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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
• 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).
* 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 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.
University Hospitals Copenhagen - Rigshospitalet
Copenhagen, Denmark
RECRUITINGCHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre
Bordeaux, France
RECRUITINGAssistance Publique Hopitaux Paris- APHP Nord - Univ De Paris Cite - Hop. Saint Louis
Paris, France
RECRUITINGUniversitaetsMedizin Mannheim
Mannheim, Germany
RECRUITINGMuehlenkreiskliniken Johannes Wesling Klinikum Minden
Minden, Germany
RECRUITINGAthens University - Attikon University General Hospital
Athens, Greece
RECRUITINGAzienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, Italy
RECRUITINGAzienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro
Torino, Italy
RECRUITINGHospital De La Santa Creu I Sant Pau
Barcelona, Spain
RECRUITINGHospital Universitario 12 De Octubre
Madrid, Spain
RECRUITING...and 3 more locations
Progression Free Survival Rate at 48 weeks
The primary endpoint is the progression free survival rate, assessed at 48 weeks after start of mogamulizumab
Time frame: Up to 48 weeks after start of mogamulizumab for each patient
Occurrence of Adverse Events
Time frame: 48 months after last patient in
Response rate to both mogamulizumab and TSEB
Proportion of patients achieving partial response or complete response according to EORTC-ISCL-USCLC criteria
Time frame: From the first patient treatment start till 48 weeks as of last patient in
Progression-free survival
From start of mogamulizumab to the first date of progressive disease or death from any cause
Time frame: From the first patient treatment start till 48 weeks as of last patient in
Overall survival
Start of mogamulizumab till the date of death from any cause
Time frame: From the first patient treatment start till 5 years after last patient treatment
Time to progression
From start of mogamulizumab to the date of first documentation of progressive disease or death due to progressive disease, whichever occurs first
Time frame: From the first patient treatment start till 48 weeks as of last patient in
Duration of response
Duration of response will be measured for patients achieving a partial response or complete response are first met until the first date that recurrent or progressive disease
Time frame: From the first patient treatment start till 48 weeks as of last patient in
Time to next treatment
From time from initiation of mogamulizumab until the time the initiation of any total skin-equivalent treatment (topical treatment to \>50% of body surface, phototherapy, second TSEB) or systemic treatment is recorded
Time frame: From the first patient treatment start till 48 weeks as of last patient in
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