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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):
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 proven Tac-expressing adult T-cell leukemia/lymphoma (ATL)
• Smoldering or chronic stage ATL
• Measurable disease (defined as > 5% abnormal peripheral blood mononuclear cell)
• Normal lymphocyte count (< 4,000/mm³)
• No hypercalcemia, lymphadenopathy, malignant pleural effusion or ascites
• No symptomatic CNS disease due to ATL
• > 3 weeks since prior chemotherapy for ATL and no concurrent anticancer agents
• Age ≥ 10

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Treatment Plan:

Phase I (closed to accrual 6/11/2001)

Phase II (open to smoldering and chronic stage ATL only)

• Patients will receive daclizumab 8 mg/kg intravenously every 3 weeks
• Patients who achieve and maintain a complete or partial response to treatment after 6 courses in the absence of dose-limiting toxicity may continue to receive daclizumab for a total of 24 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: 6/28/08
Updated: 12/11/06