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Last Updated: November 30, 2020

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CLINICAL TRIALS PROFILE FOR TBO-FILGRASTIM

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Biosimilar Clinical Trials for tbo-filgrastim

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT01542944 TevaGastrim for Stem Cell Mobilization Sibling Donors Completed Sheba Medical Center Phase 2 2012-02-01 The aim of this study is to evaluate the efficacy of TevaGastrim which is a biosimilar version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells from normal sibling donors for allogeneic stem cell transplantation.
NCT02098109 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 Completed Washington University School of Medicine Phase 2 2014-08-01 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.
NCT02806791 Efficacy of Biosimilar Filgrastim on the Mobilization of Hematopoietic Stem Cell CD34+ (Cluster of Differentiation 34) and on the Kinetic Engraftment Active, not recruiting Azienda Ospedaliera San Giovanni Battista N/A 2016-05-01 The endogenous growth factor granulocyte (G-CSF) stimulates the proliferation and differentiation of hematopoietic progenitors commissioned to mature as neutrophils and activated granulocytes mature neutrophils. In the field of hematology oncology G-CSF it is used to reduce the duration and complications of chemotherapy-induced neutropenia and to stimulate the mobilization and subsequent collection of circulating hematopoietic stem cells in order to use them for autologous transplantation procedure. Filgrastim and Lenograstim originator are marketed for many years and are considered the reference molecules for the production of biosimilar. For several years it is available and entered into common clinical practice the use of filgrastim biosimilar (Bio-GCSF) in treating the patient oncohematologic. Aim of the study is to analyze retrospectively a large series of patients and assess the impacts of the Bio-GCSF on the collection of hematopoietic stem cells and recovery of blood counts post autologous transplantation; the data will be compared with a historical cohort of reference that has been treated with G-CSF originator. The study results will not generate any diagnostic or therapeutic intervention in patients still alive.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for tbo-filgrastim

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000626 Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease Completed Amgen Phase 2 1969-12-31 Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease. Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
NCT00000626 Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease. Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
NCT00000801 Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To estimate the response rate, overall and disease-free survival, toxicities, factors associated with outcome, and effect on quality of life in patients with AIDS-related primary CNS lymphoma treated with CHOD (cyclophosphamide, doxorubicin, vincristine, and dexamethasone) plus filgrastim (granulocyte-colony stimulating factor; G-CSF) and external beam irradiation. To determine other clinical markers present in this patient population. Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for tbo-filgrastim

Condition Name

Condition Name for tbo-filgrastim
Intervention Trials
Lymphoma 214
Leukemia 193
Breast Cancer 81
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Condition MeSH

Condition MeSH for tbo-filgrastim
Intervention Trials
Lymphoma 277
Leukemia 257
Multiple Myeloma 113
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Clinical Trial Locations for tbo-filgrastim

Trials by Country

Trials by Country for tbo-filgrastim
Location Trials
United Kingdom 62
Switzerland 52
Sweden 9
Portugal 9
Czech Republic 8
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Trials by US State

Trials by US State for tbo-filgrastim
Location Trials
New York 268
Texas 263
California 259
Illinois 217
Ohio 206
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Clinical Trial Progress for tbo-filgrastim

Clinical Trial Phase

Clinical Trial Phase for tbo-filgrastim
Clinical Trial Phase Trials
Phase 4 13
Phase 3 161
Phase 2/Phase 3 16
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Clinical Trial Status

Clinical Trial Status for tbo-filgrastim
Clinical Trial Phase Trials
Completed 546
Recruiting 136
Active, not recruiting 119
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Clinical Trial Sponsors for tbo-filgrastim

Sponsor Name

Sponsor Name for tbo-filgrastim
Sponsor Trials
National Cancer Institute (NCI) 537
M.D. Anderson Cancer Center 115
Children's Oncology Group 70
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Sponsor Type

Sponsor Type for tbo-filgrastim
Sponsor Trials
Other 1131
NIH 574
Industry 193
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