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PURPOSE: This phase II trial is studying how well apolizumab works in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
- 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.
- Determine the safety of this drug, in terms of the frequency and severity of treatment-related adverse events, in these patients.
- Correlate clinical response with genetic subtype of leukemia or lymphoma in patients treated with this drug.
- Correlate pharmacokinetic clearance of this drug with 1D10 antigen density on leukemic or lymphoma cells and with response to and toxic effects associated with this drug in these patients.
- Correlate clinical response with reactive oxygen species and specific signaling pathways' promotion of drug-mediated apoptosis in patients treated with this drug.
- Determine the cellular properties that convey resistance to this drug in CLL in vivo in these patients.
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.
PROJECTED ACCRUAL: A total of 17-32 patients will be accrued for this study within 8.5-32 months.
Masking: Open Label, Primary Purpose: Treatment
Rebecca and John Moores UCSD Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:54:10-0400
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