Phase 2 Fludarabine, Cytoxan and FCCAM <Alemtuzumab> in Untreated B-Cell Chronic Lymphocytic Leukemia
Leukemia, B-cell Leukemia, Chronic Leukemia
About this trial
This is an interventional treatment trial for Leukemia
Eligibility Criteria
Inclusion Criteria: ≥ 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: Weight loss ≥ 10% body weight within the previous 6 months Extreme fatigue Fever greater than 100.5° F for ≥ 2 weeks without evidence of infection 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 Exclusion Criteria: Prior pharmacological treatment for CLL Past history of anaphylaxis following exposure to monoclonal antibodies Active secondary malignancy or a history of malignant disease (other than CLL or non-melanoma skin cancer) within the preceding 5 years Any medical condition requiring systemic corticosteroids Active systemic infection Major systemic or other illness (including Coombs positivity and active hemolysis) that would, in the opinion of the investigator, interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results HIV positive by serologic testing Pregnant or nursing female Unwilling/unable to practice an acceptable form of contraception.
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Experimental
Fludarabine, cytoxan, then alemtuzumab
Fludarabine and cyclophosphamide days 1 to 3 for six 28-day cycles. Minimal residual disease positive responders continued on-treatment to receive alemtuzumab 30 mg weekly. MRD negative responders were observed.