Adult T-cell leukemia/lymphoma (ATLL) and mycosis fungoides/Sezary syndrome (MF/SS) are cancers that form in the T cells, a type of white blood cell that helps with the body s immune response. A combination of drugs might be able to better treat these cancers than existing therapies.
To test if the drugs IL-15 and mogamulizumab are safe and effective to treat people with ATLL or MF/SS.
People ages 18 and older with relapsed ATLL or MF/SS that has not responded to at least one standard treatment
Participants will be screened with:
Blood (including HIV, hepatitis B and C), urine, lung, and heart tests
Bone marrow tests (if needed): A needle inserted in the participant s hip will take a small amount of marrow.
CT, PET and/or MRI scans
Tumor biopsy (if needed): A needle will take out a small piece of the participant s tumor.
Participants will get the study drugs by vein for up to six 28-day cycles. They will get IL-15 the first 5 days of each cycle. They will get mogamulizumab on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of the other cycles. They will be hospitalized for 1 week in cycle
Participants will have repeats of the screening tests throughout the study.
After treatment, participants will have visits every 60 days for 6 months, every 90 days for 2 years, and then every 6 months for 2 years.
-To determine the safety and toxicity profile and the maximum tolerated dose (MTD) of continuous intravenous infusion (civ) rhIL-15 administration in combination with standard intravenous (IV) mogamulizumab treatment
|Clinical Study Identifier||NCT04185220|
|Sponsor||National Cancer Institute (NCI)|
|Last Modified on||17 January 2021|
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