Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Consolidation Therapy With Alemtuzumab (MabCampath®) in Patients With Chronic Lymphocytic Leukemia Who Are in Complete or Partial 2nd Remission After Cytoreduction With Fludarabine or Fludarabine Plus Cyclophosphamide or Fludarabine Plus Cyclophosphamide Plus Rituximab or Bendamustine or Bendamustine Plus Rituximab - a Phase I/II Study
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 I/II trial is studying the side effects and best dose of alemtuzumab in
treating patients with B-cell chronic lymphocytic leukemia.
OBJECTIVES:
- To determine the safest dose of alemtuzumab as consolidation therapy in patients in
second remission after fludarabine phosphate alone; fludarabine phosphate and
cyclophosphamide; fludarabine phosphate, cyclophosphamide, and rituximab; bendamustine
hydrochloride alone; or bendamustine hydrochloride and rituximab.
- To determine the frequency of cytomegalovirus reactivations or infections during or
after alemtuzumab treatment.
- To determine which dose of alemtuzumab is efficient to eliminate minimal residual
disease in peripheral blood and bone marrow (i.e., to turn a clinical partial remission
into a clinical complete remission [CR], to turn a flow cytometry-positive CR into a
flow cytometry-negative CR, or to turn a PCR-positive CR into a PCR-negative CR).
- To determine the pharmacokinetic profile of alemtuzumab.
- To compare the pharmacokinetic profile between intravenous versus subcutaneous
administration of alemtuzumab.
OUTLINE: This is a multicenter, dose-escalation study of alemtuzumab.
- Group 1: Patients receive escalating doses of alemtuzumab IV over 2 hours once weekly
for 8 weeks until the maximum tolerated dose (MTD) is determined.
- Group 2: Patients receive escalating doses of alemtuzumab subcutaneously once weekly for
8 weeks, beginning with the MTD determined in group 1 until a second MTD is determined.
Patients undergo bone marrow and blood sample collection periodically for laboratory and
pharmacokinetic studies. Samples are analyzed for minimal residual disease and T-cell subsets
(i.e., CD4 and CD8) via quantitative-PCR analysis and flow cytometry and cytomegalovirus
antigens via PCR.
After completion of study treatment, patients are followed at 3, 6, 9, 12, 18, and 24 months.
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