Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 7
- 主要终点
- Overall response rate
研究概览
简要总结
90Y Ibritumomab tiuxetan (zevalin) has demonstrated consistently high response rates in patients who have received previous treatment for lymphoma. More than two-thirds of the patients who achieve CR go on to experience durable remissions lasting for years. Despite these highly promising clinical results with radioimmunotherapy (RIT) in relapsed follicular lymphoma there is very little data using RIT in previously untreated follicular lymphoma. The objective of this trial is to evaluate the safety and efficacy of two fractions of Zevalin in patients with previously untreated follicular lymphoma in a Phase II study.
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
- •Patients must have a histologically confirmed CD20 +ve follicular lymphoma grades I to IIIa.
- •Patients with at least one of the following symptoms requiring initiation of treatment: (as outlined by the modified BNLI/GELF criteria below)
- •Nodal mass > 7cm in its greater diameter
- •B symptoms
- •Elevated serum LDH or beta2-microglobulin
- •involvement of at least 3 nodal sites (each with a diameter > 3 cm)
- •symptomatic splenic enlargement
- •compressive syndrome
- •Patients must have an ECOG performance status less than or equal to 2 and an anticipated survival of at least 6 months.
- •Patients must have an absolute granulocyte count of above 1,500/mm3, and a platelet count of above 100,000/mm3 post 4 weeks of unlabelled Rituximab. A hemoglobin >= 8.0 g/dl
- •Patients must have adequate renal function (defined as calculated creatinine clearance > 30 ml/mn), hepatic function (defined as total bilirubin <1.5 times upper limit of normal), and hepatic transaminases (defined as AST <5 times upper limit of normal)
- •Patients must have given informed consent prior to study entry.
排除标准
- •Patients with a mean of >20% of the intratrabecular marrow space involved with lymphoma on bone marrow biopsy following induction Rituximab therapy.
- •Transformed follicular lymphoma and discordant lymphoma
- •Patients with active obstructive hydronephrosis.
- •Patients with initial disease bulk greater than 10cm.
- •Patients with evidence of active infection requiring i.v. antibiotics at the time of study entry.
- •Patients with congestive heart failure stage III or IV of NYHA classification, myocardial infraction or unstable angina within 6 months or other serious illness that would preclude evaluation.
- •Patients with left VEF < 40%
- •Patients with large pleural or peritoneal effusions.
- •Patients with known HIV infection or active HBV (HbsAg positivity) or HCV infection.
- •Known Hypersensitivity to murine antibodies or proteins
- •Patients who are pregnant or breast-feeding. Male and female patients must agree to use effective contraception for 12 months following 90Y-ibritumomab tiuxetan antibody therapy.
- •Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer, cervical cancer in situ, or other cancer for which the patient has been disease-free for 5 years.
研究组 & 干预措施
Fractionated Initial Zevalin
干预措施: 90Y Ibritumomab tiuxetan (Drug)
Fractionated Initial Zevalin
干预措施: Rituximab (Drug)
结局指标
主要结局
Overall response rate
时间窗: Assessed 3 months post treatment
According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.
Combined Complete Response rate
时间窗: Assessed 3 months post treatment
According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.
Partial Response Rate
时间窗: Assessed 3 months post treatment
According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.
次要结局
- Response duration(Assessed 3 months post treatment, repeated assessment up to 5 years follow-up)
- Time to disease progression(Assessed 3 months post treatment, repeated assessment up to 5 years follow-up)
研究者
Emmie Taylor
Lead Clinical Trial Manager
The Christie NHS Foundation Trust