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).
PRIMARY OBJECTIVE: I. To assess tolerability and overall response rate (ORR) of the (ECP)/mogamulizumab regimen in CTCL patients previously untreated with mogamulizumab. SECONDARY OBJECTIVES: 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 ECP/mogamulizumab combination. II. To summarize the toxicities in CTCL patients treated with the ECP/mogamulizumab combination. EXPLORATORY OBJECTIVES: 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. OUTLINE: 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 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Undergo ECP
Given IV
Ancillary studies
Ancillary studies
Mayo Clinic
Scottsdale, Arizona, United States
RECRUITINGCity of Hope Medical Center
Duarte, California, United States
RECRUITINGWinship Cancer Institute of Emory University
Atlanta, Georgia, United States
RECRUITINGOverall response rate (ORR)
ORR will be calculated as the proportion of evaluable patients that have confirmed complete response (CR) or partial response (PR), as defined according to global response assessment. Exact 95% confidence intervals will be calculated for these estimates.
Time frame: Up to 1 year post treatment
Incidence of adverse events
Toxicity and adverse events will be recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events 5.0 scale. Observed toxicities will be summarized by type, severity, date of onset, and attribution.
Time frame: Up to cycle 3 (each cycle = 28 days)
Complete response rate
Defined as the proportion of response-evaluable patients that have a documented CR.
Time frame: Up to 1 year post treatment
Time to response
Will be estimated using the product-limit method of Kaplan and Meier.
Time frame: From initiation of study therapy to the first achievement of CR or PR, assessed up to 1 year
Duration of response
Will be estimated using the product-limit method of Kaplan and Meier.
Time frame: From the first achievement of PR or CR to time of partial disease or death, assessed up to 1 year
Progression-free survival
Will be estimated using the product-limit method of Kaplan and Meier.
Time frame: From initiation of study therapy to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed up to 1 year
Overall survival
Will be estimated using the product-limit method of Kaplan and Meier.
Time frame: From initiation of study therapy to death from any cause, assessed up to 1 year
Incidence of adverse events
Toxicity and adverse events will be recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events 5.0 scale. Observed toxicities will be summarized by type, severity, date of onset, and attribution.
Time frame: Up to 30 days post treatment
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