Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides
M.D. Anderson Cancer Center
Summary
To learn if a form of radiation therapy (called ultra-low-dose - total skin electron beam therapy \[ULD-TSEBT\]) in combination with brentuximab vedotin can help to control mycosis fungoides
Description
OBJECTIVES: Primary Objective: The primary objective is to determine the overall response rate (ORR), to ultra-low-dose-total-skin electron beam therapy with brentuximab vedotin (ULD-TSEBT+BV) among patients with stage I-IV mycosis fungoides/Sezary syndrome. Secondary Objective: Key secondary objective is to determine the time to treatment failure (TTF) Determine the safety of brentuximab vedotin (BV) with fractionated ultra-low-dose-total-skin electron beam therapy (ULD-TSEBT) Describe the rate and grade of neuropathy associated with lower-dose BV by using CTCAE V5.0 Assess quality of lif…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Biopsy-confirmed mycosis fungoides in stage I-IV (APPENDICES 3 AND 4); the presence of Sezary cells in the blood is acceptable at original diagnosis or at enrollment into the protocol, as long as the patient has current mycosis fungoides in the skin and the sesary cells in peripheral blood are \< 1000 cells/ microlitre at the time of enrollment. 2. Participants with relapsed/ refractory mycosis fungoides expressing at least 1% CD30 are eligible. 3. Previous systemic anticancer therapy must have been discontinued at least 1 week before treatment 4. In the case of myelosu…
Interventions
- DrugBrentuximab vedotin
Given by Vein (IV)
Location
- MD Anderson Cancer CenterHouston, Texas