NCT03587844 · Memorial Sloan Kettering Cancer Center
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
brentuximab vedotin
MF/SS Brentuximab vedotin 0.9 mg/kg 0R 1.2 mg/kg.
DRUG
brentuximab vedotin
LyP Brentuximab vedotin 0.9 mg/kg2
DRUG
brentuximab vedotin
MF/SS prior brentuximab vedotin-Brentuximab vedotin dose to be determined from Cohort 1
Primary outcome measures
overall response
Time frame: 1 year
measure best overall response during treatment by the global response score, which incorporates the mSWAT, as well as CT scan for patients with baseline nodal/visceral involvement and flow cytometry for patients with baseline positive peripheral flow cytometry
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Mycosis fungoides (MF) and Sezary Syndrome (SS) 1. Pathologically confirmed mycosis fungoides/sezary syndrome at the enrolling institution, disease stage IB (defined as patches, plaque, or papules that involve 10% of the skin surface viscera) or higher ° CD30 negative mycosis fungoides patients are eligible. 2. Age ≥ 18 years 3. ECOG Performance Score ≤ 2 4. For Cohort 1, patients who have not received brentuximab vedotin are eligible. 5. For Cohort 2, patients who have previously had brentuximab vedotin for MF/SS are eligible. Patients previously treated on Cohort 1 who were discontinued due to toxicity are not eligible for Cohort 2. 6. Previous systemic anti-cancer therapy must have been discontinued at least 2 weeks prior to treatment. ° See section 6.2 Subject
Exclusion criteria
- for guidelines regarding adjuvant and maintenance therapy for prior malignancy. 7. Topical or systemic steroids (equivalent to ≤ 10 mg/day of prednisone) may be considered if d
Where
- Stanford, California
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- East White Plains, New York
- New York, New York
- Uniondale, New York
Collaborators
Seagen Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 3, 2026 · Source of record for eligibility and locations