Clinical trials: Pegfilgrastim
Healthy Volunteers
Pharmacokinetic / Pharmacodynamic Study Comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta
This is a single center, double-blind, randomized, comparative pharmacokinetic and pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy Volunteers.
- Trial name
- NCT02479646
- Testing
- MYL-1401H, EU-Neulasta, US-Neulasta
- Where
- Netherlands
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- Mylan Inc.
Alcoholic Hepatitis
Pegfilgrastim in Patients With Alcoholic Hepatitis
This is a multi-center, prospective, randomized trial of standard of care vs. standard of care + pegfilgrastim (Neulasta®) among patients with a clinical diagnosis of alcoholic hepatitis and DF≥32.
- Trial name
- NCT02776059
- Testing
- Standard of care + pegfiltrastim, Standard of care
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Timothy Morgan, MD
Lymphoma
Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread.
- Trial name
- NCT00101010
- Testing
- Filgrastim, Pegfilgrastim, Rituximab
- Where
- 7 sites in United States
- Volunteers
- 80 people
- Sponsor
- M.D. Anderson Cancer Center
Relapsed Neuroblastoma, Metastatic Pheochromocytoma
131I-Metaiodobenzylguanidine (131I-MIBG) Therapy for Relapsed/Refractory Neuroblastoma
This expanded access is the best available therapy/compassionate use designed to determine the palliative benefit and toxicity of 131I-MIBG in patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma who are…
- Trial name
- NCT03649438
- Testing
- 131 I-Metaiodobenzylguanidine, Potassium Iodide, G-csf
- Where
- United States
- Sponsor
- University of Texas Southwestern Medical Center
Sarcoma
Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die.
- Trial name
- NCT00061984
- Testing
- pegfilgrastim, doxorubicin hydrochloride, ifosfamide
- Where
- 41 sites in Austria, Belgium and 9 more
- Volunteers
- 455 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Diabetes Mellitus, Type 1
ATG-GCSF in New Onset Type 1 Diabetes
This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte colony-stimulating factor (ATG-GCSF), at least 28 subjects…
- Trial name
- ATG-GCSF (NCT02215200)
- Testing
- Anti-Thymocyte Globulin (ATG), Granulocyte colony stimulating factor (GCSF)
- Where
- 13 sites in United States
- Volunteers
- 89 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leukemia, Lymphoma
Pentostatin, Cyclophosphamide, Rituximab, and Mitoxantrone in Treating Patients With Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Cancer
RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and mitoxantrone, work in different ways to stop the growth…
- Trial name
- NCT00546377
- Testing
- filgrastim, pegfilgrastim, rituximab
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Immunogenicity, Healthy Volunteers
Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; Intas Pharmaceuticals Ltd.
- Trial name
- NCT04015232
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
Resected Pancreatic Adenocarcinoma
Study of Proton Therapy in Adjuvant Pancreatic Cancer
This trial aims to determine a safe schedule of short-course proton beam radiation therapy with adjuvant mFOLFIRINOX for patients with resected pancreatic adenocarcinoma.
- Trial name
- Proton-PANC (NCT03885284)
- Testing
- mFOLFIRINOX, Proton beam radiation
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Georgetown University
Multiple Myeloma
Bendamustine, Lenalidomide (Revlimid®) and Dexamethasone (BRd) as 2nd-line Therapy for Patients With Relapsed or Refractory Multiple Myeloma
Almost all patients with multiple myeloma who survive initial treatment will eventually relapse and require further therapy. Background: Treatment with lenalidomide and dexamethasone has proven efficacy in two large randomized…
- Trial name
- BRd (NCT01701076)
- Testing
- Bendamustine
- Where
- Switzerland
- Volunteers
- 50 people
- Sponsor
- Cantonal Hospital of St. Gallen
Unresectable Locally Advanced NSCLC
Combined Modality Therapy With Growth Factor Support in Locally Advanced Non-small Cell Lung Cancer (NSCLC)
To determine the safety and efficacy of administering filgrastim with concurrent chemoradiotherapy and the potential benefit of administering pegfilgrastim with consolidation chemotherapy in patients with unresectable locally…
- Trial name
- NCT00682383
- Testing
- Cisplatin; Etoposide; Radiation therapy; Docetaxel; Neulasta
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Mt. Sinai Medical Center, Miami
Multiple Myeloma
Phase 1-2 Amrubicin in Combo With Lenalidomide + Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma
To assess if amrubicin is safe and useful for patients with multiple myeloma requiring additional treatment.
