Status:
COMPLETED
Alemtuzumab and Rituximab in Treating Patients With High-Risk, Early-Stage Chronic Lymphocytic Leukemia
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and ...
Detailed Description
OBJECTIVES: Primary * Determine the rate of complete and overall response to alemtuzumab and rituximab in patients with high-risk, early-stage chronic lymphocytic leukemia. * Determine the toxicity ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- \* Diagnosis of B-cell chronic lymphocytic leukemia (CLL)
- \- Early-stage, biologically high-risk disease defined by the following criteria:
- Rai stage 0-II (does not meet standard NCI-sponsored Working Group criteria for treatment)
- Clinical and phenotypic features manifested in the peripheral blood, including the following:
- Minimum threshold peripheral blood lymphocyte count of \> 5,000/mm³
- Small-to-moderate peripheral blood lymphocytes with ≤ 55% prolymphocytes
- Monoclonality of B lymphocytes by immunophenotypic evaluation, demonstrating co-expression of CD19, CD5, and CD23 antigens, surface expression of CD20 and CD52, and B-cell monoclonal population defined by light-chain exclusions
- Poor prognosis demonstrated by ≥ 1 of the following high-risk parameters:
- Unmutated human immunoglobulin variable region heavy chain (IgVH) gene and CD38 expression (≥ 30% cells positive on flow cytometry) OR unmutated IgVH ZAP-70 expression (≥ 20% cells positive on flow cytometry) = 11q- = 17p-
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 3.0 times ULN OR direct bilirubin ≤ 1.5 times ULN
- AST ≤ 3.0 times ULN (unless due to hemolysis or CLL)
- Hemoglobin ≥ 9.0 g/dL
- No New York Heart Association class III-IV heart disease
- No myocardial infarction within the past month
- No uncontrolled infection
- No active HIV infection
- No evidence of autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia
- No other active primary malignancy requiring treatment or limiting survival to less than 2 years
- PRIOR CONCURRENT THERAPY:
- No prior treatment for CLL
- Prior corticosteroids allowed
- No prior radiotherapy
- More than 4 weeks since prior major surgery
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00436904
Start Date
December 1 2004
End Date
November 1 2011
Last Update
December 1 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905