NCT01164345已完成2 期
Plerixafor (Plerixafor AMD 3100) + Recombinant Human G-CSF (rhG-CSF) for Autologous Peripheral Blood Stem Cell Transplantation (AutoSCT) in Hard to Mobilise Patients: a Phase IIB Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mobilisation success rate
研究概览
简要总结
The aim of this study is to evaluate Plerixafor (MOZOBIL) plus recombinant human G-CSF (G-CSF) efficiency in mobilizing sufficient number of stem cells from Lymphoma (NHL and HL) patients for autologous 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible and planned for an autologous haematopoietic stem cell transplantation.
- •1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •1.2 WBC count ≥2.5x109/L.
- •1.3 Absolute neutrophil count ≥1.5x109/L.
- •1.4 Platelet count ≥100x109/L
- •1.5 Adequate cardiac, renal, hepatic and pulmonary function sufficient to undergo apheresis and transplantation.
- •1.6 Previously, heavily pretreated lymphoma patients or patients suspected to have a poor bone marrow stem cell reserve for at least one of the following:
- •>2 lines of chemotherapy.
- •Previous radiotherapy involving bone marrow
- •Prior therapy with specific stem cell toxic chemotherapeutic agents
- •Platelets count pre-mobilisation, ≤150.103 x mm3
- •Level of circulating CD34+ ≤ 20 cells/mcL prior to apheresis on the collection day
- •Patients > 60 years of age
排除标准
- •2.1 Lymphoma patients that did not fulfil the inclusion criteria.
- •2.2 History of any acute or chronic leukemia (including myelodysplastic syndrome.
- •2.3 Prior allogeneic or autologous transplantation.
- •2.4 Inability to tolerate stem cell harvest.
- •2.5 Peripheral venous access not possible.
- •2.6 Pregnant or nursing women.
- •2.7 Positive serology for hepatitis B or C.
- •2.8 Acute infection (febrile, i.e. temperature > 38C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of GCSF.
- •2.9 HIV positive.
- •2.10 Left ventricular ejection fraction < 50%.
- •2.11 DLCO < 50%.
- •2.12 Splenectomised or splenic irradiation.
- •2.13 Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study.
- •2.14 Treatment with other investigational drugs within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilisation phase.
研究组 & 干预措施
MOZOBIL
Experimental
treatment with mozobil for autologous stem cell collection
干预措施: Plerixafor (Drug)
结局指标
主要结局
Mobilisation success rate
时间窗: 4 weeks
Mobilisation success rate is defined as the mobilisation of a PBSC graft containing \>2x106 CD34+ cells/kg in ≤ 4 apheresis sessions. We will evaluate the time from chemotherapy to stem cell collection,number of collections required to reach \>2x106 CD34+ cells/kg, number of CD34+ cells collected and percentage of patients reaching \>5x10 CD34+ cells/kg in ≤ 4 apheresis sessions.
次要结局
- engraftment after transplantation(100 days)
研究者
研究点 (1)
Loading locations...
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