This phase II trial is studying how well apolizumab works in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Monoclonal antibodies such as apolizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PRIMARY OBJECTIVES: I. Determine the response rate and progression-free survival rate in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or noncontiguous stage II or stage III or IV small lymphocytic lymphoma treated with apolizumab. II. Determine the safety of this drug, in terms of the frequency and severity of treatment-related adverse events, in these patients. SECONDARY OBJECTIVES: I. Determine clinical response to apolizumab varies by genetic subtype of CLL. II. Determine if pharmacokinetic clearance is truly predicted by 1D10 antigen density on the individual patient CLL cell and how apolizumab clearance correlates with response and selected toxicities observed. III. To determine the importance of reactive oxygen species and specific signaling pathways in promoting apolizumab-mediated apoptosis in vitro and in vivo in primary CLL cells and if this correlates with clinical response to therapy. IV. To determine the cellular properties which convey resistance to apolizumab in CLL in vivo. OUTLINE: This is a multicenter study. Patients receive apolizumab IV over 2-4 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 week, at 1 and 2 months, every 3 months for 1 year, and then every 6 months for 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Chronic Lymphocytic Leukemia Research Consortium (CRC)
La Jolla, California, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Response rate (CR+PR)
Time frame: Up to 3 years
Progression-free survival rate
Time frame: Up to 3 years
Frequency and severity of treatment-related adverse events
Time frame: Up to 30 days
Pharmacokinetic clearance
Time frame: Days 1, 2, 3, 5, 8, 15, 22, 26, 27, 29 and 1, 2, 3, and 6 months
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