A follow-up study evaluating the long term safety of autologous CD34+-enriched hematopoietic progenitor cells genetically modified with a lentiviral vector encoding for the human interferon-α2 gene previously administered to patients with glioblastoma multiforme

Glioblastoma multiforme (GBM)

The primary endpoint is to assess the mutagenic potential of Temferon following administration (the first two years of the monitoring are included in the TEM-GBM_001 study), as evaluated by the incidence of hematopoietic malignancies or potentially life threatening, malignant solid or other hematological tumors.

Safety: the incidence of increasingly expanding clone of peripheral white blood cells., Safety: Long-term tolerability and safety of Temferon following Temferon administration, evaluated by: - routine clinical and laboratory surveillance; - development or exacerbation of non-GBM related neurologic disorders attributed to Temferon exposure; - development or exacerbation of hematologic disorders, rheumatologic disorders, autoimmune manifestations attributed to Temferon exposure; - development of infections that are attributed to Temferon exposure., Efficacy: identify myeloid cells in peripheral blood (PB), Efficacy: determine the proportions of patients achieving complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) using standard iRANO criteria., Efficacy: Overall Survival (OS) will be calculated from the first day following Temferon administration.

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