跳至主要内容
临床试验/NCT00969462
NCT00969462已完成4 期

Association Between Response to Aggressive Chemotherapy and Doxorubicin Pharmacokinetics in Non Hodgkin's Lymphoma Patients

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
18
试验地点
1
主要终点
Doxorubicin, pharmacokinetics at first chemotherapy course

研究概览

简要总结

In previous studies, the investigators found that in patients with Hodgkin's lymphoma (HL) treated with ABVD (adriamycin, bleomycin, vinblastine and decarbazine) the absence of alopecia may predict for a poor response to treatment [complete remission (CR) rate 79% versus 31%, P < 0.0005, respectively]. Also, patients without alopecia had fewer episodes of either leucopenia, neutropenia, deferral of treatment courses or number of courses with dose reduction [88% vs. 62.5%, P=0.05, for the presence of at least one of them].

One of the explanations for this phenomenon is related to a lower systemic exposure of chemotherapeutic drugs in patients who retain their hair. There is a wide interpatient variability in the pharmacokinetic and pharmacodynamic parameters of doxorubicin systemic exposure and the degree of myelosuppression.

In a pilot study on 18 patients the investigators could not find the previous association between alopecia, response to chemotherapy and bone marrow depression. However, when analyzing doxorubicin pharmacokinetics, patients who had no remission had 2 fold lower AUC (area under the curve) and 3 fold lower peaks (p=0.06). The investigators' lack to approve the previous findings might be explained by the small study group.

详细描述

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

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Do not meet all inclusion criteria

研究组 & 干预措施

Doxorubicin

No Intervention

Single arm

干预措施: Doxorubicin (Drug)

结局指标

主要结局

Doxorubicin, pharmacokinetics at first chemotherapy course

时间窗: 1 year

次要结局

  • Association between doxorubicin pharmacokinetics and response(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验