Dose-reduced Generic Plerixafor Efficacy of Autologous Hematopoietic Stem Cell Transplantation in Patients with Lymphoma and Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Post-RD plerixafor increase in CD34+/μL pre-count, final CD34+ cell yield and harvest
研究概览
简要总结
Generic plerixafor use at reduced-dose for mobilization on HSCT transplant
详细描述
The objective of this study is to demonstrate that the use of a low dose of the generic form of a drug called plerixafor is effective in increasing the amount of hematopoietic cells (stem cells) in your blood, which will then be collected for your transplant. Plerixafor is a very effective medicine that is already used for this purpose, however its high cost limits its use in all patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
The patient receive a subcutaenous application (placbe vs generic plerixafor)
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
- •Patients with lymphoma or multiple myeloma who are candidates for autoHSCT
- •Patients > 18 years old who signed our informed consent
- •Normal CBC count (Hb > 10, WBC 4.0-11.00, plt > 100,000)
排除标准
- •Patients with HIV, Hepatitis C, Hepatitis B diagnosis
- •Pregnant women
研究组 & 干预措施
Generic plerixafor
Use a reduced-dose of generic plerixafor (0.12 mcg/Kg)
干预措施: Celrixafor (Drug)
Placebo
Use of a subcutaenous application of saline solution
干预措施: Celrixafor (Drug)
结局指标
主要结局
Post-RD plerixafor increase in CD34+/μL pre-count, final CD34+ cell yield and harvest
时间窗: 1 year
The objective of this study is to demonstrate that the use of a low dose of the generic form of plerixafor is effective in increasing the amount of hematopoietic cells (stem cells).
次要结局
未报告次要终点
研究者
Cesar Homero Gutierrez-Aguirre
Principal Investigator
Hospital Universitario Dr. Jose E. Gonzalez