INCLUSION CRITERIA:
All newly enrolled patients must have a confirmed diagnosis of B-cell leukemia or lymphoma, non-HCL.
Patients must have evidence of CD22 positivity by the following criteria:
Greater than 15% of malignant cells from a site must react with anti-CD22 by immunohistochemistry or
Greater than 30% of malignant cells from a site CD22+ by FACS or
Greater than 400 CD22 sites/cell (average) on malignant cells as assessed by radiolabeled anti-CD22 binding.
Stage of Disease:
NHL: Patients with all histopathologic subtypes of CD22+ B-cell non-Hodgkin's lymphoma (NHL) are eligible. Patients with indolent NHL stages II through IV are eligible if they have failed at least one standard therapy and if treatment is medically indicated. Patients with aggressive NHL are eligible if they have relapsed after standard chemotherapy and either are not eligible for or have refused salvage chemotherapy or bone marrow transplantation.
CLL: Patients with chronic lymphocytic leukemia (CLL) and prolymphocytic leukemia (PLL) are eligible if they have failed standard chemotherapy and if treatment is medically indicated.
Patients will not be ineligible because of prior bone marrow transplantation. Medical indications for treatment include progressive disease-related symptoms, progressive cytopenias due to marrow involvement, progressive or painful splenomegaly or adenopathy, rapidly increasing lymphocytosis, autoimmune hemolytic anemia or thrombocytopenia and increased frequency of infections.
Patients must have a Karnofsky performance status of at least 60.
Patients must be able to understand and sign informed consent.
Omission of cytotoxic chemotherapy, whole body electron beam radiation therapy, interferon, retinoids or other systemic therapy of the malignancy for 3 weeks prior to entry into the trial. Patients who have received or are receiving radiation therapy less than 3 weeks prior to study entry will be not be excluded providing the volume of bone marrow treated is less than 10 percent and also the patient has measurable disease outside the radiation port.
Patients must have a life expectancy of greater than 6 months.
Patients must be at least 18 years old.
The transaminases ALT and AST must each be less than 5-times the upper limits of normal.
If serum creatinine is greater than 2.0 mg/dL, then a measured 24-hour creatinine clearance must be greater than 50 mL/min.
If the patient is non-leukemic, the ANC must be greater than 1000/cmm and the platelet count greater than 40,000/cmm. Patients with leukemia may be treated regardless of the ANC. A patient will not be excluded because of pancytopenia if it is due to disease, based on the results of bone marrow studies.
Patients with pulmonary or mediastinal involvement with tumor to greater than 1/3 of total of thoracic diameter must have greater than 50% of predicted pulmonary function in terms of forced expiratory volume (FEV1, total lung capacity (TLC) and diffusing capacity for carbon monoxide (DLCO), as assessed by pulmonary function studies.
Patients with childbearing potential are required to practice contraception during the study.
EXCLUSION CRITERIA:
Female patients of child-bearing potential will be tested for pregnancy by urine obtained during the week before beginning BL22; pregnant patients will be excluded from the study due to unknown effects of BL22 on the fetus. Breast feeding women will be excluded from the study because it is not known whether BL22 would cause adverse effects on the baby and/or mother in this situation.
Patients who are HIV-antibody positive, due to the difficulty in separating drug-related toxicity from HIV-related problems in such patients.
Patients with central nervous system disease who require treatment.
Patients whose serum neutralizes BL22 or PE38 in tissue culture, due either to anti-toxin or anti-mouse-IgG antibodies. No patient whose serum neutralizes greater than 75% of the activity of 1 µ (Micro)g/mL of BL22 will be treated. Guidelines more strict than this may be used at the discretion of the principal investigator. This criteria shall apply for patients to be retreated with one exception. If a patient achieves a peak plasma level during the prior cycle of greater than 1 microgram/ml and develops antibodies which neutralize greater than 75 percent of the activity of 1 microgram/ml but greater than 50 percent of the activity of a concentration of BL22 which is less than the previous peak plasma level, that patient would not be disqualified from retreatment due to immunogenicity. Due to the low rate of immunogenicity in patients treated with BL22, retreatment of patients need not be delayed if the results of neutralizing antibody tests are unexpectedly unavailable and the test is pending.
Diagnosis of hairy cell leukemia.
Warren Grant Magnuson Clinical Center (CC)