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Sponsored by: |
Medarex |
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Information provided by: | Medarex |
ClinicalTrials.gov Identifier: | NCT00593944 |
The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses that patients may have to the drug will also be collected.
Condition | Intervention | Phase |
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Chronic Lymphocytic Leukemia |
Biological: MDX-1342 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1, Open-Label, Multiple-Dose, Dose-Escalation Study of MDX-1342 in Patients With CD19-Positive Refractory/Relapsed Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 52 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Patients will receive active MDX-1342.
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Biological: MDX-1342
MDX-1342 is given as a 90 minute i.v. infusion. Patients will receive one of the following dose levels, 0.7, 7, 21, 70, 210, 700 or 2100 mg/dose.
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Chronic lymphocytic leukemia (CLL) is a monoclonal hematopoietic disorder characterized by a progressive expansions of lymphocytes of B-cell lineage. These small, mature-appearing lymphocytes accumulate in the blood, bone marrow, lymph nodes, and spleen. CLL is a common leukemia in the wester world and accounts for 25% to 30% of adult leukemias. CD19,an integral membrane protein, is expressed by pro-B cells and functions as a co-stimulatory molecule that regulates mature B-cell activation and enhances B-cell proliferation. MDX-1342, a fully human monoclonal antibody, has demonstrated to specifically bind to human CD19 antigen with high affinity. Therefore, it is theorized that MDX-1342 will block activation of B cell stimulation, decreasing the number of cancerous B cell clones.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David Eardley | 1-908-479-2630 | deardley@medarex.com |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263 |
Principal Investigator: | Asher Chanan-Khan, MD | Roswell Park Cancer Institute |
Principal Investigator: | Jennifer Brown, MD, PhD | Dana-Farber Cancer Institute |
Responsible Party: | Roswell Park Cancer Institute ( Asher Chanan-Khan ) |
Study ID Numbers: | MDX1342-02 |
Study First Received: | January 3, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00593944 |
Health Authority: | United States: Food and Drug Administration |
CLL Chronic Lymphocytic Leukemia B cell leukemia lymphocyte |
antibody monoclonal cancer blood |
Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Antibodies Leukemia, Lymphoid Immunoproliferative Disorders |
Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, chronic Lymphoproliferative Disorders Leukemia, B-Cell Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |