Protocol Number: 05-C-0171
Patients 18 years of age and older with non-hairy cell leukemia or lymphoma may be eligible for this study. Their cancer cells must have the CD22 protein receptor. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram, bone marrow biopsy, and chest x-ray and imaging studies to evaluate the extent of disease. Participants undergo the following tests and procedures: -Drug therapy: Patients are admitted to the NIH Clinical Center for BL22 infusions through a vein (intravenous, or i.v.) at the beginning of each treatment cycle. A cycle consists of 3 doses of drug, given on days 1, 3 and 5, followed by at least 4 weeks off drug. To prevent kidney damage, patients receive i.v. fluid before and after each dose, each time over 2-4 hours. They also receive a slower infusion of about 2 pints per day during the first week of the treatment cycle. Patients who do well can be discharged from the hospital on day 8. -Blood tests: Blood is drawn frequently; up to a pint of blood may be collected every 6 weeks. For example, around the time of dosing on days 1, 3 and 5, about a teaspoon of blood is drawn 19 times to determine, in part, how BL22 is distributed in the body. On day 11 and again about a week later, patients have blood tests to monitor the effects of BL22 on the body's normal functions. Patients are monitored for anemia and given transfusions, if required. -CT scan: A CT scan and other tests are done about a month after beginning BL22 to determine the possible benefits and toxicity of the drug. Depending on their response to treatment, patients may be eligible for up to five additional cycles of BL22. Patients who develop severe toxicity to the drug, or whose immune system rejects the drug, or whose disease worsens with treatment may be taken off the study.
Search The Studies | Help | Questions |
National Institutes of Health Clinical Center |
||