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

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Primary Eligibility:

• Histopathologically confirmed hairy cell leukemia
• Relapsed or refractory disease
• Meets one of the following criteria:
• Received prior BL22 immunotoxin or LMB-2 immunotoxin AND did not have unacceptable toxicity
• Received prior anti-CD22 immunotoxin CAT-8015 on clinical trial NCI-07-C-0130 (CAT-8015-1001) AND had disease progression or relapse
• Considered to be off-study for CAT-8015-1001-specified follow-up
• No discontinuation from anti-CD22 immunotoxin CAT-8015 studies due to toxicity or dose-limiting toxicity
• Must have received ≥ 2 prior systemic therapies that included ≥ 2 courses of purine analog therapy (or 1 course of purine analog therapy if response to this course lasted < 2 years, or if patient experienced unacceptable toxicity to purine analog)
• Must have ≥ 1 of the following indications for treatment:
• Neutropenia (ANC < 1,000/mm³)
• Anemia (hemoglobin < 10 g/dL)
• Thrombocytopenia (platelet count < 100,000/mm³)
• Absolute lymphocyte count > 5,000/mm³
• Symptomatic splenomegaly
• Enlarging lymph nodes > 2 cm
• No antibody titer that neutralizes > 75% of the activity of 1 μg/mL of BL22 immunotoxin using a bioassay
• Recovered from prior therapy
• Concurrent radiotherapy allowed provided evaluable disease is present outside the radiotherapy port
• Concurrent surgery allowed
• ECOG 0–2 (unless due to reversible active, uncontrolled infection)
• ALT and AST ≤ 2.5 x upper limit of normal
• Albumin ≥ 3 g/dL
• Total bilirubin ≤ 2.2 mg/dL
• Creatinine ≤ 1.4 mg/dL OR creatinine clearance ≥ 50 mL/min
• Not pregnant or nursing; fertile patients must use effective contraception
• No medical condition that would preclude study participation

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Study Outline:

• Patients receive BL22 immunotoxin IV over 30 minutes on Days 1, 3, and 5
• Treatment repeats every 4 weeks for up to 16 courses in the absence of disease progression or unacceptable toxicity
• After completion of study therapy, patients are followed every 6 months for 1 year and then annually thereafter

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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: 
Updated: 6/4/09