NCT00384111终止3 期
A Phase 3 Open Label Multicenter, Randomized Study to Compare the Efficacy and Safety of the Zevalin (Ibritumomab Tiuxetan) Therapeutic Regimen Following Cyclophosphamide, Vincristine, Prednisone, and Rituximab (R-CVP) With R-CVP Alone in High-Risk Subjects With Previously Untreated CD20-Positive Follicular Non-Hodgkin's Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 6
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This study will treat follicular lymphoma patients who have not received previous treatment with R-CVP. Half of the patients will receive Zevalin after R-CVP and the other half will receive only R-CVP. The two patient groups will be compared to determine if Zevalin given after R-CVP therapy provides greater benefits than receiving no additional anti-cancer therapy after R-CVP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information).
- •Age greater than or equal to 18 years at the time of informed consent.
- •Histologically confirmed follicular NHL according to the Revised European American Lymphoma (REAL)/World Health Organization (WHO)classification (from initial diagnosis); grades 1, 2, or
- •Bi-dimensionally measurable lesion(s) in at least one site.
- •High risk NHL as defined by a follicular lymphoma international prognostic index (FLIPI) of 3, 4, or 5 assessed within 3 months prior to randomization.
- •NHL requires treatment as determined by the investigator.
- •Confirmed CD20+ lymphoma cells.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1,or
- •Expected survival of greater than or equal to 3 months.
- •Male subjects and female subjects of child bearing potential willing to practice effective contraception during the study and willing and able to continue contraception for 1 year after their last dose of study treatment (R CVP for subjects in the observation arm and the Zevalin therapeutic regimen for subjects in the Zevalin arm).
排除标准
- •Previous anticancer treatment for NHL, including chemotherapy, immunotherapy, radiation (locoregional or extended field), radioimmunotherapy, or investigational therapy.
- •Known seropositivity for hepatitis C virus, hepatitis B virus (surface antigen-positive), or other active infection uncontrolled by treatment.
- •Known diagnosis of human immunodeficiency virus infection.
- •Presence of primary gastric, central nervous system (CNS), or testicular lymphoma, or transformed lymphoma, or chronic lymphocytic leukemia (CLL).
- •Active therapy within previous 5 years for other malignancy, except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
- •Abnormal liver function: total bilirubin >1.5 X upper limit of normal (ULN) or ALT >2.5 X ULN.
- •Impairment of renal function (serum creatinine >1.5 X ULN) not due to lymphoma.
- •Concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) that could compromise participation in the study.
- •Known hypersensitivity to murine and/or chimeric proteins.
- •History of severe allergic or anaphylactic reactions.
- •Known allergy to any components present in rituximab, cyclophosphamide, vincristine, and prednisone (CVP), or Zevalin.
- •Treatment with another study treatment or approved therapy for investigational use within the 12 weeks prior to randomization.
- •Exposure to monoclonal antibodies, cytokines, growth factors, soluble receptors, other recombinant products, or fusion proteins.
- •Females with a positive pregnancy test result at screening or who are currently breastfeeding.
- •Inability to comply with study requirements.
- •Major surgery within 28 days except for diagnosis.
- •In need of immediate intervention to treat life threatening complications.
研究组 & 干预措施
1
Experimental
Participants will receive standard R-CVP followed by Zevalin Therapeutic Regimen (Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin).
干预措施: Zevalin Therapeutic Regimen (Drug)
1
Experimental
Participants will receive standard R-CVP followed by Zevalin Therapeutic Regimen (Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin).
干预措施: R-CVP (Drug)
2
Active Comparator
Participants will receive standard R-CVP.
干预措施: R-CVP (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 18 months
次要结局
- Number of Participants With Serious and Non-serious Adverse Events(18 months)
研究者
研究点 (6)
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