This phase I trial studies the side effects and best dose of recombinant human interleukin-15 when given together with alemtuzumab in treating patients with chronic or acute adult T-cell leukemia that does not response to treatment (refractory) or has come back (recurrent). Interleukins, such as recombinant human interleukin-15, are proteins made by white blood cells and other cells in the body and may help regulate immune response. Immunotherapy with monoclonal antibodies, such as alemtuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving recombinant human interleukin-15 and alemtuzumab may work better in treating patients with chronic or acute adult T-cell leukemia.
Additional locations may be listed on ClinicalTrials.gov for NCT02689453.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Determine the safety, toxicity profile and the maximum tolerated dose (MTD) of subcutaneous recombinant human interleukin-15 (s.c. rhIL-15) administered in combination with standard three times per week intravenous (IV) alemtuzumab treatment.
SECONDARY OBJECTIVES:
I. Evaluate the potential anti-tumor activity of the combination of rhIL-15 and alemtuzumab assessing the clinical response rate and progression free survival.
II. Characterize the biological effects of rhIL-15 administered with alemtuzumab on the percentages and absolute numbers of circulating lymphocytes (T and natural killer [NK] cells) and the T-cell subsets naive, central and effector memory subsets (based on expression of CD52, CD56, CD4, CD8, CD45RO, CD45RA, CD28, CD95, CD194, CCR7 and CD62L) by flow cytometry.
III. Define the effect of the combination on the plasma levels of pro-inflammatory cytokines.
OUTLINE: This is a dose-escalation study of recombinant human interleukin-15.
Patients receive recombinant human interleukin-15 SC once daily (QD) 5 days per week for 2 weeks (10 doses) and alemtuzumab IV over 2-12 hours on days 1, 2, 3, and 5 of week 3 and 3 times a week on weeks 4, 5, and 6.
After completion of study treatment, patients are followed up every 60 days for 6 months and then every 90 days for up to 2 years.
Lead OrganizationNCI - Center for Cancer Research
Principal InvestigatorKevin C. Conlon