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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
City of Hope Medical Center
Study ID
NCT04930653
Phase
PHASE2
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Extracorporeal Photopheresis — PROCEDURE
    Undergo ECP
  • Mogamulizumab — BIOLOGICAL
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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).

Key Dates

Start date
Oct 19, 2022
Status verified
Oct 2025
Primary completion
Jun 15, 2028
Completion
Jun 15, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ECP, mogamulizumab)
    Patients receive mogamulizumab 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 CR)/PR after 6 cycles receive up to 6 additional cycles of treatment in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Up to 1 year post treatment ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo ClinicScottsdaleArizona85259
Aaron Mangold, MD
[email protected]
480-301-8484
City of Hope Medical CenterDuarteCalifornia91010
Christiane R. Querfeld
[email protected]
626-218-5822
Christiane R. Querfeld (PRINCIPAL_INVESTIGATOR)
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322
Pamela Allen, MD
[email protected]
404-778-6195

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By research site
Mayo Clinic· Scottsdale, AZCity of Hope Medical Center· Duarte, CAWinship Cancer Institute of Emory University· Atlanta, GA

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