NCT04256018 Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome
| NCT ID | NCT04256018 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stanford University |
| Condition | Sezary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2020-03-30 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2020-03-30 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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: <!-- --> 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.
Contact & Investigator
Youn H Kim, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT04256018 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sezary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04256018 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04256018 currently recruiting?
Yes, NCT04256018 is actively recruiting participants. Contact the research team at zahmed01@stanford.edu for enrollment information.
Where is the NCT04256018 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT04256018 clinical trial?
NCT04256018 is sponsored by Stanford University. The principal investigator is Youn H Kim, MD at Stanford University. The trial plans to enroll 30 participants.