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Mycoses clinical trials

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NCT ID: NCT04774068 Active, not recruiting - Clinical trials for T-Cell Non-Hodgkin Lymphoma

Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas

Start date: September 1, 2021
Phase: Phase 1
Study type: Interventional

This phase I trial finds the appropriate parsaclisib dose level in combination with romidepsin for the treatment of T-cell lymphomas that have come back (relapsed) or that have not responded to standard treatment (refractory). The other goals of this trial are to find the proportion of patients whose cancer is put into complete remission or significantly reduced by romidepsin and parsaclisib, and to measure the effectiveness of romidepsin and parsaclisib in terms of patient survival. Romidepsin blocks certain enzymes (histone deacetylases) and acts by stopping cancer cells from dividing. Parsaclisib is a PI3K inhibitor. The PI3K pathway promotes cancer cell proliferation, growth, and survival. Parsaclisib, thus, may stop the growth of cancer cells by blocking PI3K enzymes needed for cell growth. Giving romidepsin and parsaclisib in combination may work better in treating relapsed or refractory T-cell lymphomas compared to either drug alone.

NCT ID: NCT04541017 Active, not recruiting - Mycosis Fungoides Clinical Trials

Testing the Addition of an Anti-cancer Drug, Hu5F9-G4 (Magrolimab), to the Usual Chemotherapy Treatment (Mogamulizumab) in T-Cell (a Type of Immune Cell) Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment

Start date: April 6, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This phase Ib/II trial identifies the best dose and possible benefits and/or side effects of magrolimab when given in combination with mogamulizumab in treating patients with stage IB-IV mycosis fungoides or Sezary syndrome types of T-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Magrolimab and mogamulizumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Treatment with magrolimab in combination with mogamulizumab may stabilize cancer for longer period than the usual treatment in patients with relapsed/refractory T-cell lymphoma who have been previously treated.

NCT ID: NCT04074746 Active, not recruiting - Clinical trials for Refractory B-Cell Non-Hodgkin Lymphoma

Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas

Start date: July 18, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and best dose of modified umbilical cord blood immune cells (natural killer [NK] cells) combined with the antibody AFM13 (AFM13-NK) and AFM13 alone in treating patients with CD30 positive Hodgkin lymphoma or non-Hodgkin lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as AFM13, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving AFM13 loaded with NK cells followed by AFM13 alone may kill more cancer cells and decrease cancer growth in patients with CD30 positive AFM13-NK Hodgkin and Non-Hodgkin lymphomas.

NCT ID: NCT03902184 Active, not recruiting - Clinical trials for Lymphoma, T-Cell, Cutaneous

IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma

TELLOMAK
Start date: May 22, 2019
Phase: Phase 2
Study type: Interventional

This is an open label, multi-cohort, and multi-center phase II study, which evaluates the clinical activity and safety of IPH4102 in Sezary Syndrome and Mycosis fungoides as single agent.

NCT ID: NCT03695471 Active, not recruiting - Mycosis Fungoides Clinical Trials

Pembrolizumab in Treating Patients With Stage IB-IV Mycosis Fungoides

Start date: December 20, 2018
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well pembrolizumab works in treating patients with stage IB-IV mycosis fungoides. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT03598998 Active, not recruiting - Clinical trials for Anaplastic Large Cell Lymphoma

Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas

Start date: February 4, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and best dose of pralatrexate when given together with pembrolizumab and how well they work in treating patients with peripheral T-cell lymphomas that has come back after a period of improvement or has not responded to treatment. Pralatrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab and pralatrexate may work better in treating patients with peripheral T-cell lymphomas.

NCT ID: NCT03385226 Active, not recruiting - Clinical trials for Cutaneous T Cell Lymphoma

A Trial Assessing the Effect of Pembrolizumab Combined With Radiotherapy in Patients With Relapsed, Refractory, Specified Stages of Cutaneous T-cell Lymphoma (CTCL) Mycosis Fungoides (MF)/Sezary Syndrome (SS)

PORT
Start date: January 15, 2019
Phase: Phase 2
Study type: Interventional

Trial Subjects (patients), will receive single infusions of pembrolizumab every 3 weeks until disease progression or unacceptable toxicity develops. They will receive radiotherapy at week 12.

NCT ID: NCT03278782 Active, not recruiting - Clinical trials for Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma

Study of Pembrolizumab (MK-3475) in Combination With Romidepsin

Start date: November 14, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects of pembrolizumab and romidepsin and to see how well they work in treating participants with peripheral T-cell lymphoma that has come back or that does not respond to treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and romidepsin may work better than pembrolizumab alone in treating participants with recurrent or refractory peripheral T-cell lymphoma.

