Actively Recruiting
Optimizing Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome, and Lymphomatoid Papulosis
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-03
58
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
S
Seagen Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of brentuximab vedotin at lower doses than those approved by the FDA in patients with Mycosis Fungoides (MF), Sezary Syndrome (SS), and Lymphomatoid Papulosis (LyP). This phase 2 trial aims to understand both the beneficial and adverse effects of the drug at these reduced doses. The study includes patients with confirmed diagnoses of these conditions and focuses on optimizing dosing to improve treatment outcomes. Participants receive brentuximab vedotin in three different groups based on their treatment history and condition. Patients with MF/SS who have not received brentuximab vedotin are treated with doses of 0.9 mg/kg or 1.2 mg/kg. Those previously treated with the drug receive the dose determined to be promising in the first group, currently 1.2 mg/kg. Patients with LyP receive 0.9 mg/kg of the drug via intravenous infusion every three weeks. Treatment delays longer than eight weeks due to toxicity can result in removal from the study. During the study, participants undergo regular monitoring for treatment response and safety. The primary outcome measure is the overall response after one year. Assessments include clinical evaluations, performance status checks, and safety monitoring for side effects such as neuropathy or organ impairment. The study also requires stable use of steroids if applicable and adherence to birth control for females of childbearing potential. Participation may last several months with ongoing evaluations throughout the treatment period and follow-up as needed.
CONDITIONS
Brief Title
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Pathologically confirmed Mycosis Fungoides or Sezary Syndrome at stage IB or higher
- CD30 negative Mycosis Fungoides patients are eligible
- ECOG Performance Score of 2 or less
- For Cohort 1: No prior brentuximab vedotin treatment
- For Cohort 2: Prior brentuximab vedotin treatment for MF/SS allowed, but not if discontinued due to toxicity
- Previous systemic anti-cancer therapy stopped at least 2 weeks before treatment
- Stable use of topical or systemic steroids (equivalent to 10 mg/day prednisone or less) allowed
- If HIV positive, stable anti-retroviral treatment for at least 12 weeks and CD4 count above 200
- Females of childbearing potential must use acceptable birth control
- For Lymphomatoid Papulosis: Pathologically confirmed diagnosis requiring systemic treatment, age 18 or older, ECOG score 2 or less, similar steroid and HIV criteria as above
You will not qualify if you...
- Concurrent use of other systemic anti-cancer treatments for MF/SS or LyP
- Grade 2 or higher neuropathy
- Severe kidney impairment (Creatinine Clearance less than 30 mL/min)
- Moderate or severe liver impairment (Child-Pugh B or C)
- Women of reproductive potential must have a negative pregnancy test within 1 week before treatment
- Prior brentuximab vedotin use for Cohort 1 patients
- Receiving systemic therapy for another primary cancer (except T-cell lymphoma)
- Patients who progressed on standard 1.8 mg/kg brentuximab vedotin dose for Cohort 2
- Female participants who are not surgically or naturally postmenopausal for 24 months without appropriate contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive brentuximab vedotin intravenously at doses determined by their cohort assignment to treat Mycosis Fungoides, Sezary Syndrome, or lymphomatoid papulosis. Treatment may be held or adjusted based on participant health and toxicity.
Infusions every 3 weeks with visits coinciding with treatment
Trial Site Locations
Total: 8 locations
1
Stanford University Medical Center
Stanford, California, United States, 94305-5408
Actively Recruiting
2
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester
East White Plains, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
A
Alison Moskowitz, MD
P
Patricia Myskowski, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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