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Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic Anemia

2014年1月3日 更新者:University of California, San Francisco

Non-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic Anemia

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, 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 system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.

PURPOSE: This clinical trial is studying how well a donor stem cell transplant works in treating patients with hematologic cancer, metastatic kidney cancer, or aplastic anemia.

研究概览

详细说明

OBJECTIVES:

Primary

  • Determine the treatment-related mortality (TRM) rate at 100 days in patients with hematologic malignancy, metastatic renal cell carcinoma, or aplastic anemia undergoing nonmyeloablative allogeneic stem cell transplantation using matched unrelated donors.

Secondary

  • Determine the TRM at 12 months in patients treated with this regimen.
  • Determine the 6-month engraftment rate in patients treated with this regimen.
  • Determine 1-year overall survival of patients treated with this regimen.

OUTLINE:

  • Nonmyeloablative preparative regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3, busulfan* IV over 6 hours on days -4 and -3, and anti-thymocyte globulin IV over 6-10 hours on days -4 to -1.

NOTE: *Patients with aplastic anemia receive cyclophosphamide IV over 2 hours on days -6 to -3 instead of busulfan.

  • Allogeneic stem cell reinfusion: Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover.
  • Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus orally twice daily or IV continuously beginning on day -2 and continuing for approximately for 6-12 months after transplantation. Patients also receive mycophenolate mofetil orally or IV twice daily on days 0 to 60 and methotrexate IV on days 1, 3, 6, and 11**.

NOTE: **Patients with aplastic anemia receive methotrexate IV on days 1, 3, and 6 (not day 11).

  • Donor lymphocyte infusion (DLI): After day 180, patients with no evidence of active GVHD may receive DLI. A second DLI may be infused > 8 weeks after the first in the absence of disease response or GVHD.

After completion of study treatment, patients are followed periodically for at least 2 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

研究类型

介入性

注册 (预期的)

35

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • San Francisco、California、美国、94115
        • UCSF Comprehensive Cancer Center
    • North Carolina
      • Winston-Salem、North Carolina、美国、27157-1096
        • Wake Forest University Comprehensive Cancer Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 74年 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • Aplastic anemia not responsive to immunosuppressive therapy
    • Metastatic renal cell carcinoma
    • Hematologic malignancy, including any of the following:

      • Acute myeloid leukemia (AML)* not curable with chemotherapy and meeting any of the following criteria:

        • AML with high-risk cytogenetic abnormalities (e.g., -7, -7q, -5, -5q, complex, Philadelphia chromosome-positive [Ph+])
        • AML evolved from prior myelodysplasia
        • AML secondary to prior chemotherapy
        • Failed to achieve remission
        • In second or subsequent remission NOTE: *Marrow blasts < 10%- can be achieved by chemotherapy
      • Myelodysplasia* with any of the following high-risk features:

        • Adverse cytogenetics (-7, 7q, -5, -5q, complex)
        • Excess blasts
        • Prior conversion to AML
        • Severe cytopenias with absolute neutrophil count < 500/mm^3 or platelet count < 20,000/mm^3 NOTE: *Marrow blasts < 10%- can be achieved by chemotherapy
      • Acute lymphoblastic leukemia (ALL)* not curable with chemotherapy and meeting any of the following criteria:

        • High-risk cytogenetics (Ph+, 11q23 abnormalities, monosomy 7)
        • More than 1 induction course required to achieve remission
        • Failed to enter remission
        • In second or subsequent remission NOTE: *Marrow blasts < 10 %
      • Chronic lymphocytic leukemia (CLL) with high-risk features, including any of the following:

        • Refractory to initial or subsequent therapy
        • Progression after initial response to therapy
        • Prolymphocytic morphology
      • Follicular lymphoma with any of the following high-risk features:

        • Refractory to initial or subsequent therapy
        • Progression after response to initial therapy
        • Has ≥ 3 International Prognostic Index (IPI) risk factors
      • Multiple myeloma

        • Stage II-III disease confirmed at diagnosis or after initial progression
      • Other lymphoma that has failed to respond to primary therapy, progressed, or recurred after prior therapy, including any of the following:

        • Diffuse large cell lymphoma
        • Mantle cell lymphoma
        • Hodgkin's lymphoma
      • Myeloproliferative disease with evidence of disease acceleration, including any of the following:

        • Myelofibrosis
        • Polycythemia vera
        • Essential thrombocythemia
      • Chronic myeloid leukemia (CML) that failed to be controlled by imatinib mesylate
  • Disease must be stable or responding to therapy
  • No rapid progression of malignant disease

    • Expected time to disease progression > 12 weeks
  • Not eligible for autologous stem cell transplantation
  • Matched unrelated donor available

    • 9/10 HLA matched, including HLA-A, -B, -C, -DR, and -DQ

PATIENT CHARACTERISTICS:

  • Creatinine < 2.0 mg/dL
  • Creatinine clearance > 40 mL/min
  • Bilirubin < 3 mg/dL

    • Elevated total bilirubin due to Gilbert's disease allowed if direct bilirubin is normal
  • AST < 4 times upper limit of normal
  • Hepatitis C or B allowed provided bilirubin and AST are normal
  • Cardiac ejection fraction > 30%
  • DLCO > 40% of predicted
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled active infection requiring ongoing antibiotic treatment
  • No poor performance status
  • No poor organ function

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior stem cell or bone marrow transplantation allowed

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 屏蔽:无(打开标签)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Charles A. Linker, MD、University of California, San Francisco

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年5月1日

研究注册日期

首次提交

2006年2月23日

首先提交符合 QC 标准的

2006年2月23日

首次发布 (估计)

2006年2月24日

研究记录更新

最后更新发布 (估计)

2014年1月6日

上次提交的符合 QC 标准的更新

2014年1月3日

最后验证

2007年4月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • CDR0000463522
  • UCSF-01251
  • UCSF-H5010-19585-05
  • UCSF-2101

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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