Clinical trials: Granulocyte Colony-Stimulating Factor
Carcinoma, Non-Small-Cell Lung
Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer
This study will test an investigational vaccine, called DRibbles, for the treatment of non-small cell lung cancer (NSCLC). We hypothesize that vaccination with the DRibble vaccine will cause an immune responses against proteins…
- Trial name
- NCT01909752
- Testing
- Cyclophosphamide, DRibble vaccine, Imiquimod
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- UbiVac
NSCLC, Neutropenia
A Study of Pegylated rhG-CSF as Support to Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy Receiving Chemotherapy
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy.
- Conditions
- NSCLC, Neutropenia, Febrile Neutropenia
- Trial name
- NCT01560195
- Testing
- Pegylated rhG-CSF: 100µg/kg, Pegylated rhG-CSF: 6mg
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Sarcoma, Neutropenia
Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy
Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced.
- Trial name
- NCT00035620
- Testing
- pegfilgrastim, filgrastim
- Volunteers
- 44 people
- Sponsor
- Amgen
Chemotherapy-induced Neutropenia
Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).
- Trial name
- NCT02104830
- Testing
- Empegfilrastim 6 mg, Filgrastim, Empegfilrastim 7.5 mg
- Where
- 13 sites in Russia
- Volunteers
- 135 people
- Sponsor
- Biocad
Neutropenia in Breast Cancer
A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer
This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.
- Trial name
- NCT01079676
- Testing
- Filgrastim (Eurofarma), Filgrastim (Granulokine, Amgen)
- Where
- 6 sites in Brazil
- Volunteers
- 220 people
- Sponsor
- Eurofarma Laboratorios S.A.
Non-Hodgkin's Lymphoma
Treatment for Subjects With Non-Hodgkin's Lymphoma
This multicenter, open-label, randomized, parallel study was designed to evaluate whether a single fixed-dose subcutaneous (SC) administration of pegfilgrastim or daily administration of Filgrastim for absolute neutrophil count…
- Trial name
- NCT00117897
- Testing
- pegfilgrastim, Filgrastim
- Sponsor
- Amgen
HIV Infections, Cytopenias
An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
To determine the safety, immunogenicity, biological activity, ad pharmacokinetics of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human granulocyte-macrophage colony-stimulating factor …
- Trial name
- NCT00002008
- Testing
- Sargramostim
- Where
- 2 sites in United States
- Sponsor
- Sandoz
Healthy Volunteers
A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.
This study compares the potential immunogenicity of two filgrastims, the proposed biosimilar Filgrastim Hospira (US) and the US-approved Neupogen reference product.
- Trial name
- NCT02923791
- Testing
- Filgrastim Hospira, US-Approved Neupogen
- Where
- 3 sites in United States
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hematopoietic Stem Cell Mobilization
Non-interventional, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Stem Cell Donors
Data collection on the safety and efficacy of Zarzio® / Filgrastim HEXAL® in adult healthy unrelated stem cell donors undergoing peripheral blood progenitor cell mobilization.
- Trial name
- SMART (NCT01766934)
- Where
- 2 sites in Germany
- Volunteers
- 245 people, healthy volunteers welcome
- Sponsor
- Sandoz
Neutropenic Complications, Breast Neoplasms
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®
The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
- Conditions
- Neutropenic Complications, Breast Neoplasms, Chemotherapy-induced Neutropenia, Chemotherapeutic Toxicity
- Trial name
- PROTECT-1 (NCT01735175)
- Testing
- LA-EP2006, Neulasta®
- Where
- 41 sites in Brazil, India and 4 more
- Volunteers
- 316 people
- Sponsor
- Sandoz
COVID-19
A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)
Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS)…
- Trial name
- NCT04351243
- Testing
- Gimsilumab
- Where
- 33 sites in United States
- Volunteers
- 227 people
- Sponsor
- Kinevant Sciences GmbH
Neuroblastoma
ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma
The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics [UTC] or the National Cancer Institute [NCI]).
- Trial name
- NCT01592045
- Testing
- ch14.18 -NCI, ch14.18-UTC, Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
- Where
- 13 sites in United States
- Volunteers
- 28 people
- Sponsor
- United Therapeutics
Arthritis, Rheumatoid
Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Challenge Study on Healthy Subjects
This exploratory study aims to assess exposure of healthy subjects to systemic challenge with either LPS or GM-CSF. This will be done by measuring inflammatory mediators and cellular activation markers both in circulation and in…
- Trial name
- NCT03306589
- Testing
- Cantharidin, Lipopolysaccharide, Granulocyte-Macrophage Colony-Stimulating Factor
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neuroblastoma Recurrent
Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma
An International, Single-Arm, Multicenter Phase 2 Trial.
- Trial name
- NCT04560166
- Testing
- Naxitamab and GM-CSF in combination with irinotecan and temozolomide
- Where
- 3 sites in Hong Kong, South Korea
- Volunteers
- 2 people
- Sponsor
- Y-mAbs Therapeutics
Leucocytosis
Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®
BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety of single-injection of Leucostim® to healthy volunteers compared to Neupogen®
- Trial name
- NCT02762799
- Testing
- Leucostim®, Neupogen®
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Biocad
Normal PBPC Donors
Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors
The purpose of this study is to clinically evaluate the spleen during PBPC mobilization by filgrastim in normal donors.
- Trial name
- NCT00115128
- Testing
- filgrastim
- Volunteers
- 309 people
- Sponsor
- Amgen
Neutropenia (Low White Blood Cell Count)
A Research Study To Test How Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given By Subcutaneous Injection (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)
This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds of white blood cells (WBC) known as…
- Trial name
- NCT02766647
- Testing
- Filgrastim Hospira (US), US-approved Neupogen®
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter
Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or…
- Trial name
- NCT00005958
- Testing
- filgrastim, docetaxel, gemcitabine hydrochloride
- Where
- 12 sites in United States
- Sponsor
- Amgen
Crohn Disease
Open-label Trial of Leukine in Active Crohn's Disease
The purpose of this study is to establish a safety profile sargramostim administered in 8 week cycles to adult patients with active Crohn's disease.
- Trial name
- NCT00206700
- Testing
- Sargramostim (Leukine)
- Where
- 167 sites in United States, Argentina and 8 more
- Volunteers
- 378 people
- Sponsor
- Genzyme, a Sanofi Company
Chemotherapy-induced Neutropenia, Cancer, Breast
Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients
The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast cancer patients with different doses and multiple injections.
- Trial name
- NCT03246009
- Testing
- rHSA/GCSF
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Tianjin SinoBiotech Ltd.