Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma
关键词
抽象
描述
Aim of the study:
To evaluate the association between response to chemotherapy, the degree of myelosuppression and the pharmacokinetics of doxorubicin in non-Hodgkin's lymphoma (NHL) patients.
Methods:
Study protocol:
1. At diagnosis
Demographic and clinical parameters be collected (Appendix 1)
2. At course 2:
1. Doxorubicin will be given by 5-7 minutes infusion before the other medications (Doxorubicin doses will be collected (Appendix 1))
2. Blood will be sampled in course 2, at:
0 minutes 30 minutes 120 minutes 24 hours
Two 2ml EDT tubes will be drawn at each time The tubes will be centrifuged at 3000 RPM for 15 min. Plasma samples will be stored in - 700C
3. At the end of chemotherapy courses the following data will be collected (Appendix 2):
1. Episodes of bone marrow depression (leucopenia, neutropenia) Treatment delays Dose reductions Neutropenic fever
2. Remission status
[Complete remission (CR) - disappearance of clinical signs and symptoms of NHL along with normal laboratory and radiological findings].
4. At the end of one year of CR
Remission status
Number of patients: 30
日期
| 最后验证: | 02/29/2012 |
| 首次提交: | 08/16/2009 |
| 提交的预估入学人数: | 08/30/2009 |
| 首次发布: | 08/31/2009 |
| 上次提交的更新: | 06/26/2013 |
| 最近更新发布: | 06/30/2013 |
| 实际学习开始日期: | 08/31/2009 |
| 预计主要完成日期: | 11/30/2011 |
| 预计完成日期: | 11/30/2012 |
状况或疾病
干预/治疗
Drug: Doxorubicin
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| No Intervention: Doxorubicin Single arm | Drug: Doxorubicin measurements of serum Doxorubicin levels |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Age ≥ 18 years - Biopsy proven intermediate grade NHL - No previous chemotherapy - At least 4 courses of R-CHOP at maximal doses are planned - An informed consent Exclusion Criteria: - Do not meet all inclusion criteria |
结果
主要结果指标
1. Doxorubicin, pharmacokinetics at first chemotherapy course [1 year]
次要成果指标
1. Association between doxorubicin pharmacokinetics and response [1 year]
