Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL) (MDX1342-02)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- incidence and severity of treatment-emergent adverse events [ Time Frame: all events will be followed to resolution ] [ Designated as safety issue: Yes ]
- response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- clinical laboratory tests [ Time Frame: study duratation - each visit ] [ Designated as safety issue: Yes ]
- physical examination [ Time Frame: study duration - each visit ] [ Designated as safety issue: Yes ]
- electrocardiogram [ Time Frame: at screening and study completion ] [ Designated as safety issue: Yes ]
- diagnostic testing [ Time Frame: at screening and study completion ] [ Designated as safety issue: No ]
- pharmacokinetics sampling [ Time Frame: at each dosing visit ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Estimated Study Completion Date:||March 2011|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Patients will receive active 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, 40, 200, 1000, 2000 mg/dose.
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.
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|United States, Texas|
|Oncology Consultants, PA|
|Houston, Texas, United States, 77024|
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|