A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This clinical trial studies etoposide, filgrastim and plerixafor in improving stem cell mobilization in patients with non-Hodgkin lymphoma. Giving colony-stimulating factors, such as filgrastim, and plerixafor and etoposide together helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored.
详细描述
PRIMARY OBJECTIVES:
I. To determine whether the addition of plerixafor improves the proportion of patients with lymphoma who collect >= 8 x 10^6 cluster of differentiation (CD)34+ cells/kg within two days by 25% compared to the historical estimate of 42% with etoposide and G-CSF (filgrastim).
II. To determine whether patients achieving collection of >= 8 x 10^6 CD34+ cells/kg have a 15% one year survival advantage relative to the historical estimate of 68% among patients mobilizing >= 2 but < 8 x 10^6 CD34+ cells/kg with etoposide and G-CSF.
SECONDARY OBJECTIVES:
I. To demonstrate that patients receiving >= 8 x 10^6 CD34+ cells/kg have more rapid neutrophil and platelet recovery and earlier hospital discharge than those receiving < 8 x 10^6 CD 34+ cells/kg.
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 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have biopsy-confirmed non-Hodgkin lymphoma, of any type
- •Must be eligible for autologous transplantation according to institutional guidelines
- •Eastern Cooperative Oncology Group performance status of 0 or 1
- •Karnofsky performance status of 70 to 100
- •Negative for human immunodeficiency virus (HIV)
- •prior to the start of mobilization, subjects must have:
- •Absolute neutrophil count of >= 1.2 x 10^9/L
- •Platelet count of >= 100 x 10^9/L
- •Creatinine clearance >= 30 mL/minute
- •All patients must be able to comprehend and sign informed consent
- •If childbearing potential must either agree to complete abstinence from heterosexual intercourse or effective means of contraception during stem cell mobilization and for at least 3 months following last plerixafor dose; female patients will undergo pregnancy test prior to stem cell mobilization therapy
排除标准
- •Have had previous transplants and/or prior mobilization attempts
- •Have evidence of progressive non-Hodgkin lymphoma
- •Have evidence of bone marrow involvement of lymphoma at time of transplant staging
- •Had evidence of active central nervous system (CNS) involvement
- •Have had previous radiation of the pelvic area
- •Have had prior radioimmunotherapy
- •Have received experimental therapy within 2 weeks of enrollment
- •Be currently enrolled in another investigational protocol
- •Have prior history of other malignancies, excluding basal cell carcinoma or squamous cell carcinoma of the skin
研究组 & 干预措施
Treatment (stem cell supermobilization)
Patients receive etoposide IV over 4 hours on day 0, filgrastim SC QD beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician.
干预措施: plerixafor (Drug)
Treatment (stem cell supermobilization)
Patients receive etoposide IV over 4 hours on day 0, filgrastim SC QD beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician.
干预措施: filgrastim (Biological)
Treatment (stem cell supermobilization)
Patients receive etoposide IV over 4 hours on day 0, filgrastim SC QD beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician.
干预措施: etoposide (Drug)
Treatment (stem cell supermobilization)
Patients receive etoposide IV over 4 hours on day 0, filgrastim SC QD beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician.
干预措施: leukapheresis (Procedure)
结局指标
主要结局
Overall Survival
时间窗: Up to 1 year post-transplant
Number of participants who receive greater than or equal to 8 x 10\^6 CD34+ cells/kg by 15% following collection with plerixafor, etoposide, and filgrastimstill alive at 1 yr post transplant
Collection Using Plerixafor, Etoposide, and Filgrastim
时间窗: Within 2 days of apheresis
Number of participants able to collect equal to or more than 8 x 10\^6 CD34+ cells/kg with addition of plerixafor to etoposide and filgrastim. These participants are defined as supermobilizers. Participants with less than 8 x 10\^6 CD34+ cells/kg are defined as normal mobilizers.
Progression-free Survival
时间窗: Up to 1 year post-transplant
The number of participants of patients who receive greater than or equal to 8 x 10\^6 CD34+ cells/kg following collection with plerixafor, etoposide, and filgrastim and that have progression-free survival at one year
次要结局
- Platelet Recovery in Super Mobilizers and Normal Mobilizers(Up to 28 days post treatment)
- Neutrophil Recovery in Super Mobilizers and Normal Mobilizers(Up to 28 days post treatment)
- Overall Survival in Supermobilizers and Normal Mobilizers(Up to 1 year post-transplant)
- Number of Days of Apheresis Required(Up to 28 days post treatment)
- Length of Hospital Stay in Super Mobilizers and Normal Mobilizers(Up to 28 days post treatment)
- Progression-free Survival in Supermobilizers and Normal Mobilizers(Up to 1 year post-transplant)
- Number of Transfusion Requirements(Up to 28 days post treatment)
- Need for Remobilization(Up to 28 days post treatment)
- Correlation of Peripheral CD34+ Cell Count With Graft Content of CD34+ Cells(Up to 28 days post treatment)