A Pilot Cohort Study of AMD3100 in Combination With G-CSF and Rituximab Compared With AMD3100 in Combination With G-CSF Alone for Mobilization of BPCs in Patients With Relapsed or Refractory NHL or HD Prior to Autologous HPC Transplant
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Summary of Adverse Events (AEs)
研究概览
简要总结
Participants with non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD) will be assigned to one of 2 arms based on the immunophenotype of their lymphoma.
(A)Participants with CD20(-) lymphoma will undergo mobilization with granulocyte colony-stimulating factor (G-CSF) and plerixafor.
(B) Participants with CD20(+) lymphomas will undergo mobilization with rituximab, G-CSF, and plerixafor. They will receive a weekly dose of rituximab beginning 1 week prior to, and continuing until 2 weeks after, the first dose of G-CSF.
Participants in both groups will receive G-CSF twice daily for 4 days. In the evening on Day 4, a dose of plerixafor will be administered. Apheresis will be initiated the next morning. Participants will continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until ≥5*10^6 CD34+ cells/kg are collected.
Participants who are transplanted will be monitored for the time to polymorphonuclear leukocytes (PMN), platelets (PLT), and lymphocyte engraftment. Follow-up assessments will be done at 100 days, and 6 and 12 months post-transplantation.
详细描述
This is a single-center, 2-arm, non-randomized, open-label study to evaluate the safety of plerixafor when used in combination with rituximab (Rituxan®) and granulocyte colony-stimulating factor (G-CSF) in patients with relapsed or refractory Hodgkin disease (HD) or non-Hodgkin lymphoma (NHL).
Participants will be assigned to one of 2 arms based on the immunophenotype of their lymphoma.
(A)Participants with CD20(-) lymphoma will undergo mobilization with G-CSF and plerixafor.
(B) Participants with CD20(+) lymphomas will undergo mobilization with rituximab, G-CSF, and plerixafor. They will receive a weekly dose of 375 mg/m2 rituximab by intravenous (iv) infusion beginning 1 week prior to, and continuing until 2 weeks after, the first dose of G-CSF.
Participants in both groups will receive 7.5 µg/kg G-CSF twice daily (morning and evening) for 4 days. In the evening (approximately 10:00 pm) on Day 4, a dose of plerixafor (240 µg/kg) will be administered. Apheresis will be initiated the next morning, approximately 10 to 11 hours after plerixafor is given. Participants will continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until ≥5*10^6 CD34+ cells/kg are collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
G-CSF plus plerixafor
Participants with CD20- lymphoma
干预措施: G-CSF plus plerixafor (Drug)
G-CSF plus plerixafor and rituximab
Participants with CD20+ lymphoma
干预措施: G-CSF plus plerixafor (Drug)
G-CSF plus plerixafor and rituximab
Participants with CD20+ lymphoma
干预措施: rituximab (Biological)
结局指标
主要结局
Summary of Adverse Events (AEs)
时间窗: Day 1 and up to Day 59 (maximum time before start of chemotherapy)
Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization in participants with CD20- lymphoma or start of rituximab in participants with CD20+ lymphoma) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for seriousness and relatedness to study treatment.
次要结局
- Median Cumulative Number of CD34+ Cells Collected During Apheresis(Days 5-8)
- Median Fold Increase in the Number of CD34+ Cells After Plerixafor Administration(Days 4-5)
- Median Number of Apheresis Days Required to Reach a Minimum of 3*10^6 CD34+ Cells/kg(Days 5-8)
- Median Number of Apheresis Days Required to Reach the Target of 5*10^6 CD34+ Cells/kg(Days 5-8)
- Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment(Days post transplantation (approximately Day 40))
- Median Number of Days to Platelet (PLT) Engraftment(Days post transplantation (approximately Day 40))
- Median Number of Days to Lymphocyte Engraftment(Days post transplantation (approximately Day 40))
- Median Level of CD19+CD2-CD14- B-cells Six Months Post-Transplant(Approximately 7 months (6 months post-transplant))
- Median Level of CD19+CD2-CD14- B-cells Twelve Months Post-Transplant(13 months (12 months post-transplant))
- The Percentage of CD19+CD3-CD14- B-cells of the Total Cells on the First Apheresis Day(Day 5)
- Number of Participants With Durable Engraftment 12 Months After Transplantation(Approximately 13 months (12 months post-transplant ))