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Sponsors and Collaborators: |
Stanford University Berlex Oncology |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00230282 |
The purpose of the study is to evaluate the safety and efficacy of fludarabine and cyclophosphamide followed by subcutaneous Campath® in previously untreated CLL patients. Another goal is to prospectively evaluate the influence of pre-treatment CD38 expression, immunoglobulin VH gene mutation status, Zap70 expression, and cytogenetic abnormalities on outcome. In addition, the study hopes to further evaluate treatment efficacy with quantitative assessments of minimal residual disease by flow cytometry for the CLL-specific CD19+/CD5+/CD20+/CD79b+ population.
Condition | Intervention | Phase |
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Leukemia, B-Cell, Chronic |
Drug: Campath |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center Phase II Efficacy and Pharmacokinetic Study Evaluating Fludarabine, Cyclophosphamide, and Subcutaneous Campath (FCCam) for Previously Untreated B-Cell Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 100 |
Study Start Date: | July 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:- Male or female, age 18 or older, with a confirmed immunohistological diagnosis of CLL
Patients with Rai Stage I - II or (Modified Rai Intermediate-Risk) disease must have an indication for therapy based on 1996 NCI revised criteria for active disease as follows:
Any one of the following disease-related symptoms:
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Steven Edward Coutre | Stanford University |
Study ID Numbers: | HEMCLL0001, 31185, 80071, HEMCLL0001, NCT00230282 |
Study First Received: | September 28, 2005 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00230282 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Chronic lymphocytic leukemia Leukemia, Lymphoid Immunoproliferative Disorders Leukemia, B-cell, chronic Cyclophosphamide Fludarabine monophosphate Leukemia |
Lymphatic Diseases Leukemia, Lymphocytic, Chronic, B-Cell Alemtuzumab Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |