Actively Recruiting
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-03
58
Participants Needed
8
Research Sites
469 weeks
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
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.
CONDITIONS
Official Title
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed mycosis fungoides or Sezary syndrome with stage IB or higher
- CD30 negative mycosis fungoides patients are eligible
- Age 18 years or older
- ECOG Performance Score of 2 or less
- For Cohort 1, patients must not have received brentuximab vedotin before
- For Cohort 2, patients who previously had brentuximab vedotin for MF/SS are eligible, except those discontinued due to toxicity
- Previous systemic anti-cancer therapy stopped at least 2 weeks before treatment
- Use of topical or systemic steroids equivalent to 10 mg/day prednisone or less may be allowed if dose is stable
- If HIV positive, must be on stable anti-retroviral treatment for 12 weeks before treatment with CD4 count above 200
- Females of childbearing potential must use acceptable birth control
- For lymphomatoid papulosis, pathologically confirmed diagnosis
- Requires systemic treatment as decided by doctor
- Age 18 years or older
- ECOG Performance Score of 2 or less
- Previous systemic anti-cancer therapy stopped at least 2 weeks before treatment
- Use of topical or systemic steroids equivalent to 10 mg/day prednisone or less may be allowed if dose is stable
- If HIV positive, must be on stable anti-retroviral treatment for 12 weeks before treatment with CD4 count above 200
- Females of childbearing potential must use acceptable birth control
You will not qualify if you...
- Use of other systemic anti-cancer agents or treatments concurrently
- Grade 2 or greater neuropathy
- Severe kidney problems (creatinine clearance less than 30 mL/min)
- Moderate or severe liver problems (Child-Pugh B or C)
- Women of reproductive potential must have a negative pregnancy test within 1 week before treatment and discuss contraception
- Previous use of brentuximab vedotin for Cohort 1 patients
- Receiving systemic therapy for another primary cancer (other than T-cell lymphoma) unless approved
- For Cohort 2, patients who progressed on standard 1.8 mg/kg dose of brentuximab vedotin are not eligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
P
Patricia Myskowski, MD
CONTACT
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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