Phase II Study of Campath-1H (NSC #950010) and Peripheral Blood Stem Cell Transplant for Patients With Chronic Lymphocytic Leukemia

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of chronic lymphocytic leukemia (CLL) that meets the following criteria at
any point prior to study entry:

- Peripheral blood absolute blood count greater than 5,000/mm^3

- Lymphocytosis must comprise small to moderate size lymphocytes with no more than
55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically

- Phenotypically characterized B-cell CLL

- Splenomegaly, hepatomegaly, or lymphadenopathy not required for CLL diagnosis

- Must have bone marrow biopsy within 4 weeks of study entry showing cellularity of at
least 25% of intratrabecular space and lymphocytes accounting for no more than 30% of
nucleated cells

PATIENT CHARACTERISTICS:

Age:

- 18 to 65

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

- Absolute neutrophil count at least 1,000/mm^3

- Hemoglobin at least 11 g/dL

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 2 mg/dL (unless secondary to tumor)

- AST or ALT less than 3 times upper limit of normal

- Hepatitis B surface antigen negative

- Hepatitis C RNA negative

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- Left ventricular ejection fraction at least 45% by echocardiogram or MUGA

Pulmonary:

- DLCO, FEV_1, and FVC greater than 50% of predicted

Other:

- No active infection requiring oral or IV antibiotics

- No other prior malignancy within the past two years except basal cell skin cancer or
carcinoma in situ of the cervix

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Prior monoclonal antibody CD52 allowed if at least partial remission was achieved
with last treatment

Chemotherapy:

- No more than 2 prior chemotherapy regimens

- At least 3 weeks since prior chemotherapy

- No more than 8 courses of prior fludarabine therapy

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified