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

NCT04930653 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 20724NCI-2021-03533P30CA033572
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief 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).

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

Outcome Measures

Primary Outcomes (2)

• Overall 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.

  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.

  Up to cycle 3 (each cycle = 28 days)

Secondary Outcomes (6)

• Complete response rate

  Up to 1 year post treatment

• Time to response

  From initiation of study therapy to the first achievement of CR or PR, assessed up to 1 year

• Duration of response

  From the first achievement of PR or CR to time of partial disease or death, assessed up to 1 year

• Progression-free survival

  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

  From initiation of study therapy to death from any cause, assessed up to 1 year

Study Arms (1)

Treatment (ECP, mogamulizumab)

EXPERIMENTAL

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.

Procedure: Extracorporeal Photopheresis; Biological: Mogamulizumab; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Extracorporeal Photopheresis PROCEDURE

Undergo ECP

Also known as: Extracorporeal Photophoresis, photopheresis, Photophoresis

Treatment (ECP, mogamulizumab)

Mogamulizumab BIOLOGICAL

Given IV

Also known as: Immunoglobulin G1, Anti-(CC Chemokine Receptor CCR4) (Human-Mouse Monoclonal KW-0761 Heavy Chain), Disulfide With Human-Mouse Monoclonal KW-0761 Kappa-Chain, Dimer, KM8761, KW-0761, Mogamulizumab-kpkc, Poteligeo

Treatment (ECP, mogamulizumab)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (ECP, mogamulizumab)

Questionnaire Administration OTHER

Ancillary studies

Treatment (ECP, mogamulizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented informed consent of the participant and/or legally authorized representative
• Assent, when appropriate, will be obtained per institutional guideline
• Agreement to allow the use of archival tissue from diagnostic tumor biopsies
• If unavailable, exceptions may be granted with study principal investigator (PI) approval
• Age: \>= 18 years
• Eastern Cooperative Oncology Group (ECOG) =\< 2
• Histologically confirmed mycosis fungoides (MF) or Sezary syndrome (SS). Safety lead-in: \>= stage IIB OR \>= stage IB-IIA folliculotropic/transformed MF. Phase 2: \>= stage IB
• Stage of disease according to Tumor-Node-Metastasis-Blood (TNMB) classification
• Pathology report must be diagnostic or be consistent with MF/SS criteria
• SS is defined as meeting T4 plus B2 criteria; where the biopsy of erythrodermic skin may only reveal suggestive but not diagnostic histopathologic features, the diagnosis may be based on either node biopsy or fulfillment of B2 criteria
• For MF where the histological diagnosis by light microscopic examination is not confirmed, diagnostic criteria that been recommended by the International Society of Cutaneous Lymphomas (ISCL) should be used.
• Measurable disease per Modified Severity Weighted Assessment Tool (mSWAT) and/or Sezary count
• Baseline skin biopsy taken within 6 months available for central review submission
• Without bone marrow involvement: Absolute neutrophil count (ANC) \>= 1,500/mm\^3 (performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)
• NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement

You may not qualify if:

• Prior mogamulizumab
• Any systemic therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating protocol therapy
• Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy
• Any skin-directed therapy within 14 days prior to initiating protocol therapy
• Any radiation therapy within 21 days prior to initiating protocol therapy
• Immunosuppressive medication within 14 days prior to the first dose of study treatment. The following are exceptions to this criterion:
• Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection) and are on stable dose for at least 28 days
• Systemic corticosteroids at physiologic doses of \< 10 mg/day of prednisone or equivalent
• Live, attenuated vaccine within 30 days prior to the first dose protocol therapy
• Disease free of prior malignancies for \>= 5 years with the exception of:
• Currently treated squamous cell and basal cell carcinoma of the skin, or
• Carcinoma in situ of the cervix, or
• Surgically removed melanoma in situ of the skin (stage 0) with histological confirmed free margins of excision, or
• Prostate cancer (T1a or T1b using the TNM \[tumor, nodes, metastasis\] clinical staging system) that has/have been surgically cured, or
• Any other malignancy that has/have been curatively treated with surgery and/or localized radiation

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

RECRUITING

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Sezary Syndrome; Mycosis Fungoides

Interventions

Photopheresis; mogamulizumab; Immunoglobulin G; Disulfides

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

PUVA Therapy; Ultraviolet Therapy; Phototherapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals

Study Officials

• Christiane R Querfeld

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: October 19, 2022
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (3)