TrialCompass TCL
Find TrialsAI AssistantLetter GeneratorAbout
Back to results
Phase 2RecruitingPriority 3 · Moderate priorityNCT04128072

Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma

ClinicalTrials.gov

Plain-language summary

This Phase 2 trial is testing Mogamulizumab, Total Skin Electron Beam Therapy (TSEB), and other medications for people whose cutaneous T-cell lymphoma (skin lymphoma) has come back or has not responded to previous treatment. The study measures how well this treatment works and monitors for side effects. This trial does not currently list US sites.

Who can join (key eligibility)

  • Age 18 Years or older
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

Mogamulizumab (DRUG): • Patients will receive mogamulizumab 1.0 mg/kg IV over at least 1 hour on Days 1, 8, 15 and 22 of the first 28 day treatment cycle (C1) and on Days 1 and 15 of subsequent 28 day cycle (C2). | Total Skin Electron Beam Therapy (TSEB) (RADIATION): * After completion of C2, patients will be administered TSEB at a dose of 12 Gy in 8 fractions (4 fractions per week). TSEB will start 28 days (window of + 7 days) after mogamulizumab (C2 D1). * In case of toxicity from mogamulizumab, the maximum delay permitted for the start of TSEB is 2 weeks. * If recovery to at least grade 1 from toxicity exceeds the 2 weeks interval, please contact the medical monitor. * Mogamulizumab is stopped during TSEB administration. | Mogamulizumab (subsequent cycles post TSEB) (DRUG): • Mogamulizumab will be restarted at a dose of 1.0 mg/kg IV on Days 1, 8, 15 and 22 for cycle 3. Subsequent cycles will be administered as for C2. Treatment with mogamulizumab will be continued until disease progression (PD) or the occurrence of another withdrawal criterion.

Drugs / treatments
Mogamulizumab, Total Skin Electron Beam Therapy (TSEB), Mogamulizumab (subsequent cycles post TSEB)
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Phase 2
Status
Recruiting
Design
Non-randomized, open-label
Enrollment target
43 patients
Primary endpoint
Progression Free Survival Rate at 48 weeks
Ages
18 Years to —
Start date
2023-03-07
Est. completion
2027-01

Locations

0 US sites · 13 total

No US sites currently listed.

Contact

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC (NETWORK)
Contact
EORTC EORTC HQ | eortc@eortc.org | +32 2 774 1611

Tags

CTCLMaintenanceRelapsed/Refractory
TrialCompass — Clinical Trial Summary

Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma

NCT04128072

Phase: Phase 2 | Status: Recruiting | Priority: Medium

Plain-language summary

This Phase 2 trial is testing Mogamulizumab, Total Skin Electron Beam Therapy (TSEB), and other medications for people whose cutaneous T-cell lymphoma (skin lymphoma) has come back or has not responded to previous treatment. The study measures how well this treatment works and monitors for side effects. This trial does not currently list US sites.

Who can join

  • Age 18 Years or older
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)

What's being tested

Mogamulizumab (DRUG): • Patients will receive mogamulizumab 1.0 mg/kg IV over at least 1 hour on Days 1, 8, 15 and 22 of the first 28 day treatment cycle (C1) and on Days 1 and 15 of subsequent 28 day cycle (C2). | Total Skin Electron Beam Therapy (TSEB) (RADIATION): * After completion of C2, patients will be administered TSEB at a dose of 12 Gy in 8 fractions (4 fractions per week). TSEB will start 28 days (window of + 7 days) after mogamulizumab (C2 D1). * In case of toxicity from mogamulizumab, the maximum delay permitted for the start of TSEB is 2 weeks. * If recovery to at least grade 1 from toxicity exceeds the 2 weeks interval, please contact the medical monitor. * Mogamulizumab is stopped during TSEB administration. | Mogamulizumab (subsequent cycles post TSEB) (DRUG): • Mogamulizumab will be restarted at a dose of 1.0 mg/kg IV on Days 1, 8, 15 and 22 for cycle 3. Subsequent cycles will be administered as for C2. Treatment with mogamulizumab will be continued until disease progression (PD) or the occurrence of another withdrawal criterion.

Drugs / treatments: Mogamulizumab, Total Skin Electron Beam Therapy (TSEB), Mogamulizumab (subsequent cycles post TSEB)

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 43 patients

Primary endpoint: Progression Free Survival Rate at 48 weeks

Ages: 18 Years to —

Start date: 2023-03-07 | Est. completion: 2027-01

Locations

0 US sites · 13 total

Contact

EORTC EORTC HQ | eortc@eortc.org | +32 2 774 1611

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC (NETWORK)

Tags

CTCL · Maintenance · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT04128072

Prepared using TrialCompass (trialcompass.com) on June 19, 2026. For informational purposes only. Always discuss with your healthcare team.
TrialCompass

A free tool to help patients, caregivers, and clinicians find and understand clinical trials for T-cell lymphoma.

Explore

  • Find Trials
  • AI Assistant
  • Letter Generator
  • About
  • Share Your Feedback
  • Terms of Use
  • Privacy Policy

Data sourced from ClinicalTrials.gov.

For informational purposes only. Not medical advice — always consult your healthcare team.

Built with care for the rare cancer community.

Data last updated: June 2026

Edit with