NCT01186224已完成不适用
A Comparison of Plerixafor/G-CSF with Chemotherapy/G-CSF for Stem Cell Mobilisation
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- A composite primary endpoint of BOTH an adequate stem cell harvest (≥4 x 106 CD34+/kg in no more than 2 aphereses); AND a neutrophil count that never falls below 1.0 x 109 / Litre in the 3 weeks following initiation of mobilisation.
研究概览
简要总结
To assess the efficacy and toxicity of plerixafor (AMD 3100) together with granulocyte-colony stimulating factor (G-CSF) for stem cell mobilisation, in patients with myeloma or lymphoma requiring high dose chemotherapy with stem cell rescue.
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
- •All of the following must be satisfied:
- •Aged 18 or over
- •Able to give informed written consent.
- •Diagnosis of EITHER multiple myeloma or related plasma cell dyscrasia, OR any form of lymphoma or associated lymphoproliferative disease Autologous stem cell transplantation is planned as the next course of treatment.
- •The patient has not previously undergone a mobilisation attempt for the current transplant. Patients who have received previous autologous transplants at least 2 years previously are eligible, as long as stem cell mobilisation has not been attempted for the current transplant.
- •No serious concomitant illness (e.g. heart disease) that might preclude completion of the study.
- •Creatinine clearance of at least 30 mls/min. Note that a dose reduction of plerixafor is required where the creatinine clearance is between 30-50 mls/min; see section 3.3/5.1/5.
- •Negative pregnancy test in women of childbearing age.
排除标准
- •Unable to give informed written consent
- •Pregnancy or lactating
- •Creatinine clearance of less than 30 mls/min. Patients with clearances lower than this may still be able to receive plerixafor at reduced dosage following discussion with the trial co-ordinators, but are not eligible for entry into this trial.
- •Any previous attempt at mobilisation for the current transplant. Patients with any form of leukaemia, INCLUDING PLASMA CELL LEUKAEMIA, are not eligible.
研究组 & 干预措施
Plerixafor plus G-CSF for patients undergoing stem cell harvesting
Experimental
Single arm comparison of plerixafor plus G-CSF for patients undergoing stem cell harvesting
干预措施: Plerixafor and G-CSF (Drug)
结局指标
主要结局
A composite primary endpoint of BOTH an adequate stem cell harvest (≥4 x 106 CD34+/kg in no more than 2 aphereses); AND a neutrophil count that never falls below 1.0 x 109 / Litre in the 3 weeks following initiation of mobilisation.
时间窗: 3 weeks following initiation of mobilisation
次要结局
- Serial neutrophil and platelet counts during mobilisation(1 Day)
- The time to platelet engraftment after subsequent transplantation(First of two consecutive days on which the platelet count equals or exceeds 50 x 109/litre, having been free of platelet transfusion for at least 48 hours)
- Total stem cell yield in 1-2 aphereses(1 day)
- The usage of plerixafor and the number and timing of apheresis collections(1 day)
- The time to neutrophil engraftment after subsequent transplantation(First of 2 consecutive days on which the neutrophil count equals or exceeds 0.5 x 109/litre)
研究者
研究点 (1)
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