- Trial name
- NCT01355705
- Testing
- Amrubicin, Lenalidomide, Dexamethasone
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Michaela Liedtke
Breast Cancer
Trial to Compare the Efficacy and Safety of Pegfilgrastim Biosimilar in Subjects With High Risk Stage Breast Cancer Receiving Chemotherapy
This is a Phase III, randomised, assessor-blind, parallel group, multicentre trial. At least 180 adult subjects with high-risk Stage II or Stage III / IV breast cancer will be randomised (1:1) to receive either Eurofarma's…
- Trial name
- NCT02768714
- Testing
- Eurofarma's pegfilgrastim, Neulastim
- Sponsor
- Eurofarma Laboratorios S.A.
Multiple Myeloma, Lymphoma, Non-Hodgkin
Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
This study will compare the results of stem cell mobilization using drugs called filgrastim (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02 filgrastim (Granix) and plerixafor.
- Trial name
- NCT02098109
- Testing
- XM02 Filgrastim, Filgrastim, Apheresis
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Washington University School of Medicine
Chemotherapy-induced Neutropenia
Randomized Phase 2, Dose-finding Efficacy, Safety Study of ANF-RHO™ Versus Neulasta® in Chemotherapy-Induced Neutropenia
Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing…
- Trial name
- NCT03559387
- Testing
- ANF-RHO™, Neulasta®
- Where
- 8 sites in France, Netherlands
- Volunteers
- 9 people
- Sponsor
- Prolong Pharmaceuticals
Metastatic Castration-resistant Prostate Cancer
Phase I Cabazitaxel, Mitoxantrone, and Prednisone Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to test the safety of cabazitaxel, mitoxantrone, and prednisone (CAMP) in combination at different dose levels and to determine the highest dose that does not cause bad side effects.
- Trial name
- NCT01594918
- Testing
- Cabazitaxel, Mitoxantrone, Prednisone
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Rahul Aggarwal
Breast Cancer
Dose-dense Doxorubicin/Cyclophosphamide With Intermittent Low-dose Sunitinib in Breast Cancer Patients
Background: The investigators previously studied the addition of low-dose, short-course sunitinib to pre-operative chemotherapy in the neoadjuvant setting in newly diagnosed breast cancer patients with measurable primary breast…
- Trial name
- NCT02790580
- Testing
- Dose-dense doxorubicin/cyclophosphamide + sunitinib, Dose-dense doxorubicin/cyclophosphamide
- Where
- Singapore
- Volunteers
- 98 people
- Sponsor
- National University Hospital, Singapore
Bone Pain in Stage I - III Breast Cancer
NOLAN: Naproxen or Loratadine and Neulasta
The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic…
- Trial name
- NOLAN (NCT01712009)
- Testing
- Naproxen, Loratadine, Pegfilgrastim
- Where
- 83 sites in United States
- Volunteers
- 600 people
- Sponsor
- Amgen
Osteosarcoma, Lung Metastases
A Study of Pre-Operative Treatment of Newly-Diagnosed, Surgically-Resectable Osteosarcoma With Doxorubicin, Ifosfamide, Etoposide, and Cisplatin With Early Metabolic Assessment of Response
This is a pilot study that will allow investigators to collect data related to early and potentially more accurate response assessments using a chemotherapy protocol that eliminates methotrexate to maximize the dose intensity of…
- Trial name
- NCT01258634
- Testing
- Dexrazoxane, Doxorubicin, Cisplatin
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Chicago
Grade 3b Follicular Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma
Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Relapsed Grade 3b Follicular Lymphoma
This phase I trial studies the best dose of copanlisib when given together with combination chemotherapy (R-GCD) in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to…
- Conditions
- Grade 3b Follicular Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Follicular Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
- Trial name
- NCT04156828
- Testing
- Copanlisib, Gemcitabine, Carboplatin
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Washington