Phase 2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Recurrent Survivin-Expressing Diffuse Large B-Cell Lymphoma (DLBCL)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Objective response rate
研究概览
简要总结
This phase 2 study was designed to assess the efficacy and safety of DPX-Survivac plus low dose cyclophosphamide in up to 24 subjects with recurrent diffuse large B-cell lymphoma (DLBCL) who are not eligible for transplant. However, with the evolving field of immunotherapy Immunovaccine has begun to focus on combination therapies, combining DPX-Survivac treatment with checkpoint inhibitors and other immune modulators. This phase 2 study was therefore terminated with fewer subjects than planned to allow the progress of other studies, such as NCT03349450.
详细描述
A multi-center treatment study assessing the efficacy and safety of an immunotherapeutic vaccine (DPX-Survivac) combined with low dose cyclophosphamide. Subjects with measurable, histologically proven DLBCL expressing survivin will be treated in this open-label, single arm study. Survivin is a protein commonly over-expressed in many types of cancer, including DLBCL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with histologically proven recurrent DLBCL. Subjects may have recurrence after primary or second treatment regimens for DLBCL. Subjects with recurrence at least 90 days post-autologous stem cell transplantation (ASCT) are eligible. Patients with partial response or measurable disease after first line therapy (who are not candidates for ASCT) or after second line therapy without disease progression may also be eligible.
- •Previous localized surgery, radiotherapy, and chemotherapy more than 21 days prior to SD
- •Subjects may have received previous courses of an investigational biologic therapy including active or passive immunotherapy (e.g. rituximab), other B cell depleting antibody therapy, or radioimmunotherapy (e.g. tositumomab or ibritumomab) if last administration is greater than 77 days prior to SD
- •Subjects must have at least one measurable site of disease.
- •Willing to undergo a pre-treatment and post-treatment tumor biopsy.
- •Subjects must have evidence of survivin expression in pre-treatment tumor sample.
- •A screening Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-
- •A life expectancy > 6 months.
排除标准
- •Patients eligible for possible curative therapies such as ASCT.
- •Patients undergoing concurrent chemotherapy, radiation therapy, or immunotherapy or who are currently on an investigational product/trial are excluded. There must be at least 21 days since completion of prior chemotherapy/radiation and at least 77 days since completion of immunotherapy until study treatment begins (SD0). Subjects must have recovered from all acute toxicities from prior treatment; peripheral neuropathy must be < grade
- •Lactate dehydrogenase (LDH) greater than 2 times the upper limit of normal.
- •Patients with refractory disease after their last treatment (i.e. progression within 90 days).
- •Patients who have received prior survivin based vaccines.
- •Progressive CNS lymphoma requiring treatment within 84 days prior to SD
- •History of active autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis requiring treatment within the last two years.
研究组 & 干预措施
DPX-Survivac + low dose cyclophosphamide
干预措施: DPX-Survivac (Biological)
DPX-Survivac + low dose cyclophosphamide
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Objective response rate
时间窗: approximately 6 months
次要结局
- Immune response(1 year)
- Frequency of adverse events(1 year)