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Investigator(s):
Robert J. Kreitman, M.D. Principal Investigator Phone: 301-496-6947 kreitmar@mail.nih.gov
Referral Contact(s):
Linda Ellison, R.N. Research Nurse Phone: 301-496-9458 Fax: 240-220-7677 ellisonl@mail.nih.gov	Rita Mincemoyer, R.N. Research Nurse Phone: 301-594-1778 Fax: 240-220-7677 mincemor@mail.nih.gov	Elizabeth Maestri, R.N. Research Nurse Phone: 301-402-5633 Fax: 240-220-7677 maestrie@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed hairy cell leukemia
• CD-22 positive disease by fluorescence-activated cell sorting with anti-CD22 antibody
• Meets at least 1 of the following indications for treatment:
• Absolute neutrophil count less than 1,000/mm³
• Hemoglobin less than 10g/dl
• Platelet count less than 100,000/mm³
• Absolute lymphocyte count greater than 20,000/mm³
• Symptomatic splenomegaly
• Meets one of the following response criteria:
• No response
• No complete response (CR) or partial remission (PR) less than 2 years in duration after the last course of prior cladribine
• CR or PR less than 4 years in duration after a second or later course of prior cladribine

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Treatment Plan:

• Dose-escalation study
• Patients are stratified according to remission duration after the last course of prior cladribine
• Patients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 followed by rest
• Patients are then evaluated at 8 weeks; patients achieving complete hematologic remission are followed; all other patients continue to receive BL22 immunotoxin as above on days 1, 3, and 5

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/18/08
Updated: 4/3/07