Actively Recruiting
Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides
Led by M.D. Anderson Cancer Center · Updated on 2026-01-12
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a combination of ultra-low-dose total skin electron beam therapy (ULD-TSEBT) and the drug brentuximab vedotin can help control mycosis fungoides, a type of skin lymphoma that can range from early to advanced stages. This phase 2 study aims to determine how well this combined treatment works, its safety, and the impact on patients' quality of life. Additional goals include understanding how tumor markers relate to treatment response and examining immune system changes during therapy. Participants will receive radiation therapy to their entire skin surface over two days per treatment cycle, with each session lasting about 60 to 90 minutes. Alongside radiation, participants will receive brentuximab vedotin administered intravenously every three months over a 12-month period. The study follows patients for about two and a half years to assess long-term outcomes such as complete response rate, progression-free survival, and overall survival. During the study, participants will undergo various assessments including biopsies, blood tests, and quality of life questionnaires. Researchers will monitor treatment response using the overall response rate and track side effects like neuropathy using standardized criteria. Participants' immune responses and tumor markers will also be evaluated to understand how these relate to treatment success. The total time participants spend in the study includes treatment and follow-up visits extending over multiple years.
CONDITIONS
Brief Title
Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-confirmed mycosis fungoides in stage I-IV
- Presence of Sezary cells in blood acceptable if under 1000 cells/microlitre at enrollment
- Relapsed or refractory mycosis fungoides with at least 1% CD30 expression
- Previous systemic anticancer therapy stopped at least 1 week before treatment
- Myelosuppressive chemotherapy allowed if blood counts have recovered (WBC > 1000, platelets > 50K)
- Stable dose of topical or systemic steroids equivalent to 10 mg/day prednisone allowed
- Age 18 years or older
- ECOG performance status score of 3 or less
- No required wash-out period for prior therapies
- HIV+ participants must be on stable antiretroviral treatment for 12 weeks with CD4 count > 200
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Concurrent use of other systemic anticancer agents or treatments for mycosis fungoides or Sezary syndrome (except adrenal insufficiency steroids)
- Neuropathy grade 2 or higher
- Severe kidney impairment (creatinine clearance < 30 mL/min)
- Moderate or severe liver impairment (Child-Pugh B or C)
- Women of reproductive potential must have negative pregnancy test and agree to use effective contraception during and after treatment
- Receipt of systemic therapy for another primary malignancy (except T-cell lymphoma) without approval
- Unstable cardiac disease or other serious illness preventing treatment
- Any medical condition or lab result deemed likely to interfere with study participation
- Use of strong CYP3A4 or P-gp inhibitors/inducers should be avoided due to drug interactions
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 - 12 months
Participants receive ultra-low-dose total-skin electron beam therapy over 2 days and brentuximab vedotin given intravenously every 3 months for up to 12 months.
Radiation therapy over 2 days and 4 infusion visits approximately every 3 months
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
Bouthaina Dabaja, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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