Phase 1-2 Study of a CpG-Activated Whole Cell Vaccine Followed by Autologous "Immunotransplant" for Mantle Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ronald Levy
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Freedom From Molecular Residual Disease (MRD) Post-autologous Stem Cell Transplant (ASCT)
研究概览
简要总结
Mantle cell lymphoma (MCL) is a sub-type of non-Hodgkin's lymphoma (NHL) which is generally considered incurable with current therapy. Participants will receive an autologous vaccine against their individual lymphoma after undergoing stem cell transplantation. This vaccination may prolong the time which patients will stay in remission from their disease.
详细描述
Study treatment is a complex set of steps of research procedures and regular medical care. By using a participant's cancer cells as an immungen, the study hopes to improve freedom from molecular residual disease (MRD).
PRIMARY OBJECTIVE Freedom from molecular residual disease at 1-year post-autologous transplant.
SECONDARY OBJECTIVE Time To Clinical Progression (TTP)
This study has 2 research agents, PF-03152676 and CpG-MCL Vaccine.
PF-03152676 is a synthetic DNA molecule, 24 nucleotides in length with a nuclease-resistant phosphorothioate backbone. It is an immunostimulatory, single-stranded oligodeoxynucleotide (oligo-DNA) containing unmethylated cytosine and guanine (CpG) motifs and synthesized with a nuclease-resistant phosphorothioate backbone. PF-03512676 acts as an agonist of human Toll-like receptor 9, leading to activation of antigen-presenting cells and a cascade of anti-tumor immune reactions.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CpG-MCL Vaccine
An autologous anti-tumor vaccine.
干预措施: Vaccine-primed T-cells (Procedure)
CpG-MCL Vaccine
An autologous anti-tumor vaccine.
干预措施: CpG-MCL vaccine (Biological)
CpG-MCL Vaccine
An autologous anti-tumor vaccine.
干预措施: PF-3512676 (Biological)
CpG-MCL Vaccine
An autologous anti-tumor vaccine.
干预措施: Autologous hematopoietic stem cell transplant (HSCT) (Procedure)
CpG-MCL Vaccine
An autologous anti-tumor vaccine.
干预措施: Rituximab (Drug)
CpG-MCL Vaccine
An autologous anti-tumor vaccine.
干预措施: Standard induction chemotherapy (Drug)
CpG-MCL Vaccine
An autologous anti-tumor vaccine.
干预措施: Cyclophosphamide (Drug)
CpG-MCL Vaccine
An autologous anti-tumor vaccine.
干预措施: Filgrastim (Drug)
结局指标
主要结局
Freedom From Molecular Residual Disease (MRD) Post-autologous Stem Cell Transplant (ASCT)
时间窗: 12 months
Molecular residual disease (MRD) is defined as detection in blood samples by the ClonoSEQ test of the (11;14) (q13;q32) gene translocation. It is considered positive if a tumor-specific VDJ sequence is detected in the peripheral blood cells by Ig-HTS at a frequency of greater or equal to 1 molecule per 10,000 input leukocyte equivalents of DNA within 1 year post-autologous stem cell transplant (ASCT). The outcome will be reported as number and percent of participants that maintain MRD-negative status (ie, 1-year freedom from MRD). This outcome is reported as a number without dispersion.
次要结局
- Time-to-progression (TTP)(7.7 years)
- Overall Survival (OS)(After 1, 2, 3, 4, and 5 years)
- Detection of Tumor-specific CD8-positve Memory T-cells Before and After Vaccination(Baseline and after vaccination and transplant, approximately 5 years)
- Detection of Tumor-specific CD4-positve T-cells Before and After Vaccination(Baseline and after vaccination and transplant, approximately 5 years)