NCT00054340已完成1 期
Conditioning With Targeted Busulfan, Cyclophosphamide and Thymoglobulin for Allogeneic Marrow or Peripheral Blood Stem Cell (PBSC) Transplantation for Myelodysplasia and Myeloproliferative Disorders
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Combining antithymocyte globulin with combination chemotherapy before donor peripheral stem cell transplantation may reduce the chance of developing graft-versus-host disease following transplantation.
PURPOSE: Phase I/II trial to study the effectiveness of combining antithymocyte globulin with busulfan and cyclophosphamide in reducing graft-versus-host disease in patients who are undergoing donor stem cell transplantation for myelodysplastic syndrome or other myeloproliferative disorder.
详细描述
OBJECTIVES:
- Determine the incidence of acute graft-vs-host disease (GVHD) requiring therapy in patients with myelodysplastic syndromes or myeloproliferative disorders treated with busulfan, cyclophosphamide, and anti-thymocyte globulin prior to transplantation with filgrastim (G-CSF)-mobilized peripheral blood stem cells (or bone marrow) from related or unrelated donors.
- Determine the incidence of relapse and relapse-free survival in patients treated with this regimen.
- Determine the incidence of non-relapse mortality by day 100 and 1 year posttransplantation in patients treated with this regimen.
- Determine the incidence of Epstein-Barr virus reactivation, infections, and chronic GVHD in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of anti-thymocyte globulin.
- Conditioning and graft-vs-host disease (GVHD) prophylaxis: Patients receive oral busulfan every 6 hours on days -7 to -4 (16 doses), cyclophosphamide IV on days -3 and -2, and anti-thymocyte globulin IV over 3 hours on days -3, -2, and -1.
Cohorts of 15 patients receive adjusted doses of anti-thymocyte globulin to determine the optimal dose at which Epstein-Barr virus (EBV) activation and GVHD are reduced. The optimal dose is the dose at which 2 consecutive cohorts receive the same regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following:
- •Myelodysplastic syndromes (including those that have evolved to acute myeloid leukemia)
- •Myeloproliferative disorders
- •No chronic myelogenous leukemia
- •Other diseases eligible for conditioning with targeted busulfan, cyclophosphamide, and anti-thymocyte globulin that are not candidates for other studies
- •Available related or unrelated donor compatible for HLA-A, -B, -C, DRB1, and DQB1
- •A single allele mismatch at HLA-A, -B, -C, or DRB1 is allowed
- •PATIENT CHARACTERISTICS:
- •65 and under
- •Performance status
- •Not specified
- •Life expectancy
- •No severe limitation due to other diseases
- •Hematopoietic
- •Not specified
- •AST no greater than 2 times normal
- •No hepatic disease
- •Creatinine no greater than 2 times upper limit of normal OR
- •Creatinine clearance at least 50% for age, gender, and weight
- •Cardiovascular
- •No cardiac insufficiency requiring treatment
- •No symptomatic coronary artery disease
- •No severe or mild hypoxemia
- •pO_2 at least 70 mm Hg and DLCO at least 70% of predicted OR
- •pO_2 at least 80 mm Hg and DLCO at least 60% of predicted
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No growth factors given posttransplantation concurrently with methotrexate immunosuppression
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
研究者
研究点 (2)
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