507 Clinical Trials for Various Conditions
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.
This study will collect data on the incidence (rate of occurrence) of fungal infections in recipients of bone marrow, stem cell or organ transplants. The data will provide information needed to develop strategies for prevention and early treatment of fungal infections in these patients. Any patient receiving bone marrow transplantation, peripheral stem cell transplantation or solid organ transplantation is eligible for this study. The survey will be conducted over a 3-year period at about 20 collaborating transplant centers. Through the annual accrual of more than 9,000 patients, it is estimated that at least 5 to 8 percent per year will have documented or suspected invasive fungal infections. The study will be conducted in three phases as follows: * Phase 1 A 6-month "start-up" phase during which sites will initiate screening and begin collecting data on incident cases of invasive fungal infections. * Phase 2 A 2-year phase in which all sites will conduct surveillance and collect data and specimens in a standardized fashion. * Phase 3 A 6-month "wrap-up" phase during which active surveillance for invasive fungal infections will be conducted only among patients who were transplanted before the beginning of this phase. Patient care will be provided through the patient s primary protocol and standard of care. ...
The major morbidities of allogeneic hematopoietic stem cell transplant (HSCT) using donors that are not human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life- threatening infections. T cell receptor alpha beta (TCRαβ) T lymphocyte depletion and CD19+ B lymphocyte depletion of alternative donor hematopoietic stem cell (HSC) grafts is effective in preventing GVHD, but immune reconstitution may be delayed, increasing the risk of infections. The central hypothesis of this study is that an addback of CD45RO memory T lymphocytes, derived from a fraction of the original donor peripheral stem cell product depleted of CD45RA naïve T lymphocytes, will accelerate immune reconstitution and help decrease the risk of infections in TCRab/CD19 depleted PSCT.
This project aims to address invasive fungal infections in patients with blood cancer, by precision dosing of voriconazole based on CYP2C19 genotype testing with Bayesian dose-forecasting dosing software to develop patient-centric and maximally effective dosing regimens. This study investigates if voriconazole increases the proportion of patients achieving therapeutic exposure at day 8 of dosing compared with standard care; and will assess factors that influence the implementation of genotype testing and dosing software in the healthcare system, including fidelity, feasibility, acceptability and cost-effectiveness. It will recruit at least 104 kids and adults in a parallel-group randomised clinical trial. A hybrid feasibility sub-study will assess the scalability of genotype-directed dosing to ensure sustainable integration of the interventions into the clinical workflow. A health economic sub-study will evaluate the costs, health outcomes and cost-effectiveness of genotype-directed testing compared to standard care.
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen.
The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype in subjects who have confirmed disease progression following treatment with vorinostat in the SOLAR clinical study (MRG106-11-201). Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells. The effects of treatment will be measured based on changes in skin lesion severity, disease-associated symptoms, and quality of life, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects.
The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype. Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells. The study will compare the effects of cobomarsen to vorinostat, a drug that has been approved for the treatment of CTCL in the United States and several other countries. Participants in the clinical trial will be randomly assigned to receive either weekly doses of cobomarsen by injection into a vein or daily oral doses of vorinostat. Participants will continue on their assigned treatment as long as there is no evidence of progression of their cancer. The effects of treatment will be measured based on changes in skin lesion severity, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects. Participants assigned to receive vorinostat who experience progression of their disease during their participation in this study may have the option to be treated with cobomarsen in an open-label, crossover arm of the same study if they meet the entry criteria for that part of the study.
This was an open-label study to evaluate the safety and pharmacokinetics of tavaborole 5% topical solution in treating distal subungual onychomycosis (a fungal infection) of the toenail in children and adolescents (ages 6 to 16 years). Following confirmation of eligibility, including laboratory evidence of a fungal organism in the toenail, tavaborole topical solution was applied once daily to all affected toenails for a 48-week treatment period. Clinical assessment of the extent of infection and safety assessments were performed periodically throughout the 48-week treatment period, and again at 52 weeks (4 weeks after stopping the treatment). A subgroup of enrolled subjects applied the topical solution to all 10 toenails and a small area of surrounding skin during the first 28 days. These subjects had blood samples analyzed to evaluate the pharmacokinetics (how the drug moves in the body) of tavaborole topical solution in children and adolescents.
