Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- To assess safety of parathyroid hormone in combination with G-CSF when used as a mobilization agent at four different dosing levels.
研究概览
简要总结
The purpose of this study is to determine the safety of parathyroid hormone in combination with G-CSF when used as a stem cell mobilization regimen for patients who fail to mobilize sufficient progenitor stem cells after one or two attempts.
详细描述
Patients will start treatment within 21 days of the determination of inadequate mobilization. PTH treatment will be given in 4 cohorts: 40 mcg, 60 mcg, 80 mcg, and 10 mcg. PTH will be given on day 1 and continue until stem cell collections are complete or a maximum of 20 days. G-CSF 10 mcg/kg will be given on days 10-14 and continue until stem cell collections are complete. Patients with inadequate CD34+ cells on Day 14 will meet off study criteria and not continue with PTH/G-CSF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease status: NHL or HD refractory to chemotherapy, relapsed, o high risk first remission; multiple myeloma; AML in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder.
- •Failed one or two mobilization attempts.
- •ECOG performance status of 0, 1, or 2.
排除标准
- •Cardiac disease: symptomatic congestive heart failure, angina pectoris or uncontrolled hypertension
- •Pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease.
- •Renal disease: serum creatinine > 2 mg/dl
- •Hepatic disease: SGOT or SGPT > 3x normal; serum bilirubin > 2.0 mg/dl that is not due to Gilbert's syndrome or hemolysis
- •Calcium > 10.5
- •Phosphate < 1.6
- •Uncontrolled infection
- •Pregnancy or breast feeding mother
结局指标
主要结局
To assess safety of parathyroid hormone in combination with G-CSF when used as a mobilization agent at four different dosing levels.
次要结局
- To evaluate the peripheral blood CD34+ count after second mobilization.
- To evaluate CD34+ cells/kg from apheresis after second mobilization.
- To evaluate the percent of patients for whom adequate numbers of CD34+ cells are obtained.
- To evaluate transfusion support.
- To evaluate the days to neutrophil engraftment (ANC >500) post autologous transplant.
- To evaluate the days to platelet engraftment (platelet count > 20,000 unsupported).