NCT ID: NCT03267407 Active, not recruiting - HIV/AIDS Clinical Trials

Vietnam Cryptococcal Retention in Care Study - Version 2.1

Start date: August 14, 2015
Phase: N/A
Study type: Observational

This is a multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program at selected outpatient HIV clinics (OPCs) and network laboratories in Vietnam.

NCT ID: NCT03260634 Active, not recruiting - Fungal Infection Clinical Trials

The Study of Voriconazole Trough Level in the First Two Weeks After Administration in King Chulalongkorn Memorial Hospital.

Start date: January 1, 2016
Phase: N/A
Study type: Observational

Invasive fungal infections are a significant cause of morbidity and mortality in immunocompromised host such as prolong neutropenic patients , post transplantation patients, malignancies or advanced AIDS . The majority of these infections were caused by Aspergillus species, which the first line of treatment is antifungal agent, Voriconazole , a triazole antifungal drug which was approved by the Food and Drug Administration in May 2002 for the treatment of invasive aspergillosis and refractory infections of Scedosporium apiospermum and Fusarium spp. There are two forms of Voriconazole , oral and intravenous form. The recommendation dose is 6 mg/kg twice daily for two dosages, followed by 4 mg/kg twice daily in intravenous form or a loading dose of 400 mg twice daily for two doses is used (for individuals >40 kg), followed by 200 mg twice daily, and in individuals <40 kg the maintenance dose is 100 mg twice daily in oral form. Voriconazole has a narrow therapeutic window and nonlinear pharmacokinetic profile with wide inter-individual and intra-individual variability, such as age, race, genotypic variation, liver dysfunction, the presence of food and drug-drug interactions with CYP450 inhibitors. These large variations in pharmacokinetics may be associated with decreased efficacy or increased toxicity. Therefore , monitoring of serum trough concentrations is recommended in the following infections: invasive aspergillosis treatment , endophthalmitis; meningitis or osteoarticular infections due to Exserohilum rostratum. In Thai population , there are different genetic polymorphism from Caucasian ,resulting in a different response to the initial dose and there is limited resources in Thailand , mostly patients are unaccessible for Voriconazole level. Especially,in the period of starting drug, which is the critical period for patients ,most of them are post chemotherapy which may have gastrointestinal problems, mucositis , vomiting or diarrhea ,as well as receiving multiple concurrent medications. All of these affect drug absorption,drug level and efficacy of treatment. Thus, this study was designed to evaluated Voriconazole level in Thai patients in the first two week after administration. Primary question - From the first collected of Voriconazole drug level , Are the invasive fungal infection patients in King Chulalongkorn Memorial Hospital achieved the drug level more than 60% ? Secondary question - Which factor affecting Voriconazole through level in the first two weeks after administration? Research Design - Observational Studies (Descriptive retrospective and prospective study) Research Methodology Target Population - Patients received Voriconazole for treatment or prophylaxis invasive fungal infection Study population - Patients in King Chulalongkorn Memorial hospital received Voriconazole for treatment or prophylaxis invasive fungal infection Sample size n= ZZ/2P(1-P) /dd - n = sample size - P =Incident rate - From the pilot study of 15 Invasive fungal infection patients in King Chulalongkorn memorial hospital from February to September 2015 , 60% ( 9 of 15 patients) of the first collected of Voriconazole trough level achieved the therapeutic level. replaced P = 0.6 - Z = 95% confident interval = 1.96 - d = acceptable error = 0.10 n = (1.96) (1.96) (0.60)(1-0.60) / (0.10)(0.10) n =92 , sample size = 92 Study processing and data collection Data collection - Collected data of patients received Voriconazole in first two weeks of treatment or prophylaxis invasive fungal infection in King Chulalongkorn Memorial hospital in 2015-2017 from outpatient records , inpatient records and computer database in King Chulalongkorn Memorial hospital. This data included - Baseline characteristics : sex, age ,weight ,BMI ,co-morbid ,personal history of smoking or alcohol drinking - Basic laboratory investigation : complete blood count , Creatinin , liver function test , albumin level - Gastrointestinal problems - Indication of Voriconazole treatment - Data of invasive fungal infection : - Data of Voriconazole usage : Loading dose, Maintenance dose, Trough level , Data of drug adjustment, Concurrent medication used, Side effect - All data was summarized and recorded in case report forms. Data Analysis and Statistics The data was analysed by computer using SPSS17 program This study used descriptive statistics ,describing general information, age, results, laboratory results and side effects of the drug in mean ,percentage or standard deviation. And used the chi-square test for analysis of the proportion of patients with serum drug levels within the therapeutic range. This study used a confidence level of 95%, p-value less than 0.05 was statistically significant.