A Randomized Controlled Trial Evaluating the Use of G-CSF After Plerixafor-Mobilized Autologous Stem Cell Transplant (Auto HSCT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Number of Days to Discharge
研究概览
简要总结
This phase II trial studies how well stem cell transplant with or without tbo-filgrastim works in treating patients with multiple myeloma or non-Hodgkin lymphoma. Eliminating the use of tbo-filgrastim after transplant may still help maintain a similar time to discharge.
详细描述
PRIMARY OBJECTIVE:
I. To demonstrate non-inferiority in the number of days to discharge readiness after a granulocyte colony-stimulating factor (G-CSF) + plerixafor-mobilized autologous stem cell transplant in patients receiving versus not receiving post-transplant growth factor support.
SECONDARY OBJECTIVE:
I. To compare days to absolute neutrophil count (ANC) > 500, days to platelet engraftment, febrile days, days of febrile neutropenia, documented infections, and number of antibiotic days in patients receiving versus not receiving post-transplant growth factor support.
EXPLORATORY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing autologous stem cell transplant for one of the following diagnoses:
- •Multiple myeloma
- •Non-Hodgkin lymphoma
- •Karnofsky performance status of >= 70%
- •Patients must meet the Thomas Jefferson University Hospital (TJUH) bone marrow transplant (BMT) standard of procedure (SOP) guidelines for "Patient Criteria for Autologous HSCT"
- •Left ventricular ejection fraction (LVEF) of ≥ 40%
- •Adjusted Carbon monoxide diffusing capability (DLCO) > 45% of predicted corrected for hemoglobin
- •Serum bilirubin < 1.8
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 X upper limit of normal
- •Serum creatinine =< 2.0 mg/dl and/or creatinine clearance of > 40 ml/min (excludes multiple myeloma patients receiving high dose melphalan conditioning)
- •Willingness to use contraception if childbearing potential
- •Has the ability to give informed consent, or for cognitively or decisionally impaired individuals (vulnerable population), the availability of a family member or guardian to give consent and assist in the consent process
- •Life expectancy of > 12 months (exclusive of the disease for which the auto HSCT is being performed)
- •Patients must have undergone stem cell mobilization with the combination of G-CSF and plerixafor as per TJUH BMT SOP guidelines
- •Collection of an adequate number of CD34+ stem cells, i.e. >= 4-6 x 10^6/kg from apheresis
排除标准
- •Uncontrolled human immunodeficiency virus (HIV)
- •Uncontrolled bacterial infection
- •Active central nervous system (CNS) disease
- •Pregnancy or lactation
- •Evidence of another malignancy, exclusive of a skin cancer that requires only local treatment
研究组 & 干预措施
Group I (auto HSCT tbo-filgrastim)
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
干预措施: Hematopoietic Cell Transplantation (Procedure)
Group I (auto HSCT tbo-filgrastim)
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
干预措施: Tbo-filgrastim (Drug)
Group I (auto HSCT tbo-filgrastim)
Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
干预措施: Laboratory Biomarker Analysis (Other)
Group II (auto HSCT)
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
干预措施: Hematopoietic Cell Transplantation (Procedure)
Group II (auto HSCT)
Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Number of Days to Discharge
时间窗: Up to 60 days
Will compare days to discharge readiness between the two groups.
次要结局
- Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment(Up to 60 days)
- Median Days Post Auto HSCT to Platelet Engraftment(Up to 60 days)
- Percentage of Participants With Engraftment Syndrome(Up to 60 days)
- Median Number of Febrile Days During the Auto HSCT Inpatient Stay(Up to 60 days)
- Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay(Up to 60 days)
- Median Number of Documented Infections Treatment During the Auto HSCT Inpatient Stay(Up to 60 days)
- Median Number of Antibiotic Days During the Auto HSCT Inpatient Stay(Up to 60 days)
- Percentage of Participants Receiving Corticosteroids(Up to 60 days)
- Percentage of Participants With Post Discharge Granulocyte Colony-stimulating Factor Administrations Through Day +60 Post Auto HSCT(Up to 60 days)