NCT00603668已完成1 期
A Phase I/II Study of Immunotherapy With Milatuzumab (hLL1) in Patients With Chronic Lymphocytic Leukemia (CLL)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 10
- 主要终点
- Safety of the anti-CD74 antibody will be evaluated based upon physical examinations, hematology and chemistry laboratory evaluations and toxicity events
研究概览
简要总结
This study will test different doses of anti-CD74 antibody in patients with NHL and/or CLL.
详细描述
Milatuzumab (hLL1, IMMU-115), a humanized anti-CD74 monoclonal antibody. Dose escalation will utilize 4 planned dose regimens with 4.0 or 8.0 mg/kg doses administered intravenously either twice weekly (days 1 and 4) or thrice weekly (days 1, 3 and 5) for 4 consecutive weeks. The four planned dose regimens will be labeled as dose level 1 to 4 corresponding to increasing levels of the total dose of milatuzumab.
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
- •Histologically confirmed diagnosis of recurrent chronic lymphocytic leukemia (by NCI criteria)
- •Received at least one prior treatment with standard therapy (previous antibody therapy is acceptable)
- •Measurable disease (WBC > 5,000 for CLL)
- •See protocol for full list
排除标准
- •Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test Pregnancy testing is not required for post-menopausal or surgically sterilized women
- •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 milatuzumab infusion
- •Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative;
- •Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter
- •Known HIV positive or active hepatitis B or C, or presence of hepatitis B surface antigens or presence of hepatitis C antibody
- •Known autoimmune disease or presence of autoimmune phenomena
- •At least 7 days beyond any infection requiring antibiotic use.
- •Systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, <20 mg/day, or equivalent) which may continue if unchanged.
- •Substance abuse or other concurrent medical or psychiatric conditions that, in the Investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.
结局指标
主要结局
Safety of the anti-CD74 antibody will be evaluated based upon physical examinations, hematology and chemistry laboratory evaluations and toxicity events
时间窗: over first 12 weeks
次要结局
- Pharmacokinetics (how the drug is processed by the body)(over the first 12 weeks)
- Efficacy (to see if the study drug works) in patients with NHL and CLL(over the first 12 weeks, then over up to 2 years)
- Immunogenicity(over at least first 12 weeks)
- Pharmacodynamics (how the study drug is absorbed by the body)'(over the first 12 weeks, then over 2 years)
- optimal dose(first 12 weeks)
研究者
研究点 (10)
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