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临床试验/NCT00002003
NCT00002003已完成2 期

Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas

Lederle Laboratories6 个研究点 分布在 1 个国家开始时间: 2001年8月31日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
试验地点
6

研究概览

简要总结

To determine the efficacy and toxicity of the combination of mitoxantrone hydrochloride ( Novantrone ) and etoposide in the treatment of patients with HIV associated lymphomas.

研究设计

研究类型
Interventional
主要目的
Treatment

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

  • Patients must have the following:
  • Positive HIV antibody, positive HIV culture or antigen capture, or prior diagnosis of AIDS by the CDC criteria.
  • Diagnosis by pathological examination of large cell or immunoblastic lymphoma within measurable or evaluable disease.
  • Pneumocystis carinii pneumonia (PCP) prophylaxis during the course of the study.
  • Signed written informed consent.

排除标准

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.
  • Stage IE Central Nervous System lymphomas.
  • Patients with the following are excluded:
  • More than one previous treatment for lymphoma.
  • Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.
  • Conditions that preclude obtaining an informed consent.
  • Not accessible for scheduled treatment visits or follow-up.
  • Stage IE Central Nervous System (CNS) lymphomas.
  • Prior Medication:
  • Excluded within 2 weeks of study entry:
  • Zidovudine.
  • Excluded:
  • Doxorubicin dosing = or > 300 mg/m
  • Prior Treatment:
  • Received more than one previous treatment regimen for lymphoma.
  • Prophylactic treatment for Pneumocystis carinii pneumonia (PCP) prophylaxis.

研究者

申办方类型
Industry

研究点 (6)

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