GCSF Plus Plerixafor as First-line Treatment for Autologous Stem Cells Harvest in Children With Malignant Diseases in Need for High-dose Chemotherapy With Stem Cell Rescue.
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 主要终点
- Peripheral blood stem cell content by means of percentage of CD34+ cells
研究概览
简要总结
Plerixafor has been intensively used in recent years for harvesting autologous stem cells from lymphoma and myeloma adult patients. Its use is indicated after failure to harvest with GCSF alone. Nevertheless, in the pediatric population its appliance is less well established and the indications are less well confirmed .Several disease states and diagnoses may prompt the anticipation of difficulties in harvesting stem cells using GCSF only. Such patients may benefit utilizing plerixafor in first-line rather than exhausting the stem cell niche with GCSF alone and only than go for plerixafor as second-line rescue procedure.
In this study we propose to examine the applicability and feasibility of harvesting autologous stem cells by means of GCSF + plerixafor in first-line measure for pediatric patients with specific indications.
详细描述
Improve and report outcomes of children undergoing peripheral stem and progenitor cell harvesting applying plerixafor in first-line aphaeresis, including:
Pre-harvesting FACS-derived CD34+ cell number. Number of stem cells harvested. Number of T-cells harvested. Days of hospitalization.
Procedure related toxicity including:
Infections. Line complications. Other organ toxicities.
Compare outcomes of plerixafor-derived stem and progenitor cells harvesting between different pediatric oncological diseases, including high-risk neuroblastoma, high-risk brain tumors, high-risk sarcomas and relapsed lymphomas.
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
- — 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following patients will be included in this study:
- •Patients with high-risk neuroblastoma after third-line chemotherapy. Patients with high-risk medulloblastoma/PNET after spinal irradiation. Patients with primary sarcomas after third or more line therapies, Patients with relapsed lymphomas after third line chemotherapy. Patients with relapsed neuroblastoma, medulloblastoma, lymphoma or sarcoma after previous autologous stem cell transplantation.
- •Age equal to or less than 30 years at time of diagnosis. Patients eligible for AHCT according to their treating protocol or patients with neuroblastoma eligible for 131I-MIBG-therapy.
- •Patients with maligancies disease who candidates to autologous stem cell transplantation ,taking from them autologus stem cell as back up.
排除标准
- •Healthy stem cells donors
- •Patients who older than 30 years
- •Patients with non maligancies disease that candidates to autologous stem cell transplantation
研究组 & 干预措施
Plerixafor
The use of plerixafor as additive measurment for the conventional stem cell collection protocol.
干预措施: Plerixafor (Drug)
结局指标
主要结局
Peripheral blood stem cell content by means of percentage of CD34+ cells
时间窗: After conditioning protocol (4 days of 10mcg/kg GCSF per day), and on the fifth day after one dose of plerixafor 0.24mg/kg, 10 hours before collection - before harvesting. After harvesting - the number of collected CD34+ cells.
1. Peripheral blood stem cell content before harvesting by means of percentage of CD34+ cells, after conditioning protocol (4 days of 10mcg/kg GCSF per day) and after adding one dose of plerixafor 0.24mg/kg 10 hours before collection. 2. Number of CD34+ stem cells that were collected after adding plerixafor with relation to the target number of stem cells needed.
次要结局
未报告次要终点