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Neutropenia clinical trials

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NCT ID: NCT03233776 Completed - Multiple Myeloma Clinical Trials

Anakinra: Safety and Efficacy in the Management of Fever During Neutropenia and Mucositis in ASCT

AFFECT-1
Start date: August 21, 2017
Phase: Phase 2
Study type: Interventional

Oral and intestinal mucositis are major risk factors for the occurrence of fever during neutropenia and bloodstream infections after intensive chemo- and radiotherapy. These complications often require dose reductions or cause delay of treatment, and thereby interfere with optimal anticancer treatment. Currently, there are no effective strategies to prevent or treat mucositis and the related complications. The pro-inflammatory cytokine interleukin-1β (IL-1β) has shown pivotal in the pathogenesis of mucositis and recently, it has been established in murine models that IL-1 inhibition significantly ameliorates chemotherapy-induced intestinal mucositis. In this phase IIa study the safety, maximum tolerated dose and efficacy of anakinra, a recombinant human IL-1 receptor antagonist, will be determined in adult patients with multiple myeloma who receive high-dose melphalan (HDM) in the preparation for an autologous hematopoietic stem cell transplantation (ASCT) and are at high risk for experiencing mucositis and fever during neutropenia (FN). After establishing the optimal dose, a pivotal double-blind randomized placebo-controlled multicenter phase IIb trial will be planned to establish efficacy.

NCT ID: NCT03217721 Completed - Clinical trials for Neutropenia, Febrile

Antibiotics Management of Septic Neutropenic Patients in the Intensive Care Unit

REANEUF
Start date: June 19, 2017
Phase: N/A
Study type: Observational

Neutropenia, defined by an absolute count of polymorphonuclear neutrophils less than <1500/mm3, exposes patients to infectious complications that can lead to sepsis or septic shock. The mortality risk is higher risk. The recommendations published in 2016 were formulated to homogenize the clinical practices to improve the survival.

NCT ID: NCT03208816 Completed - Depression Clinical Trials

Community-Led Action Research in Oncology: Improving Symptom Management

CLARO
Start date: July 24, 2017
Phase: N/A
Study type: Interventional

This study will be conducted at La Liga Contra el Cancer in San Pedro Sula, Honduras. The overall objective of this project is to improve symptom management for patients undergoing chemotherapy in Honduras. The first step in this line of research is a "proof of concept" feasibility study in which the investigators will demonstrate their ability to train nurses to administer a non-pharmacological, telephone-delivered, symptom management program for chemotherapy patients.

NCT ID: NCT03104595 Completed - Febrile Neutropenia Clinical Trials

Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer

Start date: October 30, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

To assess the safety and establish the dose to assess the pharmacokinetic activity following administration of EC-18 in patients with advanced breast cancer receiving low febrile neutropenia risk chemotherapy who are the candidates for second-line or higher combination therapy with doxorubicin and cyclophosphamide.

NCT ID: NCT03102606 Completed - Clinical trials for Chemotherapy-induced Neutropenia

Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3

Protective-1
Start date: May 29, 2018
Phase: Phase 3
Study type: Interventional

To assess Duration of Severe Neutropenia (DSN) in treatment Cycle 1 in patients with advanced or metastatic breast cancer, who have failed >/= 1 but < 5 prior lines of chemotherapy; locally advanced or metastatic non small cell lung cancer (NSCLC) after platinum therapy failure; or hormone refractory (androgen independent) metastatic prostate cancer treated with docetaxel (75 mg/m2) + plinabulin (40 mg) versus docetaxel (75 mg/m2) + pegfilgrastim (6 mg). Neutrophils count will be assessed at baseline; Pre dose during Cycle 1, Day 1, 2, 6, 7, 8, 9, 10, 15. *Study is officially closed on 08 Feb 2021*

NCT ID: NCT03087227 Completed - Solid Tumor Clinical Trials

Shared Health Information System for Febrile Neutropenia

NEUTROSIS
Start date: February 22, 2017
Phase: N/A
Study type: Interventional

The use of e-health in improving the quality of health services is a rapidly expanding research area, in particular its usefulness in patient management of the home-hospital care pathway. Febrile neutropenia is a serious and frequent complication of cytotoxic chemotherapy and better identification of low-risk patients who can be treated at home could be made possible by these technologies. The objective of this study is to evaluate a shared health information system (NEUTROSIS) for home-hospital management of febrile neutropenia after anti-tumor chemotherapy. The study aims to compare the average length of hospital stay for febrile neutropenia among patients receiving NEUTROSIS and those receiving standard care Materials and methods A shared information system (NEUTROSIS) has been developed to connect a smartphone web application for the patient to the existing shared medical record of the Paris Sud hospital group (AP-HP, France - 4D software). The study consists of conducting a randomized controlled trial to compare a cohort of patients receiving cytotoxic chemotherapy for solid cancer or heamatological malignancies using the NEUTROSIS shared information system (n=100) and a cohort of patients followed by the hospital's standard care over a treatment period of six months (n=100). During the 15 days following each chemotherapy cycle, the 2 groups of patients must take their temperature daily. Both groups are trained like any patient under chemotherapy to contact the team in case of fever. The NEUTROSIS group captures daily its temperature and the occurrence of other symptoms on the smartphone application. This information is then transmitted instantly to the hospital care team who will be alerted in case of fever and will contact the patient. The control group will indicate these same data in a paper diary and will have to contact the health team in case of fever as done in the usual care. The two groups of patients will be followed 6 months through a questionnaire asked to the patient at each hospital visit for chemotherapy cycle. The questionnaire collects information on the occurrence of symptoms and healthcare use between two chemotherapy cycles. A last follow-up questionnaire is asked by phone at the endpoint follow-up (6 months). The study will take place in two hospital sites of the Paris University hospital (A Béclère and Kremlin-Bicètre).

NCT ID: NCT03019939 Completed - Clinical trials for Acute Myeloid Leukemia

Isavuconazole in Preventing Invasive Fungal Infections in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome and Neutropenia

Start date: March 28, 2017
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well isavuconazole works in preventing invasive fungal infections in adult patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome and neutropenia. Isavuconazole may help to prevent invasive fungal infections in adult patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome and neutropenia.

NCT ID: NCT02956967 Completed - Clinical trials for Non-Interventional Study

Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia

Start date: September 23, 2015
Phase:
Study type: Observational

Non-interventional, non-comparative, national, multi-site, single-arm prospective observational study to investigate home administration of Nivestim in the primary prophylaxis of chemotherapy-Induced febrile neutropenia

NCT ID: NCT02953340 Completed - Breast Cancer Clinical Trials

SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide

Start date: May 10, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) as measured by the duration of severe neutropenia (DSN).

NCT ID: NCT02912117 Completed - Infection Clinical Trials

Determining the Etiology of Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay

Start date: August 2016
Phase:
Study type: Observational

Prospective, observational study at Stanford University Hospital comparing the Karius Infectious Disease Diagnostic Sequencing Assay to the Final Microbiologic Diagnosis in Patients with Fever and Neutropenia.