BL22 Immunotoxin in Treating Patients With Refractory Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, or Non-Hodgkin's Lymphoma
Leukemia, Lymphoma
About this trial
This is an interventional treatment trial for Leukemia focused on measuring B-cell chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, recurrent marginal zone lymphoma, splenic marginal zone lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma, recurrent mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, recurrent adult diffuse small cleaved cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, Waldenstrom macroglobulinemia, prolymphocytic leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of B-cell leukemia or lymphoma of 1 of the following types: Chronic lymphocytic leukemia Failed standard chemotherapy Prolymphocytic leukemia Failed standard chemotherapy Indolent non-Hodgkin's lymphoma, including mantle cell lymphoma Stage III or IV disease Failed ≥ 1 prior doxorubicin- or fludarabine-containing standard therapy CD22-positive disease, as evidenced by 1 of the following: More than 15% malignant cells react with anti-CD22 by immunohistochemistry More than 30% malignant cells are CD22-positive by fluorescence-activated cell sorting analysis More than 400 CD22 sites per malignant cell (average) by radiolabeled anti-CD22 binding Treatment is medically indicated, as evidenced by any of the following: Progressive disease-related symptoms Progressive cytopenias due to marrow involvement Progressive or painful splenomegaly or adenopathy Rapidly increasing lymphocytosis Autoimmune hemolytic anemia or thrombocytopenia Increased frequency of infections No neutralizing anti-toxin or anti-mouse immunoglobulin G (IgG) antibodies to BL22 or PE38 No serum neutralization of > 75% of the activity of 1 μg/mL of BL22 No CNS disease requiring treatment No hairy cell leukemia PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 6 months Hematopoietic Absolute neutrophil count > 1,000/mm^3* Platelet count > 40,000/mm^3 NOTE: *Patients with leukemia are eligible regardless of absolute neutrophil count; Grade III-IV pancytopenia or growth factor dependence allowed if due to disease Hepatic Bilirubin < 1.5 times upper limit of normal (ULN) ALT and AST < 2.5 times ULN Renal Creatinine ≤ 1.5 mg/dL Pulmonary FEV1 ≥ 60% of predicted DLCO ≥ 55% of predicted Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy Prior bone marrow transplantation allowed More than 3 weeks since prior biologic therapy, including interferon, denileukin diftitox, or LMB-2 immunotoxin More than 3 months since prior monoclonal antibody therapy (e.g., rituximab) Chemotherapy See Disease Characteristics More than 3 weeks since prior cytotoxic chemotherapy Endocrine therapy More than 1 week since prior steriods Less than 5 doses for non-treatment reasons (e.g., allergy prophylaxis) No evidence of disease response Radiotherapy More than 3 weeks since prior whole-body electron beam radiotherapy Radiotherapy within the past 3 weeks allowed provided the volume of bone marrow treated is < 10% AND the patient has measurable disease located outside the radiation port Surgery Not specified Other More than 3 weeks since prior retinoids More than 3 weeks since other prior systemic therapy for this malignancy
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office