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Home > "P" Clinical Trials Conditions > Phase I Study of BL22, A Recombinant Immunotoxin for Chronic Lymphocytic Leukemia and CD22+ Lymphomas  Phase I Study of BL22, A Recombinant Immunotoxin for Chronic Lymphocytic Leukemia and CD22+ Lymphomas
Phase I Study of BL22, A Recombinant Immunotoxin for Chronic Lymphocytic Leukemia and CD22+ Lymphomas
For Condition: Lymphoma,Chronic Lymphocytic Leukemia,B Cell Leukemia
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will evaluate the safety of BL22 in patients with certain lymphomas or leukemias. The lymphoma or leukemia cells have a protein on their surface called CD22, and BL22 is able to kill CD22-containing cells in culture (outside the body). BL22 is an immunotoxin, which is a drug that contains a part that binds to a cell (an antibody called RFB4) and a part that kills a cell (a toxin called PE38). This study will determine whether BL22 will carry the toxin to sites of cancer and selectively kill the tumor cells. The purpose of this study is to determine how much BL22 can safely be given to humans and how long it lasts in the bloodstream. The first group of patients will be treated with low doses, and subsequent patients will receive higher doses if the drugs appears safe. Patients will receive BL22 as inpatients at the NIH Clinical Center every other day, for a total of 3 doses. They will be discharged on day 8. On day 11 and again a week later, blood work will be done. A month after beginning treatment, a CAT scan and other tests will be conducted. Depending on those results, patients may be eligible for additional dose cycles of BL22. Each cycle includes a set of 3 doses. Only adult patients who cannot be cured with standard treatment are eligible for this study. Experience with BL22 is limited in humans. Risks include a potentially fatal condition in which platelets clot in the kidneys, kidney and liver damage, brain clotting, fluid leaking from blood vessels, and other less serious complications.
Details: The purpose of the study is to evaluate the toxicity following administration of the recombinant immunotoxin BL22 in patients with CD22-positive malignancies (e.g. B-cell non-Hodgkin's lymphomas, chronic lymphocytic leukemia, and prolymphocytic leukemia). The scientific basis for the proposed therapeutic study is that patients with these malignancies have cells which express high levels of the CD22 antigen on their cell surface. We propose to administer the immunotoxin BL22 to adult patients with CD22+ malignancies who fulfill the patient eligibility criteria. Patients will be followed closely for evidence of clinical or laboratory toxicity. Clinical response will be evaluated using routine hematologic and clinical evaluation and, when deemed appropriate by the Principal Investigator, by monitoring the phenotype of circulating B-cells or of biopsied tissues using antibodies to CD22. Serum concentrations of the administered immunotoxin and levels of anti-immunotoxin antibodies produced by the patients will also be monitored. In a later phase of this trial, only patients without hairy cell leukemia will be enrolled, and patients with hairy cell leukemia may be eligible for a different phase I trial of BL22.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 40
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Clinical Support Center/NCI 1-888-624-1937
Additional Information:
Study ID Numbers: 010213; 01-C-0213
Study Start Date: July 23, 2001
Record last reviewed: May 10, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021593
Other Lymphoma Studies:
1. Phase I Study of BL22, A Recombinant Immunotoxin for Chronic Lymphocytic Leukemia and CD22+ Lymphomas
Related Studies:
Other Lymphoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Phase I Study of BL22, A Recombinant Immunotoxin for Chronic Lymphocytic Leukemia and CD22+ Lymphomas
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