Low Dose Plerixafor Plus G-CSF Efficiency in Mobilizing Stem Cells From Lymphoma and Myeloma Patients for Autologous Peripheral Blood Transplantation
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Harvest of of at least 2 x106 CD34+/kg
研究概览
简要总结
Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell mobilization. We want to demonstrate that half of the commonly prescribed dose can be safely administered once as a single dose in first attempt leading to apheresis yields of >2 x 106 CD34+ cells/kg body weight.
详细描述
Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell mobilization. Consecutive patients in autologous transplant protocol will receive mobilization consisted of daily subcutaneously G-CSF 10 mg/kg for 4 days and plerixafor 0.12 mg/kg as a single dose 11 hours prior to initiation of apheresis. HSC collection was performed with a Cobe Spectra® or Spectra Optia® apheresis system. The planned target blood volume to be processed will be 4-fold total blood volume calculated according to patients' weight and size. Peripheral blood CD34+ counts will be analyzed using flow cytometry. For each ASCT, we aimed for target yields of at least 2 x 106 CD34+cells/kg. Toxicities and engraftment will be documented.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates planned for an autologous haematopoietic stem cell transplantation without previous mobilization attempts with chemotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •WBC count ≥2.5x109/L.
- •Absolute neutrophil count ≥1.5x109/L.
- •Platelet count ≥100x109/L
排除标准
- •Prior allogeneic or autologous transplantation.
- •Pregnant women.
- •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.
- •Positive serology for hepatitis B or C or HIV.
- •Left ventricular ejection fraction < 40%
- •AST ALT >2.5x or Creatinine >2 md/dL
研究组 & 干预措施
Arm 1
Plerixafor 0.12 mg/kg SC will be administered in the evening, 11 hours prior to initiation of apheresis. G-CSF will be administered in the morning at 10 mcg/kg SC for 4 days prior to apheresis.
干预措施: Plerixafor 0.12 mg/kg (Drug)
结局指标
主要结局
Harvest of of at least 2 x106 CD34+/kg
时间窗: 5 days
percentage of patients with a target yields of at least 2 x 106 CD34+ cells/kg in one single aphaeresis procedure.
次要结局
- Rate of patients reaching a peripheral blood precount higher than 20 cells/μL(5 days)
- Time to engraftment(100 days)
研究者
David Gomez Almaguer
Hematology division chief
Hospital Universitario Dr. Jose E. Gonzalez