Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome

NCT04256018 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: IRB-53490LYMNHL0155NCI-2020-05893
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy of the combination of LD-TSEBT and mogamulizumab in patients with MF and SS. And to evaluate the secondary measures of clinical benefit of the combination therapy and to evaluate the safety and tolerability of the combination in patients with MF and SS.

Conditions

Sezary Syndrome; Mycosis Fungoides

Keywords

CTCL

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Response to treatment will be assessed as the number and proportion of participants who achieve either a complete response (CR) or partial response (PR). The outcome is reported as numbers without dispersion. Clinical response will be assessed as follows. * CR: Complete disappearance of all clinical evidence of disease * PR: Decrease in size or amount of measurable disease lesions * Progressive disease (PD): Worsening of lesions; appearance of new lesions; or recurrence of lesions * Stable disease (SD): Disease status that is neither CR, PR, nor PD.

  12 months

Secondary Outcomes (6)

• Time-to-Next Significant Treatment (TTNT)

  3 years

• Progression free survival (PFS)

  3 years

• Duration of response (DOR)

  3 years

• Patient reported Quality of Life (QoL)

  3 years

• Treatment-related Adverse Events ≥ Grade 3

  12 months

Study Arms (1)

LD TSEBT

EXPERIMENTAL

Mogamulizumab with low dose total skin electron beam therapy. • LD (12 Gy) TSEBT will be initiated on Cycle 1 Day 2 (± 2 days) of mogamulizumab over 2 to 3 week period per standard of care (SOC), as tolerated. Mogamulizumab (1 mg/kg) will be administered over 60 minutes as follows (per SOC and FDA approved use in MF and SS): * Cycle 1 only: Days1; 8; 15; and 22 (± 2 days) * Cycle 2 and beyond: Day 1 and Day 15 (± 3 days)

Drug: Mogamulizumab; Radiation: LD TSEBT

Interventions

Mogamulizumab DRUG

Administered 1 mg/kg as an intravenous infusion over at least 60 minutes on Days 1, 8, 15, and 22 of the first 28 day cycle and on Days 1 and 15 of each subsequent cycle.

LD TSEBT

LD TSEBT RADIATION

Patients will receive total skin dose of 12 Gy fractionated at 4 to 6 Gy per week, for 2-3 weeks

Also known as: Low-Dose (LD) Total skin electron beam therapy (TSEBT)

LD TSEBT

Eligibility Criteria

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

You may qualify if:

• Stages IB-IV MF or SS
• Stages IB-IV MF or SS
• At least 1 prior standard-of-care therapy
• Prior LD-TSEBT (\> 3 months prior) and prior mogamulizumab is allowed, as long as progressive disease (PD) did not occur while on therapy, and did not discontinue due to toxicities
• ≥ 18 years of age
• ECOG performance status of 0 to 2
• All clinically-significant toxic effects of prior cancer therapy resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE, v 5.0).
• MF and a known history of non-complicated staphylococcus colonization/infection is eligible provided that stable doses of prophylactic antibiotics continue.
• The following minimum wash-out from previous treatments are required (prior to 1st day of treatment), if applicable.
• ≥ 2weeks for retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or other systemic anti-cancer/CTCL therapies
• ≥ 2 weeks for phototherapy, local radiation therapy
• ≥ 2 weeks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod)
• ≥ 12 weeks for total skin electron beam therapy
• \> 12 weeks for alemtuzumab
• Rapidly progressive malignant disease may be enrolled prior to above periods after discussion with the Protocol Director.

You may not qualify if:

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• MF with limited disease (Stage IA) or central nervous system (CNS) disease
• Concomitant corticosteroid use. (with the exception that topical steroid and oral prednisone are allowed at ≤ 20 mg/day, if patient has been on a stable dose for at least 2 weeks prior to 1st day of treatment)
• Pregnant or breastfeeding
• Active autoimmune disease or history deemed by the investigator to be clinically significant
• Known human immunodeficiency virus (HIV) positivity; or active hepatitis B or C.
• Active herpes simplex or herpes zoster. Those receiving prophylaxis for herpes and who started taking medication at least 30 days prior to the Screening Visit, and have no active signs of active infection, and whose last active infection was more than 6 months ago, may enter the study, and should continue to take the prescribed medication for the duration of the study.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Cancer Center

Stanford, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Sezary Syndrome; Mycosis Fungoides

Interventions

mogamulizumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; 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

Study Officials

• Youn H Kim, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zainab Ahmed

CONTACT

650-387-4436; zahmed01@stanford.edu

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: February 3, 2020
• First Posted: February 5, 2020
• Study Start: March 30, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)