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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
The primary objective is to evaluate the long term mutagenic safety of Temferon.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients who have received Temferon and completed the follow-up in the TEM-GBM_001 study.
- •Able and willing to provide written informed consent and comply with the study protocol and procedures.
排除标准
- •There are no exclusion criteria for this study
结局指标
主要结局
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.
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.
次要结局
- 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.
研究者
Genenta Science
Scientific
Genenta Science S.p.A.