NCT00162513撤回1 期
Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Investigate the feasibility of allogeneic tumor cell vaccine for patients with resistant CML.
研究概览
简要总结
Donors with CM will be solicited from a waiting list of patients awaiting BMT from the waiting list of MUD searches.
Maximally matched donor will be searched for each eligible CML patient with a goal in mind to find other patients with CML that share both class I and class II determinants. Sharing of one class I II will be considered eligible for participation in the study. Peripheral blood and PBMC from the donors will be isolated, washed and irradiated.
The cells will be injected into the consenting patients intracutaneously at 2 weeks intervals for a total of 6 injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above the age of 55 consenting to participate in the study.
- •Patients with documented CML with Philadelphia chromosome t (9:21)
- •Patients with no HLA matched sibling.
- •Patients eligible for BMT for who no matched unrelated donor can be identified after completion of an international donor search lasting for more than six months, or patients that have failed BMT.
- •Patients with contra-indication to BMT.
- •Patients refusing BMT.
- •Patients who failed interferon alpha, ARAc and/or Glivec.
排除标准
- •Patients requiring immunosuppressive therapy or corticosteroids.
结局指标
主要结局
Investigate the feasibility of allogeneic tumor cell vaccine for patients with resistant CML.
次要结局
- To induce immunity against a putative bcr/abl peptide bound to MHC identical class I, II or preferably both.
研究者
研究点 (2)
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