigen (HLA) matched allogeneic peripheral blood and marrow transplant (BMT) from a family or unrelated donor, HLA-mismatched related or unrelated donor, or haploidentical donor. HLA is a protein that helps the body recognize its own cells.
Diagnosed with one of the following diseases:
- Acute myeloid leukemia (AML) in first or second complete remission.
- Acute lymphoblastic leukemia in first or second complete remission.
- Acute undifferentiated leukemia in first or second remission.
- Acute biphenotypic leukemia in first or second complete remission.
- Chronic myelogenous leukemia in chronic or accelerated phase.
- Myelodysplastic syndromes, which are a group of disorders caused by poorly formed or dysfunctional blood cells.
- Lymphoma with chemosensitive disease, meaning it responds to chemotherapy.
- Aplastic anemia, a condition where the body stops producing enough new blood cells.
- Primary or secondary myelofibrosis, a disorder of the bone marrow.
- Chronic myelomonocytic leukemia.
- Chronic lymphocytic leukemia.
- Drepanocytosis, also known as sickle cell anemia.
- Red blood cell aplasia, a condition where the body stops producing red blood cells.
- Myeloproliferative disorder, unclassified.
- Multiple myeloma, a cancer of plasma cells.
Receiving myeloablative or reduced-intensity conditioning regimens. Myeloablative means treatments that destroy bone marrow cells.
Have adequate liver and kidney function before starting the conditioning regimen, which is between 40 days and 10 days before the BMT. This means:
- Liver: alanine aminotransferase (a liver enzyme) should be no more than 2.5 times the upper limit of normal, and total serum bilirubin (a substance made by the liver) should be no more than 1.5 times the upper limit of normal, excluding Gilbert’s Syndrome.
- Kidneys: serum creatinine (a waste product in the blood) should be no more than 2 mg/dL, and creatinine clearance (a measure of kidney function) should be at least 30 mL/min without a history of kidney transplant or undergoing weekly dialysis within 4 weeks of the BMT.
Baseline blood samples for specific tests (serum Platelia galactomannan enzyme immunoassay and β-D-glucan levels) must be taken within 15 days before randomization, with results available before randomization.
Baseline Toxoplasma serologies (blood tests for a specific infection) must be available within 6 weeks before randomization. If a subject has a positive Toxoplasma IgG serology at any time before randomization, they do not need to repeat the tests and will be considered to have a prior history of toxoplasmosis.
Baseline glucose-6-phosphate dehydrogenase (G6PD) deficiency determination must be done by the investigator before randomization, with no evidence of known G6PD deficiency. If the investigator assesses the subject as G6PD sufficient, the test result does not need to be entered into the electronic data capture system.

Who Cannot Join the Study?

Patients who have a known allergy or severe reaction to the study medication or similar drugs.
Patients who are currently participating in another clinical trial or have recently participated in one.
Patients with a history of certain serious medical conditions that could interfere with the study, such as severe liver or kidney disease.
Patients who are pregnant or breastfeeding.
Patients who have a current infection that requires treatment with certain medications that could interfere with the study.
Patients who have received certain treatments or medications that could affect the study results within a specific time frame before the study starts.
Patients who have a history of substance abuse or other conditions that could affect their ability to follow the study procedures.
Patients who have any other condition that, in the opinion of the study doctor, makes them unsuitable for participation in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Katholieke Universiteit te Leuven	Leuven	Belgium
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Hospital Clinico Universitario De Valencia	Valencia	Spain
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Otto Von Guericke Universitaet Magdeburg	Magdeburg	Germany
Hifemykm Uindxlvkjxrno Mjpuskm Dz Vdhcgzmwxi	Santander	Spain
Ikffkuwo Cvvhyc Dovptjilkswquvani	L'hospitalet De Llobregat	Spain
Umhcobzugr Hgdsxfkk Chhabpt	Cologne	Germany
Ctjohh Hipfvpgtuem Ek Umspihbqkrauy Dp Lvwbeko	Limoges	France
Bpghnmvy Uakhodfvoh Hhobgqyl Ckbgyt	Besançon	France
Udxvfrnyclqevqfiulfjc Mntsjnlf Axi	Munster	Germany
Ucxvoouertinhxpqhskov Wbqudilup Ato	Wuerzburg	Germany
Hpensakx Vrnh dpkhuiws	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	11.05.2020
France	Not recruiting	11.05.2020
Germany	Not recruiting	11.05.2020
Italy	Not recruiting	11.05.2020
Spain	Not recruiting	11.05.2020

Trial locations

Investigated drugs:

Rezafungin for Injection is a medication being studied to prevent invasive fungal diseases in adults who have undergone a blood and marrow transplant. It is being compared to the standard treatment to see if it is as effective or better at keeping patients free from fungal infections 90 days after their transplant.

Standard Antimicrobial Regimen (SAR) refers to the usual treatment given to prevent fungal infections in patients who have had a blood and marrow transplant. This regimen is used as a comparison to evaluate the effectiveness of Rezafungin in preventing these infections.

Invasive Fungal Diseases – These are serious infections caused by fungi that invade the body, often affecting individuals with weakened immune systems, such as those undergoing allogeneic blood and marrow transplantation. The disease can progress rapidly, leading to severe complications if not managed promptly. Common fungi involved include species like Candida, Aspergillus, and Pneumocystis jirovecii. Symptoms may vary depending on the affected area but often include fever, cough, and difficulty breathing. The disease can spread to various organs, causing systemic issues. Early detection and management are crucial to prevent further complications.

Trial ID:

2024-514471-18-00

Protocol code:

CD101.IV.3.08

NCT ID:

NCT04368559

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Rezafungin to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?