Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma
Plain-language summary
This trial is testing Mogamulizumab for patients with cutaneous T-cell lymphoma (CTCL), including mycosis fungoides or Sézary syndrome whose disease has come back or stopped responding to prior treatment as well as those who have responded to prior therapy and may receive maintenance treatment. This is a Phase 2 trial, which means researchers are studying how well the treatment works and monitoring for side effects. Researchers want to learn whether this approach can help control the lymphoma. This trial does not currently have sites in the United States. The trial is currently recruiting patients.
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.
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