NCT04930653

Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma

A Phase II Study of Combination Extracorporeal Photopheresis (ECP) and Mogamulizumab in Erythrodermic CTCL

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• 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

Interventions

Type	Name	Description
PROCEDURE	Extracorporeal Photopheresis	Undergo ECP
BIOLOGICAL	Mogamulizumab	Given IV
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2022-10-19
• Primary completion: 2028-06-15
• Completion: 2028-06-15
• First posted: 2021-06-18
• Last updated: 2025-10-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study