Sezary SyndromePhase 2NCT04256018
Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome
A Phase 2 study testing Mogamulizumab and LD TSEBT in people with Sezary Syndrome and Mycosis Fungoides, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sezary Syndrome, Mycosis Fungoides
- What is being tested?
- Mogamulizumab and LD TSEBT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2020to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Adequate hematologic function
- Absolute neutrophil count (ANC) ≥ 1,000 cells/μL (≥ 1,000/mm3)
- Platelets ≥ 75,000 cells/μL (≥ 75,000/mm3).
- 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.
- Adequate renal function
- Calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula.
- If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of graft-vs-host disease (GvHD) and receiving immunosuppressive therapy.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test.
- WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.
- 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.
Who cannot join
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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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Cancer Center
Stanford, California, 94304
Zainab Ahmed, 650-387-4436, zahmed01@stanford.edu
Youn H Kim, MD
About this study
Official title: A Phase 2 Single Center, Single Arm, Open Label Mogamulizumab Combined Upfront With Low Dose Total Skin Electron Beam Therapy (LD TSEBT) in Patients With Mycosis Fungoides (MF) and Sézary Syndrome (SS)
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.
Read the detailed description
Primary Objective:To determine the efficacy of the combination of LD TSEBT and mogamulizumab in patients with MF and SS
Secondary Objective: 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
- Being tested
- Mogamulizumab, LD TSEBT
- Keywords
- CTCL
- Medical subject headings
- Sezary Syndrome, Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MogamulizumabDrug
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 TSEBTRadiation
Also called Low-Dose (LD) Total skin electron beam therapy (TSEBT)
Patients will receive total skin dose of 12 Gy fractionated at 4 to 6 Gy per week, for 2-3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Mogamulizumab; Radiation: LD TSEBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
Time-to-Next Significant Treatment (TTNT)
Time-to-next significant treatment (TTNT) will be assessed as the amount of time from starting study treatment through the initiation of any non study systemic therapy. The outcome will be reported as the median TTNT.
Measured: 3 years
Progression free survival (PFS)
Progression free survival (PFS) will be assessed as the amount of time from starting study treatment to progression of disease (PD) or death due to any cause.
Measured: 3 years
Duration of response (DOR)
Duration of response (DOR) will be assessed in those participants who achieve either a complete response (CR) or partial response (PR), and with duration as time to progressive disease or the initiation of a non-study systemic therapy.
- 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.
Measured: 3 years
Patient reported Quality of Life (QoL)
The Skindex 29 survey was used to evaluate the effect of skin conditions on participant's quality of life (QoL). Surveys were administered at the beginning of every treatment cycle and continuing through up to 3 years of treatment. The survey is a 30 item questionnaire with possible answers scored as 1 to 5, with a score of 1 indicating no negative effect, and a score of 5 indicating a constant ("all the time") negative effect. Response ranges are from 30 to 150. The outcome will be reported as the median QoL score with standard deviation.
Measured: 3 years
Treatment-related Adverse Events ≥ Grade 3
Toxicity will be assessed as adverse events that are severe or greater (≥ Grade 3), and possibly, probably, or definitely related to mogamulizumab or low dose total skin electron beam therapy (LD TSEBT), and occurring within 12 months of starting treatment. The outcome will be reported as the total number of qualifying events, a number without dispersion.
Measured: 12 months
Proportion of Participants With ≥4, ≥6, and ≥12 Months of Response Duration (ORR4, ORR6, and ORR12)
ORR4, ORR6, and ORR12 will be assessed as the proportions of patients who have at least 4, 6, or 12 months of response duration, respectively, among those who achieve either a complete response (CR) or partial response (PR). The outcomes will be reported as numbers without dispersion.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start30 Mar 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sezary SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youn H Kim, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256018
- Sponsor's protocol ID
- IRB-53490
- Other IDs
- LYMNHL0155, NCI-2020-05893
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2020
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Single Center, Single Arm, Open Label Mogamulizumab Combined Upfront With Low Dose Total Skin Electron Beam Therapy (LD TSEBT) in Patients With Mycosis Fungoides (MF) and Sézary Syndrome (SS)
- ClinicalTrials.gov ID
- NCT04256018
- Acronym / sponsor ID
- IRB-53490
- Conditions
- Sezary Syndrome, Mycosis Fungoides
- Keywords
- CTCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective:To determine the efficacy of the combination of LD TSEBT and mogamulizumab in patients with MF and SS
Secondary Objective: 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LD TSEBT | Experimental | Drug: Mogamulizumab, Radiation: LD TSEBTMogamulizumab 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Stages IB-IV MF or SS
Key exclusion criteria (7 listed)
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Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MogamulizumabAdministered 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. | Drug | LD TSEBT |
| LD TSEBTAlso: Low-Dose (LD) Total skin electron beam therapy (TSEBT)Patients will receive total skin dose of 12 Gy fractionated at 4 to 6 Gy per week, for 2-3 weeks | Radiation | LD TSEBT |
Primary outcome
Overall response rate (ORR)
Time frame: 12 months
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.
6 secondary outcomes
Time-to-Next Significant Treatment (TTNT)
Time frame: 3 years
Progression free survival (PFS)
Time frame: 3 years
Duration of response (DOR)
Time frame: 3 years
Patient reported Quality of Life (QoL)
Time frame: 3 years
Treatment-related Adverse Events ≥ Grade 3
Time frame: 12 months
Proportion of Participants With ≥4, ≥6, and ≥12 Months of Response Duration (ORR4, ORR6, and ORR12)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Youn H Kim, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mogamulizumab and LD TSEBT in people with Sezary Syndrome and Mycosis Fungoides, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zainab Ahmed (650-387-4436, zahmed01@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.