NCT00902525终止2 期
Two Repeated Doses of Yttrium-90 Ibritumomab Tiuxetan (Zevalin®) as Salvage Treatment for Patients With Relapsed or Refractory Aggressive B-cell Lymphoma: a Phase II Study.
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie12 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 12
- 主要终点
- An interim analysis on all the available data after the enrolment of the 15th patient (completion of the 1st stage) will be conducted, both for safety and efficacy.
研究概览
简要总结
Despite of the availability of treatment for this disease, this study is justified because no known therapies are really curative and it is necessary to look for new treatment options to improve the clinical outcome and prognosis of relapsed aggressive lymphoma. This study is designed for patients not eligible for high-dose chemotherapy and autologous stem cells transplantation.
详细描述
The objectives of this study are to evaluate the efficacy and safety of two sequential doses of 90Y-Ibritumomab Tiuxetan administered after salvage chemotherapy in patients with relapsed/refractory aggressive lymphoma non-eligible for HDC and ASCT.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CD20+ B-diffuse large cell de novo or transformed or follicular lymphoma grade IIIb
- •Stage II, III, IV according to Ann Arbor criteria
- •Chemoresistant disease after first line treatment (CHOP-like + Rituximab) or relapsed patients after one or two lines of chemotherapy not-eligible for high dose chemotherapy and autologous stem cell transplantation
- •Performance status 0-2 according to WHO criteria
- •HIV negativity
- •Normal liver, lung and kidney function: conjugated bilirubin up to 2 x ULN, alkaline phosphatase and transaminases up to 2 x ULN, creatinine clearances ≥45 ml/min
- •Neutrophils count ³ 1.5 x 109/l, Haemoglobin ³ 9 g/dl, Platelets ³ 150 x 109/l and bone marrow involvement < 25% before first Zevalin infusion.
- •Neutrophils count ³ 1.5 x 109/l, Haemoglobin ³ 9 g/dl, Platelets ³ 100 x 109/l before second Zevalin infusion
- •Use of effective contraception for the entire treatment period in patients sexually active
- •Negative pregnancy test in child bearing potential women
- •Life expectancy > 6 months
- •Written informed consent
排除标准
- •More than two lines of prior chemotherapy before study entry
- •Prior high dose chemotherapy and autologous stem cell transplantation
- •HIV positivity
- •HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
- •HCV positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
- •History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
- •Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug
- •Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 5, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
- •Pregnant or breastfeeding
- •CNS lymphoma involvement.
- •History of malignant carcinoma within the last 3 years other than squamous cell and basal cell carcinoma.
- •Cardiac failure with VEF < 40%
- •Clinical evidence of not controlled infections
研究组 & 干预措施
90Y-Ibritumomab Tiuxetan double dose
Experimental
90Y-Ibritumomab Tiuxetan administered at 0.4 mCi/kg at phase 2 and then at 0.2 mCi/kg at phase 3
干预措施: 90Y-Ibritumomab Tiuxetan (Drug)
结局指标
主要结局
An interim analysis on all the available data after the enrolment of the 15th patient (completion of the 1st stage) will be conducted, both for safety and efficacy.
时间窗: after the enrolment of the 15th patient
次要结局
- after the interim analysis, the writing committee of the study will evaluate to increase the second dose of Zevalin to 0.3 mCi/Kg. The same procedure will be applied to decide if the trial must be stopped after the enrolment of the 23rd patient.(after the enrolment of the 23rd patient)
研究者
研究点 (12)
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