临床试验/NCT00031642

NCT00031642已完成1 期

Phase I/II Study of IDEC-Y2B8 (Zevalin) for Post Transplant Relapses of B-Cell Non-Hodgkin's Lymphoma

University of Nebraska2 个研究点分布在 1 个国家目标入组 26 人开始时间: 2002年1月1日最近更新: 2023年12月27日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: University of Nebraska
入组人数: 26
试验地点: 2
主要终点: Maximum tolerated dose

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

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver cancer-killing substances to them without harming normal cells. Radiolabeled monoclonal antibodies can locate and deliver radioactive cancer-killing substances.

PURPOSE: Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibodies with rituximab in treating patients who have non-Hodgkin's lymphoma that has not responded to high-dose chemotherapy and autologous stem cell transplantation.

详细描述

OBJECTIVES:

Determine the maximum tolerated dose of yttrium Y 90-labeled ibritumomab tiuxetan when administered with rituximab in patients with B-cell non-Hodgkin's lymphoma who have relapsed after high-dose chemotherapy and autologous hematopoietic stem cell transplantation.
Determine the safety and efficacy of this regimen in these patients.

OUTLINE: This is a dose-escalation study of yttrium Y 90-labeled ibritumomab tiuxetan (IDEC-Y2B8).

Phase I: Patients receive rituximab IV over 4-6 hours followed by indium In 111-labeled ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0. Patients receive rituximab IV again on day 7 followed by IDEC-Y2B8 IV over 10 minutes.

Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity.

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: 19 Years 至 120 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of relapsed B-cell non-Hodgkin's lymphoma (NHL) after high-dose chemotherapy and autologous stem cell transplantation
•Less than 25% bone marrow involvement with NHL as evidenced by unilateral or bilateral biopsy within the past 6 weeks
•o Bone marrow biopsy should demonstrate 15-20% of cellular space occupied by normal hematopoiesis
•CD20 antigen expression in tumor tissue within the past year as evidenced by 1 of the following:
•Immunoperoxidase stains of tissue showing positive reactivity with L26 antibody
•Flow cytometry studies
•Measurable disease
•o More than 2 cm bidimensionally
•19 years of age and over
•Performance status WHO 0-2
•Life expectancy at least 3 months
•Absolute neutrophil count greater than 1,500/mm^3
•Platelet count greater than 150,000/mm^3
•Bilirubin less than 2.0 mg/dL
•SGOT or SGPT no greater than 2.5 times upper limit of normal (unless due to lymphomatous infiltration of the liver)
•Creatinine less than 2.0 mg/dL
•Fertile patients must use effective contraception during and for 6 months after study therapy
•HIV negative
•At least 4 weeks since prior growth factors
•At least 4 weeks since prior biologic therapy
•At least 4 weeks since any prior cytotoxic chemotherapy (6 weeks for nitrosoureas)
•At least 4 weeks since prior radiotherapy
•Recovered from all prior therapy
•At least 4 weeks since prior immunosuppressants

排除标准

•No active CNS lymphoma
•No HIV- or AIDS-related lymphoma
•No transfusion dependency
•No active obstructive hydronephrosis
•Not pregnant or nursing/negative pregnancy test
•No active infection requiring oral or IV antibiotics
•No human antimurine antibody positivity
•No other major medical problems
•No dependency on hematopoietic growth factors (e.g., epoetin alfa, interleukin-11, filgrastim [G-CSF], or sargramostim [GM-CSF])
•No prior radioimmunotherapy
•No other concurrent biologic therapy of any kind
•No prior fludarabine
•No concurrent chemotherapy
•No concurrent steroids except as maintenance for non-cancerous disease
•No prior pelvic radiotherapy
•No prior radiotherapy to more than 25% of estimated bone marrow reserve
•No concurrent external beam radiotherapy
•No other concurrent investigational drugs
•No other concurrent anti-cancer therapy

结局指标

主要结局

Maximum tolerated dose

Safety and efficacy

次要结局

未报告次要终点

研究者

发起方

University of Nebraska

申办方类型

Other

责任方

Sponsor

研究点 (2)

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