Clinical trial • Phase II • Oncology|Rare Disease
MOGAMULIZUMAB for Cutaneous T-cell lymphoma | Mycosis fungoides | Sézary syndrome
Phase II trial of MOGAMULIZUMAB for Cutaneous T-cell lymphoma | Mycosis fungoides | Sézary syndrome. open-label, none/not specified-controlled.
Overview
- Trial Therapeutic Area
- Oncology|Rare Disease
- Trial Disease
- Cutaneous T-cell lymphoma | Mycosis fungoides | Sézary syndrome
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 02-04-2024
- First CTIS Authorization Date
- 30-04-2024
Trial design
open-label, none/not specified-controlled Phase II trial in France, Denmark, Greece and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 43
- Trial Duration For Participant
- 540
Eligibility
Recruits 43 Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must provide signed informed consent. Consent documentation (subject information and informed consent forms) is provided (multiple language versions listed in the trial documents). No specific information on assent or detailed vulnerable-group consent procedures is provided in the available record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must provide signed informed consent. Consent documentation (subject information and informed consent forms) is provided (multiple language versions listed in the trial documents). No specific information on assent or detailed vulnerable-group consent procedures is provided in the available record.
Inclusion criteria
- {"criterion_text":"- Males and female subjects ≥ 18 years"}
- {"criterion_text":"- Mycosis fungoides stage IB, IIA, IIB"}
- {"criterion_text":"- Subjects who have failed at least one prior course of systemic therapy. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy"}
- {"criterion_text":"- Adequate haematological and organ function"}
- {"criterion_text":"- Signed informed consent"}
Exclusion criteria
- {"criterion_text":"- Prior treatment with mogamulizumab"}
- {"criterion_text":"- Known hypersensitivity to CHO cell products or any component of the mogamulizumab formulation"}
- {"criterion_text":"- Significant uncontrolled intercurrent illness"}
- {"criterion_text":"- Prior TSEB treatment with at least one of the following conditions: • Patient has received high-dose TSEB (>30 Gray) • Patient has received TSEB ((including low-dose [12 Gray]) within 12 months before enrolment"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression Free Survival Rate, at 48 weeks after start of mogamulizumab (PFSR-48).","definition_or_measurement_approach":"Assessed according to EORTC-ISCL-USCLC criteria; main objective stated as evaluation of the progression free survival rate at 48 weeks (according to EORTC-ISCL-USCLC criteria)."}
Secondary endpoints
- {"endpoint_text":"- Overall safety of both mogamulizumab and TSEB.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Response rate (RR) to both mogamulizumab and TSEB. Time Frame: From the first patient treatment start till 48 weeks as of last patient in Proportion of patients achieving partial response or complete response according to EORTC-ISCL-USCLC criteria","definition_or_measurement_approach":"Proportion of patients achieving partial response or complete response according to EORTC-ISCL-USCLC criteria; Time frame from first patient treatment start until 48 weeks as of last patient in."}
- {"endpoint_text":"- Progression-free survival (PFS). ","definition_or_measurement_approach":""}
- {"endpoint_text":"- Overall survival (OS).","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time to progression. ","definition_or_measurement_approach":""}
- {"endpoint_text":"- Duration of response.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time to next treatment. ","definition_or_measurement_approach":""}
- {"endpoint_text":"- Exploratory endpoints: Quality of life: Skindex-29 and EORTC-QLQ-C30, and time to treatment failure.","definition_or_measurement_approach":"Quality of life assessed using Skindex-29 and EORTC-QLQ-C30; includes time to treatment failure."}
Other endpoints
- {"endpoint_text":"- Exploratory endpoints: Quality of life: Skindex-29 and EORTC-QLQ-C30, and time to treatment failure.","definition_or_measurement_approach":"Quality of life measured by Skindex-29 and EORTC-QLQ-C30; time to treatment failure as exploratory endpoint."}
Recruitment
- Planned Sample Size
- 43
- Recruitment Window Months
- 54
- Consent Approach
- Adult participants (≥18 years) must sign informed consent. Subject information sheets and ICFs are provided and documented (L1_SIS and ICF files present); consent documentation is available in multiple languages (English, French, Spanish, Greek, German, Italian, Danish as indicated by trial documents/questionnaires). No specific details on assent procedures are provided.
