Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients (NCT03587844)
Optimizing Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome, and Lymphomatoid Papulosis
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to test any good and bad effects of the study drug called brentuximab vedotin at a lower dose than is FDA-approved.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (18 items) and avoid the listed exclusions (12 items).
Location: Stanford University Medical Center — Stanford, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Concurrent use of other systemic anti-cancer agents or treatments for mycosis fungoides/sezary syndrome, or lymphomatoid papulosis.
- Grade 2 or greater neuropathy
- Severe renal impairment (CrCL \<30 mL/min)
- Moderate or severe hepatic impairment (Child-Pugh B or Child-Pugh C) ° See Appendix E for Child Pugh Classification chart
- Women of reproductive potential† must have a negative Serum ß human chorionic gonadotropin (ß-HCG) pregnancy test within 1 week of C1D1. They should discuss contraception with treating provider.
- Previous use of brentuximab vedotin (for Cohort 1 ONLY)
- Receiving systemic therapy for another primary malignancy (other than T-cell lymphoma).
- Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator.
- Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy (other than T-cell lymphoma) is permissible after discussion with the MSK Principal Investigator.
- For Cohort 2, patients who previously progressed on the standard 1.8mg/kg dose and schedule of brentuximab vedotin are ineligible.
- A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (8 Sites)
- Stanford University Medical Center — Stanford, California
- Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth — Middletown, New Jersey
- Memorial Sloan Kettering Bergen — Montvale, New Jersey
- Memorial Sloan Kettering Commack — Commack, New York
- Memorial Sloan Kettering Westchester — East White Plains, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Memorial Sloan Kettering Nassau — Uniondale, New York
📞 Contact the Study Coordinator
Phone: (646) 608-3726
Email: moskowia@mskcc.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Mycosis Fungoides
- ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome — Duarte, California
- Pembrolizumab in Combination With Gemcitabine in People With Advanced Mycosis Fungoides or Sézary Syndrome — Basking Ridge, New Jersey
- Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides — Chicago, Illinois
- A Study of VG712 in Patients With Mycosis Fungoides — Tampa, Florida
- Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides — Houston, Texas
Explore by condition: All Mycosis Fungoides clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.