Clinical Trial: Subcutaneous Recombinant Human IL-15 (s.c. rhIL-15) and Alemtuzumab for People With Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional



Official Title: A Phase I Study Of Subcutaneous Recombinant Human IL-15 (S.C.rhIL-15) and Alemtuzumab for Patients With Refractory or Relapsed Chronic and Acute Adult T-Cell Leukemia (ATL

Brief Summary:

Background:

Adult T-cell leukemia (ATL) is a rare blood cancer. Researchers want to see if a combination of two drugs - recombinant human interleukin 15 (rhIL-15) and alemtuzumab - is a better treatment for ATL.

Objectives:

To test if giving rhIL-15 combined with alemtuzumab improves the outcome of therapy for ATL. Also, to determine the safe dose of this combination and identify side effects and effects on the immune system.

Eligibility:

Adults 18 years and older with chronic or acute ATL who have not been helped by other treatments.

Design:

Participants will be screened with tests that are mostly part of their usual cancer care. They will sign a separate consent form for this.

Weeks 1 and 2: Participants will have a total of 10 visits. They will:

  • Get rhIL-15 under the skin by needle.
  • Have a physical exam and vital signs measured.
  • Give blood samples.
  • Answer questions about their health and their medicines.

Week 3: Participants will stay in the clinic. They will:

  • Get alemtuzumab infusions in a vein through a small catheter on days 1, 2, 3, and 5..
  • Take medicines to decrease side effects.
  • Have a computed tomography (CT) scan to evaluate the