asp:Content ID="Content1" ContentPlaceHolderID="ContentPlaceHolder1" Runat="Server">
National Cancer Institute - U.S. National Institutes of Health - www.cancer.gov
National Cancer Institute - U.S. National Institutes of Health - www.cancer.gov

Clinical Trial Spotlight
Leukemia – NCI-05-C-0185

Dr. John E. Janik
Principal Investigator

NCI is currently conducting the following trial for patients with T-cell leukemia or lymphoma. Click on the trial below for additional details, including a summary of eligibility criteria, treatment plan, and information on how to contact Dr. Janik and his staff directly.

You may also call the Clinical Trials Referral Office at 1-888-NCI-1937 (1-888-624-1937) to inquire about referring a patient to this trial.

Phase II Study of the Efficacy and Toxicity of OntakĀ® (Denileukin Diftitox) in the Therapy of Adult T-Cell Leukemia
NCI-05-C-0185

  • 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

Why is this trial important?

ATL is an aggressive T-cell lymphoproliferative disorder characterized by the presence of malignant CD4/CD25-expressing T cells in the peripheral blood, lymph nodes and other tissues. The various combination chemotherapies so far developed have not increased significantly the survival of patients with ATL. New approaches to treatment are needed and CD25 presents an attractive target for therapy. This fusion molecule delivers diphtheria toxin to the cancer cells because of their expression of CD25 which the interleukin-2 molecule binds to and is internalized.

Back to Top
Health and Human Services National Institutes of Health National Cancer Institute USA.gov National Cancer Institute Clinical Trials at NIH - Be part of the cure