A Multi-Center Phase II Efficacy and Pharmacokinetic Study Evaluating Fludarabine, Cyclophosphamide, and Subcutaneous Campath (FCCam) for Previously Untreated B-Cell Chronic Lymphocytic Leukemia
- Male or female, age 18 or older, with a confirmed immunohistological diagnosis of CLL
- Signed written informed consent
- Karnofsky performance status 60% or above (Appendix E)
- Advanced stage disease (Rai Stage III or IV, or modified Rai High Risk).
- 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
- Any one of the following disease-related symptoms:
1. Weight loss >= 10% 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
- 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, regardless of
- Serum creatinine <= 2x the upper limit of normal. Total serum bilirubin, AST, and
ALT: <= 2x the upper limit of normal.
- Prior pharmacological treatment for CLL.
- Any medical condition requiring systemic corticosteroids.
- Active systemic infection.
- HIV positive by serologic testing.
- 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.
- Pregnant or nursing women, or unwilling/unable to practice an acceptable form of
contraception. Treatment with the study agents would expose an unborn child to
- 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.