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Neutropenia clinical trials

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NCT ID: NCT01569087 Completed - Clinical trials for Chemotherapy-induced Neutropenia

Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Cancer Patients

Start date: May 2012
Phase: Phase 2
Study type: Interventional

BCD-017-2 is an open-label randomized phase II clinical study to compare the incidence of CTCAE grade 3/4 neutropenia after a single administration of recombinant human pegylated filgrastim empegfilgrastim (Extimia®) at a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients receiving myelosuppressive chemotherapy.

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: NCT01529827 Completed - Clinical trials for Chronic Myelomonocytic Leukemia

Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Start date: February 28, 2012
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic malignancies. Giving chemotherapy drugs such as fludarabine phosphate and melphalan, and low-dose TBI before a donor PBSCT helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from the donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cell from a donor can make an immune response against the body's normal cells. Giving tacrolimus, mycophenolate mofetil (MMF), and methotrexate after transplant may stop this from happening

NCT ID: NCT01519700 Completed - Breast Cancer Clinical Trials

Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim

PIONEER
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

NCT ID: NCT01516736 Completed - Breast Cancer Clinical Trials

Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim

PROTECT2
Start date: March 2012
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy of LA-EP2006 compared to Peg-Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

NCT ID: NCT01484015 Completed - Breast Cancer Clinical Trials

Prolonged or Standard Infusion of Cefepime Hydrochloride in Treating Patients With Febrile Neutropenia

Start date: February 2011
Phase: Phase 1
Study type: Interventional

This randomized pilot clinical trial studies how well giving prolonged infusion compared to standard infusion of cefepime hydrochloride works in treating patients with febrile neutropenia. Giving cefepime hydrochloride over a longer period of time may be more effective than giving cefepime hydrochloride over the standard time.

NCT ID: NCT01459653 Completed - Breast Cancer Clinical Trials

Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor

Monitor-GCSF
Start date: March 2010
Phase: N/A
Study type: Observational

This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for primary or secondary FN prophylaxis to better describe the patient population at risk for FN and treated prophylactically in physician's best clinical judgement with filgrastim biosimilar (EP2006), to describe prophylaxis patterns involving filgrastim biosimilar (EP2006), and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and experience break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which prophylaxis of FN is in congruence with guideline recommendations.

NCT ID: NCT01450241 Withdrawn - Febrile Neutropenia Clinical Trials

Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia

Start date: January 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether short-course antibiotic therapy is safe and effective for the treatment of cancer patients with febrile neutropenia.

NCT ID: NCT01431326 Completed - Hypertension Clinical Trials

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

PTN_POPS
Start date: November 2011
Phase:
Study type: Observational

Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

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.