A Phase I/II Study of Immunotherapy with Subcutaneous Administered Veltuzumab (hA20) in Patients with CD20+ Non-Hodgkin's Lymphoma or Chronic Lyphocytic Leukemia

Immunomedics, Inc.0 个研究点目标入组 46 人开始时间: 2008年2月28日最近更新: 2012年3月19日

试验速览

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•histologically confirmed diagnosis of CD20+ follicular, small lymphocytic lymphoma or marginal zone NHL or CLL;
•either previously untreated or relapsed;
•male or female, age 18 years or older;
•adequate performance status with an estimated life expectancy of at least 6 months;
•patients of childbearing potential must be willing to practice birth control during the study until at least 12 weeks after last infusion;
•women of childbearing potential must have a negative urine or serum pregnancy test;
•sign EC-approved informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•previously untreated NHL patient with Stage I and II disease;
•previously untreated CLL patients with Stage 0-2 disease unless specific treatment indications by NCCN guidelines exist;
•relapsed patients receiving more than 4 prior treatment regimens;
•known central nervous system involvement by lymphoma, HIV lymphoma, transformed lymphoma;
•prior malignancies unless disease free for 5 years;
•rituximab resistant

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