Subcutaneous Campath-1H in Fludarabine-Refractory CLL
- 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
Safety and efficacy
Stephan Stilgenbauer, MD
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
United States: Federal Government