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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 chronic lymphocytic leukemia, including prolymphocytic leukemia
• CD25-positive disease
  • At least 50% of peripheral malignant lymphocytes are CD25+ by fluorescence-activated cell sorting (FACS) with anti-CD25 antibody* NOTE: *Positive expression in FACS assay is defined as > 2 times the mean fluorescence intensity of the control antibody by FACS
• Intermediate- or high-risk disease, meeting the following criteria:
  • Lymphocytosis (leukemic cells > 5,000/mm) AND has at least one of the following:
    • Lymphadenopathy
    • Splenomegaly
    • Hepatomegaly
    • Anemia (hemoglobin < 11g/dL)
    • Thrombocytopenia (platelet count < 100,000/mm³)
• Progressive disease after prior standard therapy containing either a purine analog or an alkylating agent
• No serum neutralizing LMB-2 immunotoxin in tissue culture (due to either anti-toxin or anti-mouse-immunoglobulin G antibodies)
• No serum neutralizing > 75% of the activity of 1 μg/mL of LMB-2 immunotoxin
• 18 and over
• ECOG 0-2
• ALT and AST ≤ 2.5 times upper limit of normal (ULN), albumin ≥ 3.0 g/dL, bilirubin ≤ 2.2 mg/dL (< 5 mg/dL in patients with Gilbert's syndrome), hepatitis B surface antigen negative unless patient is receiving treatment with lamivudine, no hepatitis C, no chronic liver disease
• Creatinine ≤ 1.4 mg/dL OR Creatinine clearance ≥ 50 mL/min
• LVEF ≥ lower limit of normal, no symptomatic congestive heart failure, no unstable angina pectoris, no cardiac arrhythmia
• DLCO ≥ 55% of normal, FEV_1 ≥ 60% of normal
• HIV negative, no ongoing or active infection
• No other concurrent uncontrolled illness

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Treatment Plan:

• Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1, 3, and 5
• Treatment repeats every 28 days for up to 6 courses in the absence of disease progression, neutralizing antibodies (i.e., > 75% of the activity of 1μg/mL of LMB-2 immunotoxin), or unacceptable toxicity
• Patients who achieve a complete response receive up to 2 additional courses of LMB-2 immunotoxin
• Patients who relapse after achieving a complete or partial response for more than 2 months are eligible for retreatment as described above
• Patients are followed every 3-12 months until disease progression

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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: 12/13/07