NCT04185220View on ClinicalTrials.gov

Phase I Study of Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for People With Refractory or Relapsed Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

February 26, 2020

Primary Completion Date

November 6, 2020

Study Completion Date

May 18, 2022

Conditions
Adult T-Cell Lymphoma/LeukemiaSezary SyndromeMycosis Fungoides
Interventions
DRUG

Recombinant human Interleukin-15 (rhIL-15)

Interleukin 15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation 3 + 3 system with a starting dose of 2 mcg/kg/day and a second dose level of 4 mcg/kg/day on days 1-5 of each of six cycles.

BIOLOGICAL

Mogamulizumab

Mogamulizumab (intravenous (IV) over at least 1 hour) will be administered at a dose of 1 mg/kg on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle. Treatment will continue for a maximum of 6 cycles.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT04185220 - Phase I Study of Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for People With Refractory or Relapsed Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome | Biotech Hunter | Biotech Hunter