^
    3ms
    Continuous Versus Bolus Administration of G-CSF in Children With Cancer (clinicaltrials.gov)
    P4, N=20, Active, not recruiting, Chang Gung Memorial Hospital | Recruiting --> Active, not recruiting | N=40 --> 20
    Enrollment closed • Enrollment change
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    Granocyte (lenograstim) • Neupogen (filgrastim)
    10ms
    EMEG-ECDD: Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration (clinicaltrials.gov)
    P=N/A, N=100, Recruiting, Centre Georges Francois Leclerc | Trial completion date: Apr 2024 --> Oct 2025 | Trial primary completion date: Apr 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
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    cyclophosphamide • epirubicin • Neulasta (pegfilgrastim) • Granocyte (lenograstim) • Neupogen (filgrastim)
    1year
    Continuous Versus Bolus Administration of G-CSF in Children With Cancer (clinicaltrials.gov)
    P4, N=40, Recruiting, Chang Gung Memorial Hospital
    New P4 trial
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    Granocyte (lenograstim) • Neupogen (filgrastim)
    1year
    Genetic Engineering of Hematopoietic Progenitor Stem Cells for Targeted IFN-α Immunotherapy Reprogramming the Solid Tumor Microenvironment: A First-in-Man Study in Glioblastoma Multiforme (NCT03866109) (ASH 2023)
    Autologous CD34+ HSPC are mobilized with lenograstim and plerixafor, collected by apheresis, purified and ex vivo modified with a lentiviral vector. So far, up to 3 million Temferon cells/kg have been co-administered with a fixed dose of non-manipulated CD34+ supporter cells following a sub-myeloablative conditioning regimen (Thiotepa + BCNU or Busulfan or Busulfan alone)... These data show that Temferon is safe and biologically active at the tumor site and favors anti-tumor immunity. The results provide initial evidence of Temferon's potential to modulate the TME of GBM patients and to counteract disease progression and improve the survival of uMGMT GBM patients.
    IO biomarker
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    MGMT (6-O-methylguanine-DNA methyltransferase) • CD8 (cluster of differentiation 8) • CD34 (CD34 molecule) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • IFNA1 (Interferon Alpha 1)
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    thiotepa • busulfan • Granocyte (lenograstim) • Temferon (Autologous CD34+ enriched HSPCs expressing interferon-alpha 2) • plerixafor
    1year
    CARDIOSTEM: Donation of Whole Blood by Healthy Volunteers After Mobilisation by Haematopoietic Growth Factor (Rhu-G-CSF = Granocyte) (clinicaltrials.gov)
    P1, N=40, Recruiting, CellProthera | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    CD34 (CD34 molecule)
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    Granocyte (lenograstim)
    1year
    EMEG-ECDD: Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration (clinicaltrials.gov)
    P=N/A, N=100, Recruiting, Centre Georges Francois Leclerc | Not yet recruiting --> Recruiting | Trial completion date: Apr 2023 --> Apr 2024 | Trial primary completion date: Apr 2023 --> Apr 2024
    Enrollment open • Trial completion date • Trial primary completion date
    |
    cyclophosphamide • epirubicin • Neulasta (pegfilgrastim) • Granocyte (lenograstim) • Neupogen (filgrastim)
    over1year
    Mobilization of hematopoietic stem cells with lenograstim in multiple myeloma patients: Prospective multicenter observational study (KMM122). (PubMed, Cancer Med)
    Lenograstim can safely and effectively mobilize stem cells in MM autologous settings.
    Observational data • Journal
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    CD34 (CD34 molecule)
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    Granocyte (lenograstim) • Neupogen (filgrastim)
    over1year
    A Phase II Study Evaluating Intravenous Melphalan With Autologous Whole Blood Stem Cell Transplantation Over Three Cycles In Patients With Castration-Resistant Prostate Cancer (MEL-CAP) (clinicaltrials.gov)
    P2/3, N=29, Terminated, Barts & The London NHS Trust | Unknown status --> Terminated; Early termination
    Trial termination
    |
    melphalan • Granocyte (lenograstim)
    2years
    The Effects of Plerixafor on Hemostatic System in Patients Undergoing Stem Cell Mobilization (TCT-ASTCT-CIBMTR 2023)
    Lenograstim was used in 46.7% of the patients, and filgrastim in 53.3%. The findings of our study showed that G-CSF has activated the hemostatic system as expected and as a novel finding, the addition of plerixafor to G-CSF in poor mobilizers did not exert further significant procoagulant effects and did not cause alterations in endothelial damage markers
    Clinical
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    CXCL12 (C-X-C Motif Chemokine Ligand 12)
    |
    Granocyte (lenograstim) • Neupogen (filgrastim) • plerixafor
    2years
    Reprogramming Macrophages Using Autologous Hematopoietic Stem Cells As Immunotherapy for Glioblastoma: TEM-GBM Study (NCT03866109) (ASH 2022)
    Autologous CD34+ HSPC are mobilized with lenograstim and plerixafor, collected by apheresis, purified and ex vivo modified with a lentiviral vector that enables HSC TEMs progeny to be loaded with IFN-a. So far, up to 3 million Temferon cells/kg have been co-administered with a fixed dose of non-manipulated CD34+ supporter cells following a sub-myeloablative conditioning regimen (Thiotepa + BCNU/Busulfan)... Our interim results show that Temferon is well tolerated, with no dose limiting toxicities identified to date. The results provide initial evidence of Temferon's potential to modulate the TME of GBM patients, and anecdotal evidence for long lasting effects of Temferon in prevention of disease progression.
    IO biomarker
    |
    CD34 (CD34 molecule) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • NFKB1 (Nuclear factor of kappa light polypeptide gene enhancer in B-cells 1) • IFNA1 (Interferon Alpha 1)
    |
    thiotepa • busulfan • Granocyte (lenograstim) • Temferon (Autologous CD34+ enriched HSPCs expressing interferon-alpha 2) • plerixafor