Expired Study
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Bethesda, Maryland 20892


RATIONALE: BL22 immunotoxin can find tumor cells and kill them without harming normal cells. PURPOSE: This phase I trial is studying the side effects and best dose of BL22 immunotoxin in treating patients with refractory B-cell chronic lymphocytic leukemia, prolymphocytic leukemia, or non-Hodgkin's lymphoma.

Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of recombinant BL22 immunotoxin in patients with CD22-positive refractory B-cell chronic lymphocytic leukemia, prolymphocytic leukemia, or indolent non-Hodgkin's lymphoma. - Determine the safety and efficacy of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine the immunogenicity of this drug in these patients. - Determine the effect of this drug on various components of the circulating cellular immune system in these patients. OUTLINE: This is a nonrandomized, dose-escalation study. Patients are stratified according to disease type (chronic lymphocytic leukemia vs non-Hodgkin's lymphoma). Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats ≥ every 27 days for up to 6 courses in the absence of neutralizing antibodies to BL22 or PE38, disease progression, or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients who relapse from a CR lasting ≥ 6 months may receive additional courses. Cohorts of 3-6 patients per stratum receive escalating doses of recombinant BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 24 patients (12 per stratum) will be accrued for this study within 1-2 years.


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



Primary Contact:

Principal Investigator
Robert Kreitman, MD
National Cancer Institute (NCI)

Backup Contact:


Location Contact:

Bethesda, Maryland 20892
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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