A Pilot Study of Combined Plerixafor + Filgrastim for Mobilization of Peripheral Blood Stem Cells From Normal Donors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Successful Collection of Stem Cells
研究概览
简要总结
RATIONALE: Giving chemotherapy and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they will help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving colony-stimulating factors, such as filgrastim (G-CSF) and plerixafor, to the donor helps the stem cells move (mobilization) from the bone marrow to the blood so they can be collected and stored.
PURPOSE: This clinical trial is studying giving plerixafor and filgrastim together for mobilization of donor peripheral blood stem cells before a peripheral blood stem cell transplant in treating patients with hematologic malignancies
详细描述
PRIMARY OBJECTIVES:
I. The percentage of normal donors who collect at least 2 x 10^6 CD34 cells/kg recipient weight on day 1 after administration of combined filgrastim and plerixafor.
SECONDARY OBJECTIVES:
I. Measuring CD34+ cells/ul in peripheral blood of donors 11, 15, 24 and 36 hours post dosing.
II. Tolerance and safety of combined filgrastim and Plerixafor in normal donors.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hematologic malignancy considered eligible and suitable for allogeneic stem cell transplantation (syngeneic transplantation is acceptable); diagnoses include acute myeloid or lymphoid leukemias, chronic myeloid or lymphoid leukemias, multiple myeloma, lymphoma or myelodysplasia; subjects suitable for this study will primarily receive transplant on a standard treatment plan (non research regimen)
- •Organ function, performance status and age suitable for an ablative regimen consisting of TBI >= 10Gy or a chemotherapy regimen consisting of busulphan and cyclophosphamide (BuCY) or busulphan and melphalan (BuMel)
- •Availability of a fully matched sibling donor
- •Ability to understand and willingness to sign an informed consent
- •No uncontrolled infections
- •DONOR: Human leukocyte antigen (HLA) identical sibling donor
- •DONOR: >= 18 years
- •DONOR: No unacceptable risk to donor due to pre-existing illness
- •DONOR: Must have suitable antecubital veins for leukapheresis venipuncture; donors who will require a temporary, Mahurkar-type catheter are not eligible
- •DONOR: Ability and willingness to sign an informed consent document
排除标准
- •Eligible for and willingness to participate in any research study of transplant regimens
- •Eligible for and willingness to participate in a non ablative transplant regimen
- •Human immunodeficiency virus (HIV) seropositive
- •Pregnancy
- •DONOR: HIV seropositive
- •DONOR: Contraindication or hypersensitivity to filgrastim or plerixafor
- •DONOR: Hepatitis A, B, C seropositive
- •DONOR: Pregnant or lactating females
- •DONOR: Liver function studies > 2 times the upper limit of normal (ULN) at evaluation, Creatinine > 2, pulmonary function diffusing lung capacity for carbon monoxide (DLCO) < 50% (if specifically evaluated), cardiac ejection fraction < 50% (if specifically evaluated)
- •DONOR: Any known ventricular arrhythmia
研究组 & 干预措施
Filgrastim and plerixafor for PBSC mobilization
Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.
After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
干预措施: filgrastim (Biological)
Filgrastim and plerixafor for PBSC mobilization
Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.
After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
干预措施: plerixafor (Drug)
Filgrastim and plerixafor for PBSC mobilization
Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.
After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
干预措施: peripheral blood stem cell transplantation (Procedure)
Filgrastim and plerixafor for PBSC mobilization
Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.
After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
干预措施: allogeneic hematopoietic stem cell transplantation (Procedure)
结局指标
主要结局
Successful Collection of Stem Cells
时间窗: At the end of apheresis for cell collection
Percentage of donors from whom at least 2 x 10\^6 CD34+ cells/kg body weight were collected based on actual recipient body weight
次要结局
- CD34-positive Cells Collected(At the end of apheresis for cell collection)