A Multi-Center Phase 2 Efficacy and Pharmacokinetic Study Evaluating Fludarabine, Cyclophosphamide, and Subcutaneous Campath (FCCam, Alemtuzumab) for Previously Untreated B-Cell Chronic Lymphocytic Leukemia
The primary objective of this study was to evaluate the safety and efficacy of the combination of fludarabine and cyclophosphamide in previously untreated CLL patients. Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day cycles.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Alemtuzumab
- drug : Cytoxan
- drug : Fludarabine
Phase: Phase 2
Ages Eligible For Study:
- ? age 18 - Karnofsky performance status 60% or above - Confirmed immunohistological diagnosis of Chronic Lymphocytic Leukemia (CLL) - Rai Stage I to IV as follows: - Advanced stage disease (Rai Stage III or IV, or modified Rai High Risk) - OR - Patients with Rai Stage I - II or (Modified Rai Intermediate-Risk) disease must have an indication for therapy based on 1996 NCI revised criteria for active disease as follows: - Any one of the following disease-related symptoms: 1. Weight loss ? 10% body weight within the previous 6 months 2. Extreme fatigue 3. Fever greater than 100.5° F for ? 2 weeks without evidence of infection 4. Night sweats without evidence of infection - Evidence of progressive marrow failure based on the development of worsening of anemia or thrombocytopenia - Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy - Massive (> 6 cm below the left costal margin) or progressive splenomegaly - Bulky (>10 cm in cluster) or progressive lymphadenopathy - Progressive lymphocytosis > 50% increase over 2 months, or anticipated doubling time < 6 months - Patients with immunoglobulin VH gene in unmutated nucleotide sequence configuration, as defined by ? 98% homology with the nearest germline counterpart - Serum creatinine ? 2x the upper limit of normal - Total serum bilirubin ? 2x the upper limit of normal. - AST ? 2x the upper limit of normal. - ALT ? 2x the upper limit of normal. - Signed written informed consent