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Neutropenia clinical trials

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NCT ID: NCT01658956 Recruiting - Breast Cancer Clinical Trials

Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia

PAPALDO
Start date: July 2012
Phase: Phase 2
Study type: Interventional

The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.

NCT ID: NCT01560195 Recruiting - NSCLC Clinical Trials

A Study of Pegylated rhG-CSF as Support to Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy Receiving Chemotherapy

Start date: April 2012
Phase: Phase 3
Study type: Interventional

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with advanced NSCLC.

NCT ID: NCT01417169 Recruiting - Neutropenia Clinical Trials

Micafungin Prevention Study for Invasive Fungal Disease in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation

Start date: August 2011
Phase: Phase 2
Study type: Interventional

This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.

NCT ID: NCT01135589 Recruiting - Neutropenia Clinical Trials

Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation

Start date: April 2010
Phase: Phase 4
Study type: Interventional

This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.

NCT ID: NCT00967785 Recruiting - Infections Clinical Trials

A Phase I Study of Mozobil in the Treatment of Patients With WHIMS

Start date: January 6, 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - WHIMS (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome) is caused by various genetic changes that increase the activity of the chemokine receptor, CXCR4. Excessive function of this receptor causes mature neutrophils (part of the white blood cells) to be retained within the bone marrow rather than being released to the blood and is one of the causes of severe inherited neutropenia (low white blood counts). In neutropenia, the body is less able to fight off infection. Patients with WHIMS usually are at risk for skin, soft tissue, sinus, and lung infections, which can result in loss of hearing, teeth, and lung function. - Current treatment for WHIMS consists of regular injections of a white blood cell growth stimulating medication called granulocyte colony stimulating factor (G-CSF), and supplemental immunoglobulin (antibody). These therapies are expensive, nonspecific, have significant side effects and toxicities, and do not fully correct all problems, especially warts and cancers related to human papillomavirus (HPV). - A drug called Mozobil has been approved for use in combination with G-CSF to increase the number of stem cells that can be collected prior to bone marrow transplantation. Mozobil may offer a specific and well-tolerated new treatment for WHIMS and other syndromes characterized by neutropenia. Objectives: - To evaluate whether Mozobil is safe and effective to treat neutropenia (low white blood cell count) in patients with WHIMS. - To determine an appropriate treatment dose of Mozobil, within currently approved dosage levels. Eligibility: - Individuals between 18 and 75 years of age who have been diagnosed with WHIMS and have a history of severe infections. Design: - Potential participants will undergo a screening with a medical history, physical examination, questionnaire, heart and lung function scans, and blood and urine samples. Tests will also be done for hepatitis B and C virus, and human immunodeficiency virus (HIV) that causes acquired immunodeficiency syndrome (AIDS), as well as to check neutrophil function. - Patients who are being treated with G-CSF will stop injections for 2 days before being admitted to the National Institutes of Health (NIH) Clinical Center. - Patients may participate in a Dose Escalation study and receive increasing doses of Mozobil over 5 days of treatment until their white blood cell count improves sufficiently or the maximum approved dose is reached. Blood samples will be taken regularly throughout the treatment process. Patients will then receive an additional dose of Mozobil at the maximum approved dose or the dose sufficient to cause improvement, before restarting the G-CSF injections. - Patients may also participate in a long-term Chronic Dosing study and receive Mozobil once or twice a day for up to a maximum of 60 months.

NCT ID: NCT00673348 Recruiting - Neutropenia Clinical Trials

Therapeutic Drug Monitoring (TDM) of Voriconazole and Correlation With CYP2C19 Genotype in Korean Populations

Start date: May 2008
Phase: N/A
Study type: Observational

Voriconazole (VCZ), the antifungal drug active against Candida and Aspergillus is a substrate of CYP2C19, whose proportion of poor metabolizers is about ~20% in Asian population. The AUC's of VCZ differs over 4 folds by CYP2C19 genotypes of homozygotic wild type, heterozygote, and homozygotic poor metabolizers. The Asian population enrolled in the metabolism of VCZ were mainly Japanese and Chinese, without Korean subjects. The proportion of poor metabolizers in Korean population is known to be around 12% (Pharmacogenetics. 1996 Dec;6(6):547-51). The importance of CYP2C19 genotypes on the pharmacokinetics (PK) of voriconazole is well established, Hence, it is desirable to individualize the dosage regimen of VCZ according to the genotypes of patients. Fungal infection in immunocompromised patients is a life threatening condition which needs critical care. Although the PK change by genotypes are well known, its clinical implication or need for different dosage regimen by genotypes is not established, yet.

NCT ID: NCT00555516 Recruiting - Breast Cancer Clinical Trials

A Pilot Study to Evaluate the Safety and Activities of EW02 in Reducing Neutropenia Caused by Chemotherapy

Start date: November 2007
Phase: Phase 1/Phase 2
Study type: Interventional

Study Hypothesis: EW02 is a polysaccharide-enriched crude extract from black soybean (BS). BS has been used extensively by the Chinese as food or traditional Chinese medicine for hundreds of years. It has been used as monotherapy to treat Diabetes, menorrhagia and leukorrhea. In combination with others, BS has been used to treat chemotherapy-induced leukopenia on more than 300 pts. The daily doses were 15g bid to 50g tid for 21 days. Side effects were generally mild, including epigastric discomfort, numbness, insomnia, and dry mouth. Recently BS was found to promote myelopoiesis and inhibit tumor growth through immunomodulation. In vitro assays showed BS-PS can stimulate production of cytokines and increase blood progenitors. In vivo studies also demonstrated that BS-PS can reduce neutropenia in mice received 5-FU by stimulating myeloid colony formation. We hypothesize that EW02 can reduce neutropenia in cancer patients who receive chemotherapy without side effects.

NCT ID: NCT00501332 Recruiting - Breast Cancer Clinical Trials

Evaluation of Maxy-G34 in Breast Cancer Patients Treated With TAC (Docetaxel, Adriamycin, Cyclophosphamide) Chemotherapy

Start date: July 2007
Phase: Phase 2
Study type: Interventional

This is an investigation of the safety and efficacy of Maxy-G34 in breast cancer patients treated with TAC chemotherapy. Maxy-G34 will be given as a single injection during each cycle of chemotherapy, for a planned total of six chemotherapy cycles.

NCT ID: NCT00445497 Recruiting - Lymphoma Clinical Trials

Early Hospital Discharge or Standard Inpatient Care in Cancer Patients Receiving Antibiotics for Febrile Neutropenia

Start date: July 2007
Phase: Phase 3
Study type: Interventional

RATIONALE: Finishing an antibiotic regimen at home may be as effective as receiving it in the hospital. It is not yet known whether early hospital discharge is as effective as standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia. PURPOSE: This randomized phase III trial is studying early hospital discharge and comparing it with standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia.

NCT ID: NCT00247039 Recruiting - Neutropenia Clinical Trials

Garlic in Patients With Febrile Neutropenia

Start date: June 2006
Phase: Phase 1/Phase 2
Study type: Interventional

To determine the clinical effects of garlic in preventing and treatment of patients with chemotherapy related febrile neutropenia.These patients have a very high incidence of infections which are not routinely covered by the standard empiric therapy. Adding a non- toxic and possibly effective therapy may reduce the risk for infections, synergize the empiric antibiotic treatment and may lessen the need for broader spectrum and more severe side effects.