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Combining Mogamulizumab with Total Skin Electron Beam Therapy for Skin Lymphoma

MOGAT: Open-Label, Phase II, Multi-Centre, Study of Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma

Phase 2 Interventional European Organisation for Research and Treatment of Cancer - EORTC · NCT04128072

This study is testing if combining a new drug called Mogamulizumab with a special type of radiation therapy can help people with advanced skin lymphoma who haven't had success with other treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment43 (estimated)
Ages18 Years and up
SexAll
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC Research network
Drugs / interventionsalemtuzumab, mogamulizumab, radiation, methotrexate, prednisone
Locations13 sites (Copenhagen and 12 other locations)
Trial IDNCT04128072 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Mogamulizumab, an anti-CCR4 monoclonal antibody, in combination with Total Skin Electron Beam Therapy (TSEB) for patients diagnosed with Stage IB-IIB Cutaneous T-Cell Lymphoma (CTCL). The study aims to improve treatment outcomes for patients who have not responded to previous systemic therapies. By targeting the skin disease directly and utilizing a systemic approach, the trial seeks to enhance remission rates and quality of life for participants. The trial is designed for patients with advanced stages of CTCL, where standard treatment options are limited.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with Stage IB-IIB Mycosis Fungoides who have failed at least one prior systemic therapy.

Not a fit: Patients with CTCL that has progressed to Stage IIIA or higher will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new effective option for patients with advanced Cutaneous T-Cell Lymphoma.

How similar studies have performed: While there is ongoing research in this area, the combination of Mogamulizumab with TSEB represents a novel approach that has not been extensively tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosis of MF stage IB, IIA or IIB at registration, and MF stage should have never met criteria for stage IIIA or higher.
* Subjects who have failed (refractory or relapsed) at least one prior course of systemic therapy.
* All clinically significant toxic effects of prior cancer therapy to grade ≤ 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE, v.5.0), excluding the specifications required in the criteria 'Adequate haematological and organ function' below
* Males and female subjects ≥ 18 years
* WHO performance status 0-1
* Adequate haematological and organ function:
* absolute neutrophil count (ANC) ≥ 1.0 × 109/L
* platelets ≥ 75 × 109/L (≥ 75,000/mm3)
* bilirubin ≤ 1.5 × upper limit of normal (ULN) except for subjects with Gilbert's syndrome;
* aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN
* serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance \> 50 mL/min using the Cockcroft-Gault formula
* Subjects previously treated with anti-CD4 antibody or alemtuzumab are eligible provided a washout period ≥ 3 months and CD4+ cell counts ≥ 200/mm3
* 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
* Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to the first dose of study treatment
* WOCBP must agree to use effective contraception, defined as oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice through abstinence from sexual intercourse during the study and for 6 months after the last dose.
* Male subjects and their female partners of child bearing potential must be willing to use an appropriate method of contraception defined as oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice through abstinence from sexual intercourse (periodic abstinence, e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception) during the study and for 6 months after the last dose.
* Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment
* Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations

Exclusion Criteria:

* Prior treatment with mogamulizumab, or any other anti-CCR4
* Prior TSEB
* Patients who received localised radiotherapy within 2 weeks prior to registration
* Patients who received any systemic therapy for MF within 4 weeks prior to registration.

Note: In case of rapid progression, if patient has recovered from all toxicities AND last dose occurred more than 5 half lives of the drug/treatment used, patient could be allowed to start earlier after consultation with medical monitor

* History of other malignancy in the past 5 years with the exception of treated carcinoma in situ of the cervix, localized prostate cancer with PSA \<0.1, in-situ melanoma, and non-melanoma skin cancer
* History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
* Known hypersensitivity to CHO cell products or any component of the mogamulizumab formulation (see section 6.1.1)
* Significant uncontrolled intercurrent illness including, but not limited to:
* uncontrolled infection requiring antibiotics;
* clinically significant cardiac disease (class III or IV of the New York Heart Association \[NYHA\] classification);
* unstable angina pectoris;
* angioplasty, stenting, or myocardial infarction within 6 months;
* clinically significant cardiac arrhythmia
* Have active sign of herpes zoster
* Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study.
* Patients with eczema, psoriasis, lichen simplex chronicus, with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
* Rash must cover \<10% of body surface area
* Disease is well controlled at baseline and requires stable use of low to mild potency topical corticosteroids for at least 4 weeks.
* No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 4 months.
* Immunomodulatory drugs or high-dose systemic steroids for concomitant or intercurrent conditions other than T-cell lymphoma within 7 days of registration.

However, stable dose of a low dose systemic systemic corticosteroid (≤10 mg prednisone equivalent per day) or stable dose of a low potency topical corticosteroid for at least 4 weeks prior to the registration is permitted. Subjects may receive intra-articular, intraocular, inhalation or nasal corticosteroids. Initiation of treatment with corticosteroids or increase in dose while on study is not permitted except for the treatment of adverse events.

* Patients who are planned to receive stem cell transplantation
* Has a known history of Human T-lymphotropic virus 1 (HTLV-1), or human immunodeficiency virus (HIV) (test to be performed within 21 days of registration if allowed by local legislation)
* Has known active Hepatitis B or Hepatitis C
* Note: patient will be eligible if:
* Negative hepatitis B surface antigen (HBsAg) test at screening
* Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening . The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Where this trial is running

Copenhagen and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Stage IB-IIB Cutaneous T-Cell LymphomaCutaneous T-Cell LymphomaMogamulizumabTotal Skin Electron Beam therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.