RecruitingPhase 2NCT04128072

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


Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrollment

43 participants

Start Date

Mar 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two treatments — a drug called mogamulizumab (which targets cancer cells) and total skin electron beam therapy (a type of radiation that treats the entire skin surface) — for a rare skin cancer called cutaneous T-cell lymphoma (mycosis fungoides). **You may be eligible if...** - You are 18 or older - You have been diagnosed with mycosis fungoides at stage IB, IIA, or IIB - You have already tried at least one other systemic (whole-body) treatment without success - Your blood counts and organ function are within acceptable levels - You have not had total skin electron beam therapy before - Women of childbearing potential agree to use effective contraception during and for 6 months after treatment **You may NOT be eligible if...** - You have previously received mogamulizumab or any anti-CCR4 therapy - You have had total skin electron beam therapy before - Your cancer has spread beyond the skin to distant areas (stage IIIA or higher at any time) - You have active hepatitis B, hepatitis C, or HIV - You have significant heart disease or uncontrolled infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMogamulizumab

• 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).

RADIATIONTotal Skin Electron Beam Therapy (TSEB)

* 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.

DRUGMogamulizumab (subsequent cycles post TSEB)

• 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.


Locations(13)

University Hospitals Copenhagen - Rigshospitalet

Copenhagen, Denmark

CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre

Bordeaux, France

Assistance Publique Hopitaux Paris- APHP Nord - Univ De Paris Cite - Hop. Saint Louis

Paris, France

UniversitaetsMedizin Mannheim

Mannheim, Germany

Muehlenkreiskliniken Johannes Wesling Klinikum Minden

Minden, Germany

Athens University - Attikon University General Hospital

Athens, Greece

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Brescia, Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro

Torino, Italy

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain

Hospital Universitario 12 De Octubre

Madrid, Spain

Hospital Universitario Puerta De Hierro

Madrid, Spain

University Hospitals Birmingham NHS Foundation Trust (UHB) -Queen Elizabeth Medical Centre

Birmingham, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

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NCT04128072