A Phase II Study of Fludarabine Induction Followed by CAMPATH-1H Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia

Inclusion Criteria

DISEASE CHARACTERISTICS: Previously untreated, stage I, II, III, or IV B-cell chronic
lymphocytic leukemia (CLL) Lymphocytosis greater than 5,000/mm3 with less than 55%
prolymphocytes Bone marrow aspirate with greater than 30% of all nucleated cells being
lymphoid OR Bone marrow core biopsy must show lymphoid infiltrates compatible with marrow
involvement by CLL Overall cellularity must be normocellular or hypercellular Monoclonal
B-cell population positive for at least 1 B-lineage marker (CD19, CD20, CD23, CD24) with
coexpression of CD5 Bright surface immunoglobulin levels must have CD23 coexpression Stage
I or II disease must have evidence of active disease demonstrated by at least 1 of the
following: Massive or progressive splenomegaly and/or lymphadenopathy Presence of weight
loss greater than 10% over the preceding 6-month period Grade 2 or 3 fatigue Fevers
greater than 100.5 degrees Fahrenheit or night sweats for greater than 2 weeks without
evidence of infection Progressive lymphocytosis with an increase of greater than 50% over
a 2-month period or an anticipated doubling time of less than 6 months

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Life expectancy: Not
specified Hematopoietic: Direct Coomb's test negative Hepatic: Not specified Renal:
Creatinine no greater than 1.5 times upper limit of normal Other: Not pregnant or nursing
Fertile patients must use effective contraception No medical condition requiring chronic
oral corticosteroids

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for CLL No
concurrent epoetin alfa Chemotherapy: No prior chemotherapy for CLL No other concurrent
chemotherapy Endocrine therapy: No prior corticosteroids for autoimmune complications that
have developed since initial diagnosis of CLL No concurrent hormones except steroids for
new adrenal failure or nondisease-related conditions (e.g., insulin for diabetes) No
concurrent dexamethasone or other corticosteroid-based antiemetics Radiotherapy: No
concurrent palliative radiotherapy Surgery: Not specified