NCT00670423已完成1 期
A Phase I Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation
Jennifer E. Schwartz2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2008年5月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- To evaluate the maximum tolerated dose (MTD) of bortezomib in combination with tacrolimus and sirolimus as GVHD prophylaxis in patients undergoing myeloablative allogeneic peripheral blood stem cell transplantation.
研究概览
简要总结
The purpose of this study is determine the highest dose of bortezomib, a new drug for graft-versus host disease prevention, that can be given in combination with sirolimus and Tacrolimus, without causing severe side effects. This research is being done because there is no treatment that is 100% effective in preventing graft versus host disease.
The goals of this study are to:
- Collect peripheral blood stem cells (PBSCs) from donors for transplant.
- Determine the largest possible dose of bortezomib that can be given to recipients with various blood cancers in a safe manner.
- Monitor the recipient for risk of infection or side affects associated with the transplant.
- Monitor the recipient for increased immunity following transplantation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing myeloablative peripheral blood stem cell transplantation
- •Have an HLA matched-related or matched-unrelated donor (9/10 antigen or allelic mismatch or 10/10 HLA match permitted).
- •Hematological malignancy including patients with: AML, ALL, NHL, Hodgkin's Disease, CLL, CML, MDS and Multiple Myeloma
- •Meeting institutional standard criteria for allogeneic PBSC transplantation
排除标准
- •Patient has >Grade 2 peripheral neuropathy within 14 days before enrollment.
- •History of autologous or allogeneic transplantation
- •Evidence of HIV seropositivity
- •Evidence of active infection
- •Patients with cardiac dysfunction as described in the protocol
- •Patients with hypersensitivity to bortezomib, boron or mannitol
结局指标
主要结局
To evaluate the maximum tolerated dose (MTD) of bortezomib in combination with tacrolimus and sirolimus as GVHD prophylaxis in patients undergoing myeloablative allogeneic peripheral blood stem cell transplantation.
时间窗: Baseline through end of study
次要结局
- To describe engraftment(Baseline through end of study)
- To describe the incidence of acute and chronic GVHD(Baseline through end of study)
- To assess the toxicity of bortezomib(Baseline through end of study)
研究者
Jennifer E. Schwartz
Assistant Professor of Clinical Medicine
Indiana University
研究点 (2)
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