NCT00806767已完成2 期
Phase II Study of Allogeneic Transplant of Hematopoietic Stem Cells From a Compatible Family Donor in the Treatment of Patients Over 55 Years With Hematological Malignancies
Institut Paoli-Calmettes2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2007年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Allogeneic hematopoietic stem cell transplant-related mortality
研究概览
简要总结
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 cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antilymphocyte globulin before transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well fludarabine, busulfan, and antilymphocyte globulin together with donor stem cell transplant works in treating older patients with hematological cancer.
详细描述
OBJECTIVES:
Primary
- To assess non-relapse or progression-related mortality at 1 year in patients over 55 with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation from a matched related, filgrastim (G-CSF)-mobilized donor and treated with conditioning comprising fludarabine phosphate, busulfan, and anti-lymphocyte globulin.
- To assess the incidence of graft-versus-host disease in these patients.
- To assess the incidence of relapse in these patients.
- To assess cellular recovery in these patients.
- To assess myeloid and lymphocyte chimerism in these patients.
Secondary
- To study the usual clinical and biological aspects of the transplantation in these patients.
- To study the impact of the Charlson score and the suitability for allogeneic transplantation score on mortality and 1-year survival.
- To assess the quality of life (QLQ-C30) of these patients.
- To study the economic cost of transplantation from conditioning to 1 year post-transplant.
- To study the mobilization and collection of progenitor stem cells in the donors.
- To study the psychological impact of donating stem cells on the donors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 56 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of a hematological malignancy
- •Candidate for an allogeneic hematopoietic stem cell transplantation
- •Available HLA-identical related donor
- •PATIENT CHARACTERISTICS:
- •WHO performance status (PS) 0-1 OR Karnofsky PS 70-100%
- •Life expectancy > 6 months
- •LVEF ≥ 40%
- •DLCO ≥ 50%
- •Creatinine clearance ≥ 30 mL/min
- •Transaminases and/or bilirubin ≤ 2 times upper limit of normal (ULN)
- •No other cancer within the past 5 years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •No human T-cell leukemia virus type 1 positivity
- •No HIV positivity
- •No uncontrolled bacterial, viral, or fungal infection
- •No contraindications to the study drugs
- •No concurrent serious and uncontrolled disease
- •PRIOR CONCURRENT THERAPY:
- •At least 1 month since prior participation in a clinical trial
排除标准
- 未提供
结局指标
主要结局
Allogeneic hematopoietic stem cell transplant-related mortality
次要结局
未报告次要终点
研究者
研究点 (2)
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