Etude Phase I/II d'immunothérapie Par protéine recWT1-A10+AS01B après Greffe allogénique de Cellules Souches
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- safety
研究概览
简要总结
Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, underwent allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after reduced-intensity conditioning regimen.
If WT1 expression is detectable on tumor cells, they will receive an immune therapy 60 days after allograft.
6 administrations every 2 weeks of the protein recwt1-A10+AS01B will be administrated.
The safety and immunological efficacy of this immune therapy after hematopoietic stem cells transplantation with reduced intensity conditioning will be evaluated.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 and younger than 65 years.
- •Karnofsky ≥ 70 %.
- •Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, who underwent allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after reduced-intensity conditioning regimen.
- •Patients in morphologic complete remission at the time of transplantation.
- •WT1 expression detectable on tumor cells.
- •Expected life duration more than 6 months.
- •Creatinine clearance ≥ 50 ml/min
- •Bilirubinemia < 1.5N and ASAT < 2.5N.
- •Women of childbearing age: negative pregnancy test and effective contraception for at least 30 days before vaccinal immunotherapy (the same contraceptive method must be continued at least 2 months after the last vaccine infusion).
- •Membership of a social security scheme or beneficiary of such a regime.
- •Signed inform consent.
排除标准
- •Patients with severe and uncontrolled affections, especially active graft-versus-host disease requiring steroid treatment (>0.3 mg/kg/j) and/or Mycophenolate mofetil.
- •Pregnant or lactating women.
- •HIV seropositive patients.
- •Autoimmune disease (Lupus, multiple sclerosis, Chron disease…)
- •Previous history of allergic state which could be potentially compound by a component of the vaccinal immunotherapy.
- •Patients who received (or are planned to receive) another experimental treatment within 30 days following the first infusion of the experimental drug of this protocol.
- •Previous history of another cancer, except if considered as probably cured by the investigator.
- •Patients deprived of liberty, or under guardianship.
研究组 & 干预措施
immune therapy
6 administration every 2 weeks of intra-muscular 200 micrograms of protein recwt1-A10+AS01B at week 1, 3, 5, 7, 9 and 11.
干预措施: recwt1-A10+AS01B (Biological)
结局指标
主要结局
safety
时间窗: 30 days
Dose limit toxicity (adverse event according to CTCAE V4.0)
次要结局
- immune response(up to 60 weeks after treatment)