Clinical trials: Granulocyte Colony-Stimulating Factor
Melanoma
Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma
The objective of this study is to evaluate the efficacy and safety of treatment with talimogene laherparepvec compared to subcutaneously administered GM-CSF in patients with unresectable Stage IIIb, IIIc and Stage IV melanoma.
- Trial name
- NCT00769704
- Testing
- Talimogene laherparepvec, GM-CSF
- Where
- 83 sites in United States, Canada and 2 more
- Volunteers
- 437 people
- Sponsor
- BioVex Limited
Chemotherapy-induced Neutropenia
Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer
The purpose of the present trial is to evaluate the safety, tolerability and pharmacokinetics(PK)/pharmacodynamics(PD) of single subcutaneous injection of GW003 in breast cancer patients.
- Trial name
- NCT02725606
- Testing
- Pegylated Recombinant Human G-CSF, GW003
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Jiangsu T-Mab Biopharma Co.,Ltd
Infertility
Diafert for Embryo Selection and Fertility Improvement (DESTINy)
Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.
- Trial name
- DESTINy (NCT02593513)
- Testing
- Daifert, Control Group
- Where
- Hungary
- Volunteers
- 108 people
- Sponsor
- Forest Laboratories
Breast Neoplasms, Chemotherapy-Induced Febrile Neutropenia
Efficacy and Safety Study With MYL-1401H and Neulasta
This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy.
- Trial name
- NCT02467868
- Testing
- MYL-1401H, Neulasta
- Where
- 36 sites in Bulgaria, Georgia and 4 more
- Volunteers
- 193 people
- Sponsor
- Mylan Inc.
Infertility
Diafert® for Embryo Selection and Fertility Improvement
Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.
- Trial name
- DESTINy (NCT02593461)
- Testing
- Daifert, Control Group
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Forest Laboratories
Non-Hodgkin's Lymphoma
A Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim in Subjects With Non-Hodgkin's Lymphoma
The purpose of this study is to evaluate the ability of two different fixed doses of pegfilgrastim (6mg and 12mg) and a by-weight dose of filgrastim (5ug/kg/day) for the mobilisation and collection of PBPCs for autologous…
- Trial name
- NCT00117455
- Testing
- pegfilgrastim, filgrastim
- Sponsor
- Amgen
Relapsed/Refractory Large B-cell Lymphoma
Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma
The primary objectives of this study are: Phase 1: To evaluate the safety of sequenced therapy with lenzilumab and axicabtagene ciloleucel in participants with relapsed or refractory large B-cell lymphoma and identify the most…
- Trial name
- ZUMA-19 (NCT04314843)
- Testing
- Cyclophosphamide, Fludarabine, Lenzilumab
- Where
- 10 sites in United States
- Volunteers
- 6 people
- Sponsor
- Kite, A Gilead Company
Healthy Adult Subjects
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects
TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine whether TJ003234 is safe and tolerated when…
- Trial name
- NCT03794180
- Testing
- TJ003234
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- I-Mab Biopharma US Limited
Lung Cancer
Docetaxel and Vinorelbine Plus Filgrastim in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
- Trial name
- NCT00006215
- Testing
- filgrastim, docetaxel, vinorelbine tartrate
- Where
- 19 sites in United States
- Sponsor
- Amgen
HIV Infections, Cytopenias
A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
To determine the maximum tolerated dose (MTD) and toxicity of sargramostim (recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF) given by continuous intravenous infusion (CIV) in patients with leukopenia in…
- Trial name
- NCT00002009
- Testing
- Sargramostim
- Where
- 2 sites in United States
- Sponsor
- Sandoz
Lymphoma, Leukemia
Evaluate the Efficacy and Safety of the Prophylactic Use of PEG-rhG-CSF in Children With Hematological Malignancies
The incidence of infectious complications in hematological malignancies is higher than that in children with solid tumors, which may be related to the type and dose intensity of chemotherapy regimens used in hematological tumors.
- Trial name
- NCT04497701
- Testing
- PEG-rhG-CSF group, rhG-CSF group
- Where
- China
- Volunteers
- 139 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Multiple Myeloma
Plerixafor Plus Granulocyte Colony-stimulating Factor (G-CSF) For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Multiple Myeloma
Primary Objective: To determine if Multi Myeloma (MM) patients mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 6 x 10^6…
- Trial name
- NCT02221479
- Testing
- plerixafor GZ316455, Filgrastim
- Where
- 5 sites in Japan
- Volunteers
- 14 people
- Sponsor
- Genzyme, a Sanofi Company
Chemotherapy-induced Neutropenia
Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients
Evaluation of the efficacy and safety of recombinant human serum albumin / granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced neutropenia
- Trial name
- NCT03251768
- Testing
- rHSA-GCSF 2.4mg, GCSF
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Tianjin SinoBiotech Ltd.
Healthy
Biosimilarity Study of Subcutaneous Filgrastim in Healthy Volunteers
This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between filgrastim formulation, produced by Megalabs (test product) and Granulokine® (reference product)…
- Trial name
- NCT04958772
- Testing
- Filgrastim Megalabs, Granulokine
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Megalabs
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Clofarabine, Cytarabine, and Filgrastim Followed by Infusion of Non-HLA Matched Ex Vivo Expanded Cord Blood Progenitors in Treating Patients With Acute Myeloid Leukemia
This phase I trial is studying the safety and potential efficacy of infusing non-human leukocyte antigen (HLA) matched ex vivo expanded cord blood progenitors following treatment with clofarabine and cytarabine for patients with…
- Conditions
- Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b)
- Trial name
- NCT01031368
- Testing
- cytarabine, clofarabine, filgrastim
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Nohla Therapeutics, Inc.
Febrile Neutropenia, Cancer
Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor
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…
- Conditions
- Febrile Neutropenia, Cancer, Breast Cancer, Ovarian Cancer
- Trial name
- Monitor-GCSF (NCT01459653)
- Where
- 117 sites in Austria, Belgium and 10 more
- Volunteers
- 1,496 people
- Sponsor
- Sandoz
Cytomegalovirus Retinitis, HIV Infections
Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute…
- Trial name
- NCT00002070
- Testing
- Sargramostim, Ganciclovir
- Where
- 14 sites in United States
- Sponsor
- Schering-Plough
Neuroblastoma
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response.
This is a single-arm, multicenter clinical trial conducted in patients ≥ 12 months of age with high-risk neuroblastoma in first complete response.
- Trial name
- NCT06047535
- Testing
- Naxitamab
- Volunteers
- 62 people
- Sponsor
- SciClone Pharmaceuticals
Soft Tissue Sarcoma, Sarcoma
A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma
The purpose of the study is to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which neutropenia (low white blood cell counts) could be managed with filgrastim (a Granulocyte-Colony Stimulation…
- Conditions
- Soft Tissue Sarcoma, Sarcoma, Neoplasms, Connective and Soft Tissue, Neoplasms by Histologic Type
- Trial name
- NCT00102609
- Testing
- Doxorubicin, Trabectedin, Dexamethasone
- Volunteers
- 41 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Hematopoietic Stem Cell Transplantation
NOX-A12 Multiple Ascending Dose Study in Healthy Volunteers
This is the second clinical study of NOX-A12. This study intends to provide information on the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeated intravenous doses of NOX-A12 (2.0 and 4.0 mg/kg/d)…
- Trial name
- SNOXA12C101 (NCT01194934)
- Testing
- NOX-A12, Filgrastim, NOX-A12 in combination with Filgrastim
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- TME Pharma AG