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 37
France
- Earliest CTIS Part Ii Submission Date
- 15-04-2024
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 708
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Dermatology
- Principal Investigator Name
- Marie Beylot-Barry
- Principal Investigator Email
- marie.beylot-barry@chu-bordeaux.fr
- Contact Person Name
- Marie Beylot-Barry
- Contact Person Email
- marie.beylot-barry@chu-bordeaux.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Dermatology
- Principal Investigator Name
- Caroline Ram-Wolff
- Principal Investigator Email
- carolineram-wolff@aphp.fr
- Contact Person Name
- Caroline Ram-Wolff
- Contact Person Email
- carolineram-wolff@aphp.fr
Denmark
- Earliest CTIS Part Ii Submission Date
- 15-04-2024
- Latest Decision Or Authorization Date
- 13-02-2026
- Processing Time Days
- 669
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Copenhagen University Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Lena Specht
- Principal Investigator Email
- lena.specht@rh.regionh.dk
- Contact Person Name
- Lena Specht
- Contact Person Email
- lena.specht@rh.regionh.dk
Greece
- Earliest CTIS Part Ii Submission Date
- 15-04-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 672
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- University General Hospital Attikon
- Department Name
- Dermatology
- Principal Investigator Name
- Evangelia Papadavid
- Principal Investigator Email
- epapad@med.uoa.gr
- Contact Person Name
- Evangelia Papadavid
- Contact Person Email
- epapad@med.uoa.gr
Italy
- Earliest CTIS Part Ii Submission Date
- 15-04-2024
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 709
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Dermatology
- Principal Investigator Name
- Pietro Quaglino
- Principal Investigator Email
- pietro.quaglino@unito.it
- Contact Person Name
- Pietro Quaglino
- Contact Person Email
- pietro.quaglino@unito.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Hematology
- Principal Investigator Name
- Alessandra Tucci
- Principal Investigator Email
- alessandra.tucci@asst-spedalicivili.it
- Contact Person Name
- Alessandra Tucci
- Contact Person Email
- alessandra.tucci@asst-spedalicivili.it
Spain
- Earliest CTIS Part Ii Submission Date
- 15-04-2024
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 679
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Dermatology
- Principal Investigator Name
- Pablo Ortiz Romero
- Principal Investigator Email
- pablo.ortiz@salud.madrid.org
- Contact Person Name
- Pablo Ortiz Romero
- Contact Person Email
- pablo.ortiz@salud.madrid.org
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Radiation Oncology
- Principal Investigator Name
- Beatriz Gil Haro
- Principal Investigator Email
- bgilh@salud.madrid.org
- Contact Person Name
- Beatriz Gil Haro
- Contact Person Email
- bgilh@salud.madrid.org
Germany
- Earliest CTIS Part Ii Submission Date
- 15-04-2024
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 744
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Universitaetsklinikum Mannheim GmbH
- Department Name
- Dermatology, Venerology and Allergology
- Principal Investigator Name
- Jan Nicolay
- Principal Investigator Email
- jan.nicolay@umm.de
- Contact Person Name
- Jan Nicolay
- Contact Person Email
- jan.nicolay@umm.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Poliklinik für Dermatologie und Allergologie
- Principal Investigator Name
- Dirk Tomsitz
- Principal Investigator Email
- dirk.tomsitz@med.uni-muenchen.de
- Contact Person Name
- Dirk Tomsitz
- Contact Person Email
- dirk.tomsitz@med.uni-muenchen.de
- Site Name
- Johannes Wesling Klinikum Minden
- Department Name
- University Clinic for Dermatology, Venerology, Allergology, and Phlebology
- Principal Investigator Name
- Rudolf Stadler
- Principal Investigator Email
- rudolf.stadler@ruhr-uni-bochum.de
- Contact Person Name
- Rudolf Stadler
- Contact Person Email
- rudolf.stadler@ruhr-uni-bochum.de
Sponsor
Primary sponsor
- Full Name
- European Organisation For Research And Treatment Of Cancer
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Belgium
Third parties
- {"country":"United Kingdom","full_name":"Klinikos Limited","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Hospital Universitario 12 De Octubre","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Spain","full_name":"Hospital Universitario Fundacion Jimenez Diaz","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Spain","full_name":"Hospital Universitario Puerta De Hierro De Majadahonda","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Luxembourg","full_name":"Luxembourg Institute Of Health","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- MOGAMULIZUMAB
- Active Substance
- MOGAMULIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised (EU MA number EU/1/18/1335/001, Poteligeo)
- Orphan Designation
- Yes
- Maximum Dose
- 40 mg/Kg
- Combination Treatment
- Yes
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