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Investigator(s):
John C. Morris, M.D. Principal Investigator Phone: 301-402-2912 jmorris@mail.nih.gov	Thomas Waldmann, M.D. Protocol Chair Phone: 301-496-6656 tawald@helix.nih.gov
Referral Contact(s):
Debbie Draper, R.N., B.S.N. Research Nurse Phone: 301-435-8525 draperde@mail.nih.gov	Suzanne Fioravanti, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-594-6544 Fax: 301-402-1001 fioravas@mail.nih.gov

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Primary Eligibility:

• Histologically or cytologically confirmed T-cell large granular lymphocytic (T-LGL) leukemia
• T-LGL-associated hemocytopenia
• No symptomatic CNS involvement by leukemia
• ≥ 4 weeks since prior interferon, chemotherapy, and/or cyclosporine
• No NY Heart Association class III or IV CHF

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Study Outline:

• Patients will receive monoclonal antibody Mik-beta-1 intravenously over 90 minutes on Day 1 followed by monitoring for side effects, blood levels of the antibody, receptor saturation with the antibody, serum chemistries and blood counts for 6 weeks
• Cohorts of 3-6 patients will receive escalating doses of monoclonal antibody Mik-beta-1 until the maximum tolerated dose (MTD) is determined
• Patients will be followed weekly for 6 weeks and then every 3 months for 9 months

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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: 8/25/09
Updated: 7/29/09