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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
MDX-1342 is given as a 90 minute i.v. infusion. Patients will receive one of the following dose levels, 0.7, 7, 40, 200, 1000, 2000 mg/dose.
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Oncology Consultants, PA
Houston, Texas, United States
incidence and severity of treatment-emergent adverse events
Time frame: all events will be followed to resolution
response
Time frame: 12 weeks
clinical laboratory tests
Time frame: study duratation - each visit
physical examination
Time frame: study duration - each visit
electrocardiogram
Time frame: at screening and study completion
diagnostic testing
Time frame: at screening and study completion
pharmacokinetics sampling
Time frame: at each dosing visit
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