The goal of this clinical research study is to learn if SGN-35 (brentuximab vedotin) can help to control ALCL, LyP or MF in patients with at least 1 of the 3 skin lymphomas. The safety of the study drug will also be studied.
Background: - Researchers are interested in studying disorders that make individuals more susceptible to fungal infections, specifically infections with the Candida yeast. These disorders are often related to problems with the immune system and may have genetic factors, which suggests that researchers should study not only the individual with the disorder, but also his or her first- and second-degree relatives (such as parents, siblings, children, and first cousins). To provide material for future research, individuals with immune disorders and their first- and second-degree relatives will be asked to provide blood and other samples for testing and comparison with samples taken from healthy volunteers with no history of immune disorders. Objectives: - To collect blood and other biological samples to study immune disorders that make individuals more susceptible to fungal infections. Eligibility: * Individuals of any age who have abnormal immune function characterized by recurrent or unusual fungal infections, recurrent or chronic inflammation, or other types of immune dysfunction. * First- or second-degree genetically related family members (limited to mother, father, siblings, grandparents, children, aunts, uncles, and first cousins). * Healthy volunteers at least 18 years of age (for comparison purposes). Design: * Participants will provide blood samples and buccal (cells from the inside of the mouth near the cheek) samples. * Participants with immune disorders will also be asked to provide urine samples, saliva or mucosal samples, or skin tissue biopsies, and may also have imaging studies (such as x-rays) to collect information for research. * Samples may be collected at the National Institutes of Health or at other clinical locations for the samples to the sent to the National Institutes of Health. * No treatment will be provided as part of this protocol.
The purpose of this study is to compare the efficacy of anidulafungin versus fluconazole for the prevention of fungal diseases in liver transplant recipients
Approximately 40 qualified subjects with mild-to-moderate great toenail fungus infection will be treated for 48 weeks with lacquer application to at least one affected great toenail. All subjects will receive treatment with EcoNail™ lacquer.
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using silicon phthalocyanine 4 may be effective against skin cancer. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using silicon phthalocyanine 4 in treating participants with actinic keratosis, Bowen's disease, skin cancer, or stage I or stage II mycosis fungoides.
RATIONALE: Antifungals, such as voriconazole and itraconazole, may be effective in preventing fungal infections in patients who are undergoing allogeneic stem cell transplantation. PURPOSE: This randomized clinical trial is studying voriconazole to see how well it works compared to itraconazole in preventing fungal infections in patients who are undergoing allogeneic hematopoietic stem cell transplantation.
The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
RATIONALE: Antifungals such as ravuconazole may be effective in preventing fungal infections in patients undergoing chemotherapy and stem cell transplantation. PURPOSE: Phase I/II trial to study the effectiveness of ravuconazole in preventing fungal infections in patients undergoing allogeneic stem cell transplantation.
This study will evaluate the safety and effectiveness of posaconazole for treating invasive fungal infections. New therapies for these infections are needed for patients who do not respond, to or cannot tolerate, standard treatment. These patients include those with immune defects who have significant side effects from treatment with amphotericin or other antifungals. Patients 13 years of age or older who are on other primary NIH protocols with an invasive fungal infection 1) that does not respond to standard antifungal therapies; 2) for which there is no effective therapy; 3) who develop serious side effects from their current treatment; or 4) who have organ dysfunction that does not permit use of standard antifungal treatments may be eligible for this study. Candidates will be screened with a medical history, including a review of current and previous antifungal treatments, pregnancy test for women of childbearing potential, electrocardiogram (EKG), and detailed neurologic examination. Participants will take either 200 mg (1 teaspoonful) of liquid posaconazole by mouth four times a day or 400 mg (two teaspoonfuls) twice a day for a period of 28 days to 24 months. (The physician will determine the duration of treatment.) Patients will have monthly follow-up visits during the treatment period and 1 month after treatment is completed for the following procedures: * Detailed neurologic exam every 3 months * Blood tests every month * EKG every month * Imaging studies, including chest x-ray, computed tomography (CT), magnetic resonance imaging (MRI) radionuclide scanning or ultrasound, every month until the infection has been stable for three determinations. Thereafter, imaging studies will be done every 3 months as long as the infection remains stable or improves. On the last day of the study treatment period, participants will have a detailed neurologic exam and review of medications and medical complaints since their last visit.
This study will examine how children's bodies metabolize and eliminate the anti-fungal drug voriconazole. The results will yield information needed to make recommendations for safe and effective dosing of the drug in children. Children with reduced immune function-such as those receiving drugs for cancer treatment-are at high risk for serious fungal infections. Children between 2 and 12 years old who need treatment to prevent fungal infections may be eligible for this study. Candidates will be screened with a physical examination, eye examination, and blood and urine tests. Children in the study will be hospitalized for 21 days. They will receive voriconazole twice a day (every 12 hours) for 8 days, infused through a vein over a period of 1 to 2 hours. The dose will be determined based on the individual child's weight. Blood samples will be collected at various intervals before and after the infusions on days 1, 2, 4 and 8 to determine the amount of drug in the blood. On day 8, the child will have another physical and eye examination, as well as additional blood and urine tests. If additional treatment is required, voriconazole may be continued for up to day 21. (Children who require the drug for more than 21 days may receive it under another research protocol.) On the last day of treatment, the child will have another physical examination, and blood and urine tests. These procedures will be repeated again at 30 to 35 days following the last dose of drug. A small sample of blood will also be analyzed for genetic information related to the rate of metabolism of voriconazole-that is, how fast or slow it is cleared (eliminated) by the liver. Voriconazole is effective against several different fungi. It may protect children against serious fungal infections with fewer side effects than standard available therapy.
This protocol describes a prospective, randomized study examining the safety and efficacy of Itraconazole for preventing fungal infections in patients with Chronic Granulomatous Disease (CGD). CGD is a genetic disorder in which phagocytes are unable to produce oxygen radicals. As a result, affected patients are prone to recurrent, severe infections with bacterial and fungal organisms. Patients with CGD of 5 or more years of age without evidence of infection at the time of study entry will be eligible for enrollment. Patients will be randomized to receive itraconazole or placebo tablets daily, in a double blinded fashion. In addition to itraconazole, all patients will receive antimicrobial prophylaxis against bacterial infection, and may in addition receive gamma-interferon as prophylaxis against infection. Randomization of patients will be stratified among patients receiving or not receiving gamma interferon. The primary endpoint of the study will be the development of culture or histologically proved invasive fungal disease. Patients will be monitored every three months for evidence of drug toxicity. The anticipated accrual period will be approximately 36-48 months.
This study is being done to assess mogamulizumab-associated rash in patients diagnosed with mycosis fungoides or sezary syndrome and treated with standard of care mogamulizumab. One of the most common side effects of mogamulizumab is a rash, currently named mogamulizumab-associated rash (MAR) which can look like MF or SS. However, mogamulizumab-associated rash (MAR) does not indicate failure of mogamulizumab, and may be a sign that the drug is working. If not properly evaluated, mogamulizumab-associated rash (MAR) could be misinterpreted as worsening of mycosis fungoides/sezary syndrome, which could lead doctors to recommend stopping mogamulizumab treatment early. The information learned by doing this research study may help tell the difference between mogamulizumab-associated rash (MAR) (sometimes also called "drug eruption") and worsening of the disease. It may also help to uncover information about the cause of mogamulizumab-associated rash (MAR).
To follow up with all our participants with juvenile-onset mycosis fungoides, check on their status, and ask them or their parents about long term outcomes associated with their condition.
