NCT05357794

Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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 life by using the validated Skindex-29 instrument and FACT instrument Determine the complete response rate (CRR) Determine progression-free survival (PFS) Determine overall survival (OS) Note: The study follow up timeframe for CRR, PFS and OS is expected to be two and half years. Assess the relationship between ORR and CD30 expression level Exploratory Objectives: Objective: To identify tumor and peripheral blood markers that predict response to concurrent BV with fractionated ULD-TSEBT, including SS component in the history. Objective: Identification of tumor and peripheral blood markers that are predictive of response to the combination therapy. Define changes in the TCR clonotypes, phenotypes, and inflammatory cytokine levels in biopsy specimens, peripheral blood leukocytes, and serum. Correlate changes in anti-tumor immune responses with clinic-pathological variables and patient outcomes.

Conditions

• Mycosis Fungoides

Interventions

Type	Name	Description
DRUG	Brentuximab vedotin	Given by Vein (IV)

Timeline

• Start date: 2022-10-13
• Primary completion: 2027-01-30
• Completion: 2027-01-30
• First posted: 2022-05-03
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study