Clinical trials: G-CSF
Chemotherapy-induced Neutropenia
Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
Determination of the effect of balugrastim on the duration and severity of severe neutropenia.
- Trial name
- NEUGR-002 (NCT00837265)
- Testing
- Balugrastim, Pegfilgrastim, Chemotherapy Regimen
- Volunteers
- 334 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Lymphoma, Non-Hodgkin
Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients
The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better than G-CSF alone to mobilize and collect the optimal…
- Trial name
- NCT00103610
- Testing
- Granulocyte colony-stimulating factor plus plerixafor
- Where
- 32 sites in United States, Canada
- Volunteers
- 298 people
- Sponsor
- Genzyme, a Sanofi Company
Severe Chronic Neutropenia
Immunogenicity, Safety, and Efficacy of Zarzio®/Filgrastim HEXAL® in Patients With Severe Chronic Neutropenia
Purpose of the study is to investigate the safety, immunogenicity and the efficacy of Zarzio®/Filgrastim HEXAL® under chronic administration for 12 months in patients diagnosed with severe chronic neutropenia.
- Trial name
- NCT01859637
- Testing
- Filgrastim
- Where
- 2 sites in Germany, Sweden
- Volunteers
- 6 people
- Sponsor
- Sandoz
Neutropenia
A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement
The purpose of the study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of daily subcutaneous administration of 5 μg/kg tbo-filgrastim in infants, children and adolescents with solid tumors without…
- Trial name
- NCT02190721
- Testing
- tbo-filgrastim
- Where
- 33 sites in United States, Bulgaria and 6 more
- Volunteers
- 50 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Chemotherapy-induced Neutropenia
Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.
- Trial name
- NCT01569087
- Testing
- empegfilrastim, filgrastim
- Where
- 5 sites in Russia
- Volunteers
- 60 people
- Sponsor
- Biocad
Multiple Myeloma, Lymphoma, Non-Hodgkin
AMD3100 (Plerixafor) Given to NHL and MM Patients to Increase the Number of PBSCs When Given a Mobilizing Regimen of G-CSF
This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with…
- Trial name
- NCT00396266
- Testing
- G-CSF Plus Plerixafor
- Where
- 2 sites in Canada
- Volunteers
- 22 people
- Sponsor
- Genzyme, a Sanofi Company
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
Chemotherapy-Induced Neutropenia
Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study
The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid…
- Trial name
- VISTA (NCT02454530)
- Testing
- Nivestim®
- Where
- 92 sites in France
- Volunteers
- 1,160 people
- Sponsor
- Pfizer
Breast Cancer
Immunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer
The purpose of this study is to compare the immunogenicity of Peg-filgrastim versus Neulasta® as an adjunct to chemotherapy in patients with breast cancer
- Trial name
- NCT03511378
- Testing
- Lupin's Pegfilgrastim, Neulasta®
- Where
- 17 sites in India
- Volunteers
- 138 people
- Sponsor
- Lupin Ltd.
Lymphoma, Non-Hodgkin, Multiple Myeloma
Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients
Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100).
- Trial name
- NCT00322387
- Testing
- G-CSF and plerixafor
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Genzyme, a Sanofi Company
Stage IV (Metastatic) Breast Cancer
A Phase I/II Study of ABI-007 (Abraxane®, Nab®-Paclitaxel)and Vinorelbine in Patients With Stage IV (Metastatic) Breast Cancer
The purpose of this study is to: 1) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the absence of planned growth factor support with granulocyte colony-stimulating factor…
- Trial name
- NCT00140140
- Testing
- ABI-007, vinorelbine, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Celgene
Lymphoma, Non-Hodgkin, Multiple Myeloma
Mobilization of Stem Cells With AMD3100 (Plerixafor) and G-CSF in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients
This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with…
- Trial name
- NCT00322491
- Testing
- G-CSF Plus Plerixafor
- Where
- 8 sites in United States
- Volunteers
- 49 people
- Sponsor
- Genzyme, a Sanofi Company
Multiple Myeloma
A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma (MM)
A total of 122 subjects were randomized into the study and investigated in the double-blind placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF + placebo.
- Trial name
- GENESIS (NCT03246529)
- Testing
- BL-8040 1.25 mg/kg + G-CSF
- Where
- 18 sites in United States, Germany and 3 more
- Volunteers
- 180 people
- Sponsor
- BioLineRx, Ltd.
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
Multiple Myeloma, Non-Hodgkin Lymphoma
PD and Safety of TG-0054 Combined With G-CSF in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients
This is a phase II study to evaluate the efficacy and safety of TG-0054 combined with G-CSF in mobilizing hematopoietic stem cells in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin disease.
- Conditions
- Multiple Myeloma, Non-Hodgkin Lymphoma, Hodgkin Disease
- Trial name
- NCT02104427
- Testing
- TG-0054 combined with G-CSF
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- GPCR Therapeutics, Inc.
Non-Hodgkin's Lymphoma
Evaluation of Approved Weight-Based Dose Compared to Fixed Dose of Plerixafor in Patients With Non-Hodgkin's Lymphoma (NHL) Weighing Less Than 70 Kilograms
The purpose of this study was to compare the responses of 2 different doses of plerixafor in patients with Non-Hodgkin's Lymphoma (NHL) who received an autologous stem cell transplant.
- Trial name
- NCT01164475
- Testing
- Granulocyte-colony stimulating factor (G-CSF), Fixed Dose Plerixafor, Weight-Based Plerixafor
- Where
- 7 sites in United States, Canada and 2 more
- Volunteers
- 61 people
- Sponsor
- Genzyme, a Sanofi Company
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
Chemotherapy Associated Neutropenia, Breast Cancer
Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim
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.
- Trial name
- PIONEER (NCT01519700)
- Testing
- EP2006, Filgrastim
- Where
- 26 sites in Czechia, Hungary and 4 more
- Volunteers
- 218 people
- Sponsor
- Sandoz
Healthy Participants
Study of the Effect of a 5-Day Regimen of Study Drug on Peripheral Stem Cell Mobilization in Healthy Participants
A multi-center, open-label, single-arm clinical study to assess effects of a 5-day regimen of 10 micrograms per kilogram (mcg/kg) of tbo-filgrastim administered subcutaneously daily on the mobilization of cluster of…
- Trial name
- GRANIX (NCT03029000)
- Testing
- Tbo-filgrastim
- Where
- 9 sites in United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Multiple Myeloma, Lymphoma, Non-Hodgkin's
AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone
This Phase 2 study was designed to assess the safety and hematological activity of AMD3100 (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2*10^6…
- Trial name
- NCT00395967
- Testing
- G-CSF plus plerixafor
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Genzyme, a Sanofi Company