Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center GlaxoSmithKline |
---|---|
Information provided by: | Fred Hutchinson Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT00476047 |
This study is evaluating the use of radioimmunotherapy (Bexxar®) given in addition to chemotherapy (Fludarabine and Rituximab) to try and eliminate any remaining disease and to lower the chance of the CLL from returning. Radioimmunotherapy uses an antibody that is designed to target specific cancer cells such as the CLL cells, and deliver a small targeted dose of radiation to them. In this study we will gather more information about the safety and effectiveness of combining standard therapy, fludarabine and rituximab, with radiolabeled antibody therapy, 131I-tositumomab, also called Bexxar®.
Condition | Intervention | Phase |
---|---|---|
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma |
Drug: Fludarabine Drug: Rituximab Drug: 131TOSITUMOMAB (BEXXAR®) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of 131-Tositumomab (Bexxar) Consolidation In Patients With B-Cell Chronic Lymphocytic Leukemia Following Fludarabine and Rituximab Chemotherapy |
Estimated Enrollment: | 30 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2017 |
Estimated Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Britt E Kammerer, CCRC | 206-667-4174 | bkammere@fhcrc.org |
Contact: Wendy A Wilson, RN, OCN | 206-667-4195 | wwilson@fhcrc.org |
United States, Washington | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109 | |
Principal Investigator: John M Pagel, MD, PhD | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98195 |
Principal Investigator: | John M. Pagel, MD, PhD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( John M. Pagel, MD PhD ) |
Study ID Numbers: | PSOC 2301, IR-6466 |
Study First Received: | May 17, 2007 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00476047 |
Health Authority: | United States: Institutional Review Board |
Leukemia, Lymphocytic, Chronic, B Cell Lymphocytic Leukemia, Chronic, B Cell B Cell Leukemia, Chronic B Lymphocytic Leukemia, Chronic Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Leukemia Lymphoma CLL |
SLL Fludarabine Fludara Rituximab Rituxan Tositumomab Bexxar Initial therapy First line therapy |
Chronic lymphocytic leukemia Leukemia, Lymphoid Immunoproliferative Disorders Rituximab Leukemia, B-cell, chronic Iodine-131 anti-B1 antibody Fludarabine monophosphate Leukemia Lymphatic Diseases |
Antibodies Leukemia, Lymphocytic, Chronic, B-Cell Iodine Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma Immunoglobulins |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Antirheumatic Agents |