• Return to search results
• Start new search

Investigator(s):
John E. Janik, M.D. Principal Investigator Phone: 301-402-2913 janikj@mail.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

---

Primary Eligibility:

• Age 18 and over
• Histologically confirmed Tac-expressing adult T-cell leukemia/lymphoma (ATL)
• Stages allowed include chronic, lymphomatous, or acute ATL
• HTLV-1 antibody positive; > 10% of malignant cells must express CD25
• Measurable disease, defined as > 10% abnormal (i.e., TAC homogenous strongly expressing) peripheral blood mononuclear cells
• No smoldering ATL
• Granulocyte count ≥ 1,000/mm³; platelet count ≥ 50,000/mm³; AST and ALT ≤ 2.5 times upper limit of normal (ULN); bilirubin ≤ 3.0 mg/dL; albumin ≥ 2.5 g/dL; creatinine < 2.0 mg/dL
• No symptomatic leukemic meningitis; no prior denileukin diftitox; no concurrent monoclonal antibodies; no concurrent gammaglobulin
• No myocardial infarction within the past 6 months; no severe coronary artery disease

---

Treatment Plan:

• Patients receive denileukin diftitox intravenously over 1 hour on Days 1-5
• Treatment repeats every 14 days for up to 24 courses in the absence of disease progression or unacceptable toxicity
• Patients achieving a complete response (CR) receive 2 additional courses of treatment beyond CR
• After completion of therapy, patients are followed at 4 weeks, every 1-3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter

---

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: 1/28/09