Alemtuzumab in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Fludarabine
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|ClinicalTrials.gov Identifier: NCT00274976|
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: alemtuzumab||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Subcutaneous Campath-1H in Fludarabine-Refractory CLL|
|Study Start Date :||September 2002|
|Actual Study Completion Date :||August 2009|
- Safety and efficacy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274976
|OverallOfficial:||Stephan Stilgenbauer, MD||Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm|