Actively Recruiting
Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2024-04-05
43
Participants Needed
13
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Mycosis Fungoides stage IB, IIA or IIB, never meeting criteria for stage IIIA or higher
- Failed at least one prior systemic therapy (refractory or relapsed)
- Clinically significant toxic effects of prior cancer therapy at grade 1 or less per NCI-CTCAE v5.0, excluding specific haematological and organ function criteria
- Male or female aged 18 years or older
- WHO performance status of 0 or 1
- Adequate haematological and organ function including ANC 1.0 10^9/L, platelets 75 10^9/L, bilirubin 1.5 ULN (except Gilbert's syndrome), AST and ALT 2.5 ULN, serum creatinine 1.5 ULN or creatinine clearance > 50 mL/min
- Subjects previously treated with anti-CD4 antibody or alemtuzumab eligible after 3 months washout and CD4+ cell count 200/mm3
- Normal cardiac function based on ECG and left ventricular ejection fraction testing
- Women of childbearing potential must have a negative pregnancy test within 3 days prior to treatment and agree to effective contraception during and 6 months after treatment
- Male subjects and female partners of childbearing potential must agree to effective contraception during and 6 months after treatment
- Female subjects who are breast feeding must stop nursing before treatment and until 6 months after last dose
- Written informed consent according to regulations
You will not qualify if you...
- Prior treatment with mogamulizumab or other anti-CCR4 therapies
- Prior Total Skin Electron Beam Therapy (TSEB)
- Localized radiotherapy within 2 weeks before registration
- Systemic therapy for Mycosis Fungoides within 4 weeks before registration, except in rapid progression cases after consultation
- History of other malignancies in past 5 years except certain treated cancers
- History of severe allergic reactions to chimeric, human, or humanized antibodies or fusion proteins
- Known hypersensitivity to CHO cell products or mogamulizumab components
- Significant uncontrolled illnesses such as severe infections or serious cardiac diseases
- Active herpes zoster infection
- Planned stem cell transplantation
- Known infection with HTLV-1, HIV, active Hepatitis B or C
- Psychological, social, or geographical issues that could interfere with study participation
- Use of immunomodulatory drugs or high-dose steroids within 7 days before registration, except stable low-dose corticosteroids
- Patients with eczema, psoriasis, or lichen simplex chronicus only if rash covers less than 10% body surface area and is well controlled with low to mild topical corticosteroids
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 13 locations
1
University Hospitals Copenhagen - Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
2
CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre
Bordeaux, France, 33075
Actively Recruiting
3
Assistance Publique Hopitaux Paris- APHP Nord - Univ De Paris Cite - Hop. Saint Louis
Paris, France, 75010
Actively Recruiting
4
UniversitaetsMedizin Mannheim
Mannheim, Germany, 68167
Actively Recruiting
5
Muehlenkreiskliniken Johannes Wesling Klinikum Minden
Minden, Germany, 32429
Actively Recruiting
6
Athens University - Attikon University General Hospital
Athens, Greece, 12462
Actively Recruiting
7
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, Italy, 25123
Actively Recruiting
8
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro
Torino, Italy, 10126
Actively Recruiting
9
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
10
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041
Actively Recruiting
11
Hospital Universitario Puerta De Hierro
Madrid, Spain, 28222
Actively Recruiting
12
University Hospitals Birmingham NHS Foundation Trust (UHB) -Queen Elizabeth Medical Centre
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
13
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
E
EORTC EORTC HQ
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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