This phase II trial studies the effect of extracorporeal photopheresis (ECP) and
mogamulizumab in treating patients with erythrodermic cutaneous T cell lymphoma (CTCL), a
type of skin lymphoma. CTCL is a rare type of cancer that begins in the white blood cells
called T cells. Erythrodermic is a widespread red rash that may cover most of the body. ECP
is a medical treatment that removes blood with a machine, isolates white blood cells and
exposes them to ultra violet light, then returns the cells to the body. Mogamulizumab is a
monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
Giving mogamulizumab with ECP may work together to kill the tumor cells directly (with
mogamulizumab) and boost immune response to cancer (with ECP).
I. To assess tolerability and overall response rate (ORR) of the (ECP)/mogamulizumab regimen
in CTCL patients previously untreated with mogamulizumab.
I. To estimate complete response (CR) rate, time to response, duration of response,
progression free survival, and overall survival in CTCL patients treated with the
II. To summarize the toxicities in CTCL patients treated with the ECP/mogamulizumab
I. To assess quality of life (QoL) parameters before, during, and after the regimen.
II. To evaluate the anti-tumor and immunomodulatory effects of mogamulizumab in the CTCL
microenvironment in skin and blood samples of erythrodermic CTCL patients.
III. To evaluate the immunomodulatory effects of ECP.
Patients receive mogamulizumab intravenously (IV) over 60 minutes on days 1, 8, 15, 22, of
cycle 1 and days 1 and 15 of subsequent cycles. Beginning in cycle 2, patients also undergo
ECP over 3 hours on days 8, 9, 22,and 23. Treatment repeats every 28 days for up to 6 cycles
in the absence of disease progression or unacceptable toxicity. Patients achieving complete
response (CR)/partial response (PR) after 6 cycles receive up to 6 additional cycles of
treatment in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, then for up to 12
Folliculotropic Mycosis Fungoides, Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Sezary Syndrome, Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8, Transformed Mycosis Fungoides
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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