OncoMatch/Clinical Trials/NCT04128072
Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma
Is NCT04128072 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Mogamulizumab and Mogamulizumab (subsequent cycles post TSEB) for stage ib-iib cutaneous t-cell lymphoma.
Treatment: Mogamulizumab · Mogamulizumab (subsequent cycles post TSEB) — Cutaneous T-Cell Lymphoma (CTCL) has a chronic, relapsing course with patients undergoing multiple, consecutive therapies. Treatment aims at the clearance of skin disease, minimization of recurrence, prevention of disease progression and preservation of quality of life. The treatment of CTCL is primarily determined by the disease extent. Prolonged complete remissions have been obtained with skin-directed therapies in early stage Mycosis fungoides (MF) (IA-IIA), whereas advanced stages CTCL (IIB-IVB) are often refractory to treatment and, thus, have an unfavorable prognosis. Currently, there is no standard treatment option for CTCL, especially for advanced stages, and the optimal treatment sequence is still debated with a large variability in the therapeutic approach across countries. Patients with advanced-stage disease or refractory cutaneous CTCL should be treated with systemic therapies and, whenever possible, should be offered to participate in clinical trials. Currently, there is a urgent call for new treatments in CTCL with higher response rate and prolonged time to progression; In this study, we propose a very innovative treatment schedule in which mogamulizumab is used before Total Skin Electron Beam therapy (TSEB) for systemic disease control and as a maintenance treatment after skin-directed therapy. We hypothesize that our regimen will show a more manageable toxicity profile than a combination treatment and allow for a long-term mogamulizumab administration.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Disease stage
Required: Stage IB, IIA, IIB
Excluded: Stage IIIA, IIIB, IIIC, IV
Diagnosis of MF stage IB, IIA or IIB at registration, and MF stage should have never met criteria for stage IIIA or higher.
Performance status
WHO 0–1
Prior therapy
Must have received: systemic therapy
Subjects who have failed (refractory or relapsed) at least one prior course of systemic therapy.
Cannot have received: anti-CCR4 antibody (mogamulizumab)
Prior treatment with mogamulizumab, or any other anti-CCR4
Cannot have received: total skin electron beam therapy
Prior TSEB
Cannot have received: localized radiotherapy
Patients who received localised radiotherapy within 2 weeks prior to registration
Cannot have received: systemic therapy
Patients who received any systemic therapy for MF within 4 weeks prior to registration.
Lab requirements
Blood counts
ANC ≥ 1.0 × 10^9/L; platelets ≥ 75 × 10^9/L (≥ 75,000/mm3)
Kidney function
serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance > 50 mL/min using the Cockcroft-Gault formula
Liver function
bilirubin ≤ 1.5 × ULN except for subjects with Gilbert's syndrome; AST and ALT ≤ 2.5 × ULN
Cardiac function
Clinically normal cardiac function based on 12-lead ECG and above the institutional lower limit of normal for left ventricular ejection fraction assessed either by multi-gated acquisition scan or cardiac ultrasound
Adequate haematological and organ function: ANC ≥ 1.0 × 10^9/L; platelets ≥ 75 × 10^9/L (≥ 75,000/mm3); bilirubin ≤ 1.5 × ULN except for subjects with Gilbert's syndrome; AST and ALT ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance > 50 mL/min using the Cockcroft-Gault formula. Clinically normal cardiac function based on 12-lead ECG and above the institutional lower limit of normal for left ventricular ejection fraction assessed either by multi-gated acquisition scan or cardiac ultrasound
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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