Phase II Non-Randomized Study Combining Yttrium 90 Ibritumomab Tiuxetan (Zevalin) With High-Dose Chemotherapy Prior to Autologous Stem Cell Transplantation in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma

McGill University2 个研究点分布在 1 个国家目标入组 40 人开始时间: 2007年3月1日最近更新: 2007年2月27日

适应症

试验速览

阶段: 2 期
发起方: McGill University
入组人数: 40
试验地点: 2
主要终点: Overall response rate

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This aim of this study to evaluate the safety and efficacy of combining a single course of Yttrium 90 Ibritumomab Tiuxetan, a radiolabeled monoclonal antibody ( Zevalin ), with high-dose BEAM chemotherapy and autologous peripheral stem cell transplantation in patients with relapsed, refractory, or transformed Non-Hodgkin's lymphoma.

详细描述

Relapse rates after chemotherapy for relapsed, refractory or transformed Non-Hodgkin's lymphoma (NHL)remain very high. NHL is a radiosensitive tumor. We hypothesize that targeted radioimmunotherapy combined with high-dose chemotherapy may increase response and survival rates in a safe and reliable manner.

研究设计

研究类型: Interventional
分配方式: Non Randomized
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 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Age >=18 to <=70 years
•Relapsed or refractory Stage III or IV, grade 1,2, or 3 Follicular Lymphoma or transformed follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, or diffuse large B-Cell lymphoma as defined by the WHO and:
•Expressing the CD 20 antigen
•ECOG performance 0-2
•Written informed consent
•Prior collection of at least 2.5x10^6 CD34-positive peripheral blood stem cells/kg.

排除标准

•Abnormal renal function (Creatinine >2.5x upper limit of normal (ULN)
•Abnormal hepatic function (Bilirubin >2xULN, ALT/AST >3x ULN)
•Cardiac ejection fraction <40%
•Severe defects in pulmonary function tests (DLCO<70% predicted, FEV1, FVC<60% predicted) or receiving continuous oxygen
•A history of human anti-mouse antibodies (HAMA) or known type 1 hypersensitivity or anaphylactic proteins to any component of the Zevalin therapy.
•Female patients who are pregnant or breast feeding, and adults of reproductive potential who are not employing an effective method of birth control during study treatment
•Prior radiotherapy to >25% of the bone marrow or >20 Gy to critical organ (lung, liver, kidney, spinal cord).
•CNS lymphoma
•Ongoing infection
•Prior treatment with radioimmunotherapy

结局指标

主要结局

Overall response rate

次要结局

Survival Data, adverse events, molecular response

研究者

发起方

McGill University

申办方类型

Other

研究点 (2)

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