Matched Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplantation With a Conditioning Regimen of Targeted Busulfan, Cyclophosphamide, and Thymoglobulin

University of Nebraska1 个研究点分布在 1 个国家目标入组 5 人开始时间: 2005年6月7日最近更新: 2023年10月23日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: University of Nebraska
入组人数: 5
试验地点: 1
主要终点: Transplantation-related Mortality at 100 Days Post-transplantation

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 chemotherapy before a donor bone marrow transplant or peripheral stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide and antithymocyte globulin followed by donor stem cell transplant works in treating patients with hematologic cancer.

详细描述

OBJECTIVES:

Primary

To determine the incidence of grade II-IV acute graft-versus-host disease in patients with hematologic cancer or other diseases treated with a myeloablative conditioning regimen comprising targeted (steady-state concentration of 800-1,000 ng/mL) busulfan, cyclophosphamide, and anti-thymocyte globulin followed by matched unrelated donor allogeneic hematopoietic stem cell transplantation.
To determine the day +100 transplantation-related mortality in these patients.

Secondary

To determine the effect of cyclophosphamide pharmacokinetic parameters on day +100 transplantation-related mortality in these patients.
To determine the ability of low-dose anti-thymocyte globulin administered on day +5 to induce activation-induced cell death of activated donor lymphocytes.
To determine the incidence of chronic graft-versus-host disease in patients treated with this regimen.
To determine event-free and overall survival of patients treated with this regimen.
To evaluate pharmacogenomic associations between genetic polymorphisms in drug disposition enzymes with the pharmacokinetics of busulfan and cyclophosphamide.

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: 19 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Pathologically confirmed diagnosis of 1 of the following:
•Acute myeloid leukemia
•Acute lymphocytic leukemia
•Chronic myelogenous leukemia beyond first chronic phase (i.e., 2nd chronic phase, accelerated phase, or blast crisis)
•Multiple myeloma
•Myelodysplastic syndromes
•Malignant lymphoma
•Myelofibrosis
•Requirement for myeloablative conditioning regimen confirmed by attending physician
•Available donor must meet the following criteria:
•HLA phenotypically identical unrelated donor by low, intermediate, or high resolution for HLA class I antigens, and by high resolution for HLA class II antigens
•Matched at the A, B, and DRβ1 loci
•Single HLA-A or HLA-B antigen mismatch allowed
•Meets all National Marrow Donor Program or foreign registry criteria for allogeneic bone marrow/stem cell donors
•Peripheral blood stem cells are the preferred product on this study but bone marrow is allowed
•Karnofsky performance status 70-100%
•DLCO ≥ 50% predicted
•LVEF ≥ 45%
•Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 65 mL/min
•Serum total bilirubin ≤ 2.0 mg/dL
•Fertile patients must use effective contraception

排除标准

•No active uncontrolled infection
•Not pregnant or nursing/negative pregnancy test
•No HIV infection
•No chronic active hepatitis B or C or evidence of cirrhosis on liver biopsy