Status:
COMPLETED
Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
B-cell Chronic Lymphocytic Leukemia
Stage I Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well giving fludarabine together with rituximab followed by alemtuzumab works in treating patients with chronic lymphocytic leukemia. Monoclonal antibodies, such as...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the rate of complete response and toxicity of concurrent treatment with fludarabine and rituximab followed by consolidative alemtuzumab in patients with previously...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Specific Diagnosis of B-Cell CLL
- An absolute lymphocytosis of \> 5,000/μL
- Morphologically, the lymphocytes must appear mature with \< 55% prolymphocytes
- Bone marrow examination must include at least a unilateral aspirate and biopsy; the aspirate smear must show \> 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL; the overall cellularity must be normocellular or hypercellular
- Local institution lymphocyte phenotype must reveal a predominant B-cell monoclonal population sharing a B-cell marker (CD19, CD20, CD23) with the CD5 antigen, in the absence of other pan-T-cell markers; additionally, the B-cells must be monoclonal with regard to expression of either κ or λ and have surface immunoglobulin expression of low density; patients with bright surface immunoglobulin levels must have CD23 co-expression
- Patients must be in the intermediate- or high-risk categories of the modified three-stage Rai staging system (i.e., stages I, II, III, or IV)
- Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria:
- Massive or progressive splenomegaly, hepatomegaly and/or lymphadenopathy;
- Presence of weight loss \> 10% over the preceding 6 month period;
- Grade 2 or 3 fatigue;
- Fevers \> 100.5°F or night sweats for greater than 2 weeks without evidence of infection;
- Progressive lymphocytosis with an increase of \> 50% over a 2 month period or an anticipated doubling time of less than 6 months
- No prior therapy for CLL including corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL
- No medical condition requiring chronic use of oral corticosteroids
- Performance Status 0 - 2
- Due to alterations in host immunity, patients with HIV may not be enrolled
- Due to the unknown teratogenic potential of alemtuzumab, pregnant or nursing women may not be enrolled; women and men of reproductive potential should agree to use an effective means of birth control
- Creatinine =\< 1.5 x upper limit of institutional normal value
- Coomb's Testing NEGATIVE
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00098670
Start Date
October 1 2004
End Date
February 1 2011
Last Update
May 21 2014
Active Locations (2)
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1
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
2
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210