Leukemia Clinical Trial
Official title:
Subcutaneous Campath-1H in Fludarabine-Refractory CLL
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different
ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells
and help kill them or carry cancer-killing substances to them.
PURPOSE: This phase II trial is studying how well giving alemtuzumab by injection works in
treating patients with advanced chronic lymphocytic leukemia that did not respond to
previous fludarabine.
OBJECTIVES:
- Compare the safety and efficacy of subcutaneous alemtuzumab vs intravenous alemtuzumab
in patients with fludarabine-refractory advanced chronic lymphocytic leukemia.
- Determine the response in patients with high-risk genetic abnormalities (unmutated
immunoglobulin variable heavy-chain [IgVH] status, del [17p], del [11q]) treated with
subcutaneous alemtuzumab after progression on fludarabine.
OUTLINE: This is a multicenter study.
Patients receive alemtuzumab IV once, followed 1 week later by alemtuzumab subcutaneously
once weekly for up to 12 weeks.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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