NCT00333190已完成不适用
CD8+ T Cell Depletion as Graft Versus Host Disease Prophylaxis After HLA-Matched Unrelated Donor Non-myeloablative Peripheral Blood Stem Cell Transplantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- To assess the initial engraftment of HLA matched unrelated donor mobilized peripheral blood stem cells depleted of CD+8 cells.
研究概览
简要总结
The purpose of this trial is to determine if selectively removing only a small subset of T cells, called CD8+ T cells, is safe and if it can reduce the risk of graft versus host disease (GVHD) without losing the anti-cancer effects.
详细描述
- The patient will be admitted to the hospital once a good donor is found for chemotherapy and stem cell transplant. The patient will remain in the hospital for 8 days and will receive two chemotherapy drugs (fludarabine and Busulfex) intravenously once each day for 4 days.
- On the third day after the patient has finished chemotherapy, the donor cells should arrive at Dana-Farber Cancer Institute and the lab will remove CD8 cells. Then the product will be given to the patient through a central line. If there are not enough stem cells in the donor product, then the CD8 cells will not be taken out, and the patient will get the whole product.
- Just before and after the transplant, the patient will also take tacrolimus and methotrexate to help prevent GVHD. Tacrolimus is a pill that will be taken orally two times a day. Methotrexate is a chemotherapy drug that is given intravenously on days 1, 3 and 6 after the transplant. In addition to the these drugs, participants will also take antibiotics to prevent infection and Filgrastim (G-CSF, neupogen) until their white blood cell counts are better.
- After the stem cell infusion, check-ups and blood tests will be performed at least once a week for 1 month. At about one month, a bone marrow biopsy to look for the donor's cells in the participants bone marrow will be performed. After the 1-month evaluation, the patient will be seen at least every 2 weeks with another bone marrow biopsy at 3-4 months after the transplant.
- After the patient is past 100 days since transplant, they will be followed in the clinic and have blood work done at least once a month until 6 months post transplant.
- The trial will end at 6 months after the transplant, but patients will be tracked for the rest of their life to look at long-term effects of this transplant.
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
- Prevention
- 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
- •Hematologic malignancies that are candidates for allogeneic non-myeloablative stem cell transplantation
- •AML or ALL in first or subsequent remission, or in resistant or untreated relapse with marrow blast < 20% of cellularity
- •CML in first or subsequent chronic phase, or accelerated phase
- •Myelodysplastic syndrome with < 20% marrow blasts
- •NHL or Hodgkin's lymphoma in second or greater remission, or partial remission after salvage therapy, and in patients with marrow involvement, <20% involvement in BM
- •CLL RAI stage 2-4, which has progressed after initial fludarabine containing therapy, and BM involvement of < 20%
- •Multiple myeloma stage II-III, in first or subsequent plateau phase with <20% BM plasma cells
- •Available unrelated donor who is fully HLA matched at HLA-A,B,C and DRB1
- •Age 18 or greater
- •Performance status 0-2
- •Life expectancy of > 100 days
- •No HLA-matched related donor available
排除标准
- •Myeloproliferative disorders other than CML
- •MDS with myeloproliferative features, or CMML
- •High grade Burkitts or Burkitts-like Non-Hodgkin's lymphoma
- •Prior allogeneic stem cell transplant
- •Active CNS involvement with disease
- •Uncontrolled infection
- •Pregnancy
- •Evidence of HIV infection
- •Heart failure uncontrolled my medications
- •Total bilirubin > 2.0 mg/dl that is due to hepatocellular dysfunction
- •AST > 2 x institutional upper limit of normal
- •Serum creatinine > 2.0 mg/dl
结局指标
主要结局
To assess the initial engraftment of HLA matched unrelated donor mobilized peripheral blood stem cells depleted of CD+8 cells.
时间窗: 2 years
次要结局
- to determine the incidence of GVHD(2 years)
- to assess disease relapse.(2 years)
- To assess sustained engraftment(2 years)
研究者
Vincent T. Ho, MD
Principal Investigator
Dana-Farber Cancer Institute
研究点 (4)
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