临床试验/NCT00448201

NCT00448201已完成2 期

Allogeneic Hematopoietic Cell Transplantation for Patients With Hematologic Disorders Who Are Ineligible or Inappropriate for Treatment With a More Intensive Therapeutic Regimen

UNC Lineberger Comprehensive Cancer Center1 个研究点分布在 1 个国家目标入组 71 人开始时间: 2011年1月7日最近更新: 2017年5月30日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: UNC Lineberger Comprehensive Cancer Center
入组人数: 71
试验地点: 1
主要终点: Treatment-related Mortality

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: Giving low doses of chemotherapy, such as busulfan and fludarabine, before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. It also helps stop 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 or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Immunosuppressive therapy may improve bone marrow function and may be an effective treatment for hematologic cancer or other disease.

PURPOSE: This clinical trial is studying the side effects and how well giving busulfan and fludarabine with or without antithymocyte globulin followed by donor stem cell transplant works in treating patients with hematologic cancer or other disease.

详细描述

OBJECTIVES:

Primary

Determine the clinical efficacy and toxicity profiles of a nonmyeloablative preparative regimen comprising busulfan and fludarabine with or without anti-thymocyte globulin followed by allogeneic hematopoietic stem cell transplantation in patients with hematologic cancers or other diseases.
Determine the feasibility of this regimen in these patients.
Establish a treatment-related mortality during the first 6 months that is less than 20% in patients treated with this regimen.

Secondary

Determine the response rates (disease-specific partial response and complete response) in patients treated with this regimen.
Determine overall and progression-free survival of patients treated with this regimen.
Determine the percent donor chimerism and immunologic recovery, including dendritic cell recovery, in patients treated with this regimen.
Determine the risk of acute and chronic graft-versus-host disease and other toxicities in patients treated with this regimen.
Assess the overall nonhematologic grades 3 and 4 toxicity of this regimen, including the incidence of veno-occlusive disease and pulmonary toxicity, in these patients.

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: 10 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

Methotrexate Only Arm

Active Comparator

GVHD Prophylaxis with Methotrexate

干预措施: sargramostim (Biological)

Methotrexate Only Arm

Active Comparator

GVHD Prophylaxis with Methotrexate

干预措施: therapeutic allogeneic lymphocytes (Biological)

Methotrexate Only Arm

Active Comparator

GVHD Prophylaxis with Methotrexate

干预措施: busulfan (Drug)

Methotrexate Only Arm

Active Comparator

GVHD Prophylaxis with Methotrexate

干预措施: fludarabine phosphate (Drug)

Methotrexate Only Arm

Active Comparator

GVHD Prophylaxis with Methotrexate

干预措施: methotrexate (Drug)

Methotrexate Only Arm

Active Comparator

GVHD Prophylaxis with Methotrexate

干预措施: tacrolimus (Drug)

Methotrexate Only Arm

Active Comparator

GVHD Prophylaxis with Methotrexate

干预措施: nonmyeloablative allogeneic hematopoietic stem cell transplantation (Procedure)

Methotrexate Only Arm

Active Comparator

GVHD Prophylaxis with Methotrexate

干预措施: peripheral blood stem cell transplantation (Procedure)