Predictive Value of the "Cytocapacity Test" Following a Single-dose of rHu-G-CSF in Patients With Lymphoproliferative Diseases and High-dose Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 主要终点
- Incidence of infections
研究概览
简要总结
This investigator initiated trial was a prospective, open, single-arm, diagnostic-prognostic study. Patients who received high-dose therapy with autologous stem cell transplantation for the treatment of their lymphoproliferative disease were included into the study.
After completion of the high-dose therapy (day -2 with respect to the stem cell transplantation) the first blood sample A for the cytocapacity test with determination of leukocytes and neutrophils was taken in the evening of day -1. Directly thereafter the study medication was administered. The second blood sample B for the cytocapacity test with determination of leukocytes and neutrophils was taken in the morning of day 0, 12-14 hours after administration of the study medication. Thereafter the stem cell re-infusion was performed.
The primary objective of this study was to show that the cytocapacity test with lenograstim is a useful predictive tool with respect to the risk of post-transplant complications and prolonged myelosuppression, typically occurring after high-dose chemotherapy.
The primary variables were:
- the rate of patients with documented infections
- the time to platelet engraftment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Presence of histologically proven lymphoproliferative disease specified as Hodgkin's disease, non-Hodgkin's lymphoma (NHL) or multiple myeloma
- •Indication of high-dose therapy and autologous peripheral blood stem cell transplantation
- •Availability of a sufficient amount of blood stem cells (CD34+ cells >= 2.0 x 106/kg)
- •Age between 18 and 70 years
- •High-dose therapy with one of the following high-dose regimes: Melphalan 140 mg/m2 or 200 mg/m2, BEAM, BEAC, BUCY or CBV (the last permitted according to amendment 2, see Section 9.8.1)
- •Patient's written consent to participation in this trial
排除标准
- •Previous high-dose therapy and blood stem cell transplantation except for melphalan 140 mg/m2 or 200 mg/m2 in patients with multiple myeloma who did not participate in the cytocapacity test previously (according to amendment 2, see Section 9.8.1).
- •Known intolerance to lenograstim
- •Out-patient therapy following high-dose therapy and blood stem cell transplantation
- •Myocardial infarction < 6 months prior to inclusion into the study
- •Cardiac arrhythmias Lown IV b
- •Clinically manifest cardiac insufficiency (> NYHA II)
- •Renal insufficiency with serum creatinine > 2 mg%
- •Hepatic diseases with elevated levels of transaminases and bilirubin greater than 3-fold above normal
- •Severe infections (HIV, Hepatitis B/C)
- •Severe psychiatric diseases
- •Non-curative treatment of other malignoma within the past 5 years
- •Pregnant women or women breast-feeding
研究组 & 干预措施
A: lenograstim
total group
干预措施: lenograstim (Drug)
结局指标
主要结局
Incidence of infections
Time to platelet engraftment
次要结局
未报告次要终点