NCT00996359终止1 期
Partially HLA-Matched Irradiated Allogeneic Cellular Therapy After Reduced Intensity Total Body Irradiation
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Toxicity
研究概览
简要总结
RATIONALE: Giving low-dose total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).
PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant after total-body irradiation and to see how well it works in treating patients with relapsed or refractory hematologic cancer or acute myeloid leukemia or acute lymphocytic leukemia in complete remission.
详细描述
OBJECTIVES:
Primary
- To evaluate the toxicity of irradiated haploidentical allogeneic cellular therapy after low-dose total-body irradiation and no pharmacologic graft-vs-host disease prophylaxis in patients with relapsed or refractory hematologic malignancies or patients with acute myeloid leukemia (AML) or acute lymphoblastic leukemia in second or greater complete remission (CR2).
Secondary
- To evaluate immunologic parameters before and after haploidentical therapy.
- To demonstrate host anti-leukemia T-cells in a subset of patients with AML who are HLA-A2-positive.
- To observe any evidence of antitumor activity within the confines of this pilot study and/or assess the duration of remission in those patients who enter the study in CR2.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Patients over 18 years old must meet the following criteria:
- •Histologically confirmed hematologic malignancy and not a candidate for a standard allogeneic transplantation
- •High-risk disease, including:
- •Refractory/relapsed acute myeloid leukemia (AML) or AML in second or greater completion remission (CR2)
- •Relapsed or refractory acute lymphoblastic leukemia (ALL) or ALL in CR2
- •Tyrosine kinase inhibitor-resistant chronic myelogenous leukemia in chronic, accelerated, or blast crisis
- •Fludarabine-resistant chronic lymphocytic leukemia
- •High-risk myelodysplastic syndrome (MDS) (i.e., MDS with a score ≥ 1.5 by the International Scoring System)
- •Chronic myelomonocytic leukemia
- •Relapsed diffuse large cell non-Hodgkin lymphoma (NHL) with measurable disease after (or not eligible for) high-dose chemotherapy/autologous hematopoietic stem cell (HSC) rescue or allogeneic hematopoietic stem cell transplantation (HSCT)
- •Relapsed follicular NHL, mantle cell lymphoma, or low-grade histology NHL with measurable disease after (or not eligible for) high-dose chemotherapy/autologous HSC rescue or allogeneic HSCT
- •Relapsed or refractory high-grade/aggressive NHL (Burkitt lymphoma, lymphoblastic lymphoma, T-cell lymphoma, NK-like lymphoma) with measurable disease after (or not eligible for) high-dose chemotherapy/autologous HSC rescue or allogeneic HSCT
- •Hodgkin lymphoma with measurable disease after (or not eligible for) high-dose chemotherapy/autologous HSC rescue or allogeneic HSCT
- •Relapsed or refractory multiple myeloma after (or not eligible for) high-dose chemotherapy/autologous HSC rescue and following salvage therapy with thalidomide, lenalidomide, bortezomib or other FDA-approved multiple myeloma salvage therapies
- •Patients 13-17 years old must meet the following criteria:
- •Histologically confirmed hematologic malignancy and not a candidate for a standard allogeneic transplantation
- •High-risk disease, including:
- •Refractory/relapsed AML or AML in CR2
- •Relapsed or refractory ALL or ALL in CR2
- •Relapsed diffuse large cell NHL with measurable disease after (or not eligible for) high-dose chemotherapy/autologous HSC rescue or allogeneic HSCT
- •Relapsed follicular NHL, mantle cell lymphoma (or low-grade histology NHL) with measurable disease after (or not eligible for) high-dose chemotherapy/autologous HSC rescue or allogeneic HSCT
- •Relapsed or refractory high-grade/aggressive NHL (Burkitt lymphoma, lymphoblastic lymphoma, T-cell lymphoma, NK-like lymphoma) with measurable disease after (or not eligible for) high-dose chemotherapy/autologous HSC rescue or allogeneic HSCT
- •Hodgkin lymphoma with measurable disease after (or not eligible for) high-dose chemotherapy/autologous HSC rescue or allogeneic HSCT
- •Eligible for haploidentical irradiated cellular therapy
- •No known active brain metastases or malignant meningitis
- •Available partially (≥ 3/6 class I antigen) HLA-matched (by serology) related donor NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-2
- •Karnofsky PS 60-100% (for patients > 16 years) or Lansky PS 60-100% (for patients ≤ 16 years)
- •Patients who are unable to walk because of paralysis but who are up in a wheelchair will be considered ambulatory for the purpose of assessing PS
- •Patients ≥ 18 years:
- •Total bilirubin < 1.5 times upper limit of normal (ULN) (unless attributable to Gilbert disease)
- •DLCO/alveolar volume > 50%
- •Serum creatinine < 2.0 mg/dL
- •Patients 13-17 years:
- •Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
- •13 to < 16 years: 1.5 mg/dL (male) or 1.4 mg/dL (female)
- •≥ 16 years: 1.7 mg/dL (male) or 1.4 mg/dL (female)
- •AST/ALT ≤ 2.5 times ULN for age
- •Total bilirubin < 2.0 mg/dL (unless attributable to Gilbert syndrome)
- •Shortening fraction ≥ 27% by ECHO or ejection fraction ≥ 50% by radionuclide angiogram
- •FEV_1, forced vital capacity, and DLCO corrected for hemoglobin ≥ 60% by pulmonary function tests (PFTs)
- •Children unable to cooperate for PFTs must meet the following criteria:
- •No evidence of dyspnea at rest
- •No exercise intolerance
- •No requirement for supplemental oxygen therapy
- •Any other organ dysfunction thought to be secondary to disease will be considered separately and the patient will be eligible at the physician's discretion
- •Not pregnant or nursing
- •Negative pregnancy test
- 另有 8 项未显示
排除标准
- 未提供
研究组 & 干预措施
Irradiated allogeneic lymphocytes after Total Body Irradiation
Experimental
干预措施: Irradiated haploidentical allogeneic lymphocytes (Biological)
Irradiated allogeneic lymphocytes after Total Body Irradiation
Experimental
干预措施: total-body irradiation (Radiation)
结局指标
主要结局
Toxicity
时间窗: 3 years
次要结局
- Immunologic parameters before and after haploidentical therapy(3 years)
- Anti-tumor activity and/or duration of remission in those patients who enter the study in second complete remission or greater(3 years)
- Treatment-related mortality(3 years)
研究者
研究点 (1)
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