The hypotheses of this study are that single agent CPI-0209 will be safe and well tolerated in patients with advanced (stage IB-IVB) mycosis fungoides (MF)/Sézary syndrome (SS) who have had at least one prior systemic therapy, and that in these patients, CPI-0209 will demonstrate efficacy and be worth of further study.
The goal of this clinical trial is to assess the benefit of continuous treatment with synthetic hypericin ointment (HyBryte) and visible light in patients with mycosis fungoides for up to 12 months (54 weeks). Funding Source: FDA OOPD.
Mycosis fungoides (MF) is the most common subtype of cutaneous T cell lymphoma (MF) and presents as cutaneous patches, plaques, and tumors. Radiation therapy (RT) is a frequently pursued management option for CTCL, especially in patients with more advanced skin disease. Imiquimod stimulates a Th1 lymphocyte response with increased IL-2 and IFN-α, but also induces IFN-α, TNF-α, IL-1α, IL-6, and IL-8, thereby bridging both innate and adaptive immunity. Dosing of both radiotherapy (RT) and imiquimod are based on standard-of-care doses/frequencies for CTCL. The reason imiquimod topical is given for a week before giving RT is to prime innate immune activity for when RT is delivered. It is believed that this serves as an adjuvant for the CD8+ antitumor response generated by RT. The primary aim of this study is to assess the safety and efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF.
Corticosteroids exposure is a common risk factor for invasive fungal infections. Systemic corticosteroid therapy treats several medical conditions, including rejection in solid organ transplant recipients, malignancy, and autoimmune or inflammatory diseases. Corticosteroid exposure is a well-known risk factor for developing PJP. Still, it remains unclear how prior corticosteroid exposure influences the presentation, severity, and mortality of opportunistic fungal infections. The investigators aim to prospectively characterize the corticosteroid use as a dose response to inform risk of invasive fungal infections.
The purpose of this study is to determine whether photopheresis therapy can be used to improve the clinical course of early stage cutaneous T-cell lymphoma (CTCL). Currently, photopheresis is performed as a palliative treatment for late stage CTCL. However, recent studies have demonstrated that patients with early stage CTCL may have markers in their blood which were previously observed primarily in late stage disease, such as clonal T cell populations. Considering these findings, the study aims to investigate whether photopheresis therapy may be used earlier in the disease course to produce a clinical response.
This is an open label, single center, non-randomized dose de-escalation phase I study of combination of BV and Mogamulizumab. The primary objective of the study is to assess the safety and tolerability of the combination. The primary objective is also to explore safe dose of combination for future expansion.
To learn if a form of radiation therapy (called ultra-low-dose - total skin electron beam therapy \[ULD-TSEBT\]) in combination with brentuximab vedotin can help to control mycosis fungoides
The researchers are doing this study to test the safety of combining bexarotene with TSEB radiotherapy in people who have a common form of CTCL called mycosis fungoides (MF). Bexarotene is a form of vitamin A that activates proteins called retinoid X receptors, which may stop the growth of cancer cells and kill them. TSEB radiotherapy is a type of radiation therapy that treats the entire surface of the skin with very low doses of radiation to kill cancer cells and shrink tumors. This type of radiation does not pass through the outer layers of the skin into the tissues and organs below the skin. The study researchers think that giving bexarotene treatment at the same time as treatment with TSEB radiotherapy may be more effective against MF than either treatment given alone or in sequence (one after the other).
The goal of the current study is to evaluate the ability of CGB-400, a proprietary eutectic mixture of GRAS compounds, to clear the toenail fungal growth and improve the appearance of the fungus affected area(s). This is an open-label, single group POC study evaluating the effectiveness of CGB-400 Topical Gel for toenail fungal growth clearing. The study consists of a 12-week period with 5 clinic visits at the following timepoints: Baseline (Day 0), and Weeks 2, 6, and 12 and post-application follow-up at Week 24. The applications could be extended for an additional 12 weeks based on PI's observations. Approximately 15 subjects will be enrolled and subjected to application of CGB-400 Topical Gel. Subjects must be at least 18 years of age and will be selected by the concerned PI.