NCT00596804已完成1 期
A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non- Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 6
- 主要终点
- Safety of hA20 with this administration schedule and dosing
研究概览
简要总结
This study is being done to assess the safety and tolerance of different doses of humanized hA20 in patients with NHL.
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
- 否
入选标准
- •Male or female, >18 years old
- •Histological diagnosis of CD20+ B-cell NHL (all grades) by WHO lymphoma criteria
- •Failed at least one prior standard chemotherapy regimen for NHL
- •Failed rituximab treatment for relapsed NHL
- •Measurable NHL disease by CT, with at least one lesion >1.5 cm in one dimension
- •Adequate performance status (>70 Karnofsky scale, 0-1 ECOG) with an estimated life expectancy of at least 6 months
- •Adequate hematologic status, without ongoing transfusional support (hemoglobin ≥ 10 g/dL, ANC ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L)
- •Adequate renal and hepatic function, defined as: creatinine ≤ 1.5 x Institution Upper Limit of Normal (IULN), bilirubin ≤ 1.5 x IULN, AST and ALT ≤ 2.5 x IULN
- •Otherwise, <Grade 1 toxicity at study entry by NCI CTC version 2.0, including recovery from all acute toxicities incurred as a result of previous surgery, radiotherapy or chemotherapy, whether investigational or conventional.
- •At least 6 months beyond previous rituximab treatment, 12 weeks beyond autologous stem cell transplant, 4 weeks beyond chemotherapy, other experimental treatments, or any radiation therapy to the index lesion(s).
- •Ability to provide signed, informed consent
排除标准
- •Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test
- •Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last weekly hA20 infusion.
- •Rituximab resistant, defined as having progressed during or within 6 months of rituximab treatment.
- •Excessive toxicity to rituximab (NCI CTC Grade 3 or 4) or known to be HACA positive
- •Prior radioimmunotherapy, including Zevalin or Bexxar,
- •Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative
- •Primary CNS lymphoma, HIV lymphoma or transformed lymphoma, or presence of symptomatic CNS metastases or carcinomatous meningitis.
- •Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter
- •Pleural effusion with positive cytology for lymphoma Known to be HIV positive, or hepatitis B or C positive
- •Known autoimmune disease or presence of autoimmune phenomena.
- •Evidence of infection or requiring antibiotics within 5 days.
- •Corticosteroid use within 2 weeks
- •Prior malignancy with less than a 5-year disease-free interval, excluding nonmelanoma skin cancers and carcinoma in situ of the cervix.
- •Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of studyprocedures and follow-up examinations
结局指标
主要结局
Safety of hA20 with this administration schedule and dosing
时间窗: first 12 weeks, then over 2 years
tolerance of hA20 with this administration schedule and dosing
时间窗: first 12 weeks
immunogenicity of hA20 with this administration schedule and dosing
时间窗: first 12 weeks, as needed over 2 years
次要结局
- Pharmacodynamics of hA20(first 12 weeks, then up to 2 years)
- pharmacokinetics hA20(first 12 weeks, then up to 2 years)
- assess efficacy(4 and 12 weeks, then every 3 months for 2 years)
研究者
研究点 (6)
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