Recruiting
Phase 2

Mogamulizumab & Low-Dose Tx

Sponsor:

Stanford University

Code:

NCT04256018

Conditions

Sezary Syndrome

Mycosis Fungoides

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mogamulizumab

LD TSEBT

Study Details

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

Study ID

NCT04256018

Start date

Mar 30, 2020

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Stages IB-IV MF or SS

1. Stages IB-IV MF or SS
2. At least 1 prior standard-of-care therapy
3. 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
4. ≥ 18 years of age
5. ECOG performance status of 0 to 2
6. 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).
7. MF and a known history of non-complicated staphylococcus colonization/infection is eligible provided that stable doses of prophylactic antibiotics continue.
8. 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.
9. Adequate hematologic function

• Absolute neutrophil count (ANC) ≥ 1,000 cells/μL (≥ 1,000/mm3)

• Platelets ≥ 75,000 cells/μL (≥ 75,000/mm3).
10. Adequate hepatic function

  • Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN). Exception: If Gilbert's syndrome; then ≤ 5 times ULN.
  • Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN; or ≤ 5.0 x ULN in the presence of known hepatic involvement by CTCL.
11. Adequate renal function

• Calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula.
12. If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of graft-vs-host disease (GvHD) and receiving immunosuppressive therapy.
13. Women of childbearing potential (WOCBP) must have a negative pregnancy test.
14. WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.
15. Male participants and their female partners of child bearing potential must be willing to use an appropriate method of contraception during the study and for 3 months after the last dose.

Exclusion Criteria:

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1. MF with limited disease (Stage IA) or central nervous system (CNS) disease
2. 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)
3. Pregnant or breastfeeding
4. Active autoimmune disease or history deemed by the investigator to be clinically significant
5. Known human immunodeficiency virus (HIV) positivity; or active hepatitis B or C.
6. 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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LD TSEBT

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)

Interventions

Mogamulizumab

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

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

Primary outcome measure

  • Overall response rate (ORR) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Stanford Cancer Center

Recruiting

Stanford, California, United States, 94304

Contacts

Principal Investigator:

Youn H Kim, MD

More Information

Sponsor

Stanford University

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • CTCL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stanford University on 2026-07-01.