NCT04128072View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

March 7, 2023

Primary Completion Date

October 31, 2026

Study Completion Date

January 31, 2027

Conditions
Stage IB-IIB Cutaneous T-Cell Lymphoma
Interventions
DRUG

Mogamulizumab

• 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).

RADIATION

Total 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."

DRUG

Mogamulizumab (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."

Trial Locations (13)

2100

RECRUITING

University Hospitals Copenhagen - Rigshospitalet, Copenhagen

10126

RECRUITING

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

12462

RECRUITING

Athens University - Attikon University General Hospital, Athens

25123

RECRUITING

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, Brescia

28041

RECRUITING

Hospital Universitario 12 De Octubre, Madrid

28222

RECRUITING

Hospital Universitario Puerta De Hierro, Madrid

32429

RECRUITING

Muehlenkreiskliniken Johannes Wesling Klinikum Minden, Minden

33075

RECRUITING

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

68167

RECRUITING

UniversitaetsMedizin Mannheim, Mannheim

75010

RECRUITING

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

08041

RECRUITING

Hospital De La Santa Creu I Sant Pau, Barcelona

B15 2TH

RECRUITING

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

M20 4BX

RECRUITING

The Christie NHS Foundation Trust, Manchester

All Listed Sponsors
lead

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK