E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cutaneous T-cell lymphoma (Mycosis Fungoides (MF) and Sézary Syndrome (SS)) |
Linfoma cutáneo de células T (micosis fungoide (MF) y síndrome de Sézary (SS)) |
|
E.1.1.1 | Medical condition in easily understood language |
Cutaneous T-cell lymphoma, a category of cancers of lymphocytes (a type of white blood cells) that primarily involve the skin |
Linfoma cutáneo de células T, una categoría de cánceres de linfocitos (un tipo de glóbulos blancos) que afectan principalmente a la piel |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 22.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028502 |
E.1.2 | Term | Mycosis fungoides refractory |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 22.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028504 |
E.1.2 | Term | Mycosis fungoides stage II |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 22.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028503 |
E.1.2 | Term | Mycosis fungoides stage I |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 22.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028508 |
E.1.2 | Term | Mycosis fungoides/Sezary syndrome |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 22.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028511 |
E.1.2 | Term | Mycosis fungoides/Sezary syndrome refractory |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 22.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028512 |
E.1.2 | Term | Mycosis fungoides/Sezary syndrome stage I |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 22.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028513 |
E.1.2 | Term | Mycosis fungoides/Sezary syndrome stage II |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10025321 |
E.1.2 | Term | Lymphomas non-Hodgkin's T-cell |
E.1.2 | System Organ Class | 10005329 - Blood and lymphatic system disorders |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the progression free survival rate at 48 weeks (according to EORTC-ISCL-USCLC criteria) of anti-CCR4 monoclonal antibody (mogamulizumab) and TSEB in IB-IIB cutaneous T-cell lymphoma. |
Evaluar la tasa de supervivencia sin progresión a las 48 semanas (de acuerdo con los criterios de la EORTC-ISCL-USCLC) del anticuerpo monoclonal anti-CCR4 (mogamulizumab) y TSEB en el linfoma cutáneo de linfocitos T en estadio IB-IIB |
|
E.2.2 | Secondary objectives of the trial |
• To evaluate the overall safety • To assess the response rate • To assess the progression-free survival • To assess the overall survival • To assess the time to progression • To evaluate the duration of response • To evaluate the time to next significant treatment |
• Evaluar la seguridad general • Evaluar la tasa de respuesta • Evaluar la supervivencia sin progresión • Evaluar la supervivencia general • Evaluar el tiempo hasta la progresión • Evaluar la duración de la respuesta • Evaluar el tiempo hasta el siguiente tratamiento significativo |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Males and female subjects ≥ 18 years; • Mycosis fungoides stage IB, IIA, IIB; • 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; • Adequate haematological and organ function; • Signed informed consent |
• Hombres y mujeres de ≥18 años • Micosis fungoide en estadio IB, IIA, IIB • Pacientes que no han respondido al menos a un ciclo previo de tratamiento sistémico. El tratamiento con psoraleno y luz ultravioleta (PUVA) no se considera un tratamiento sistémico • Funcionalidad hematológica y orgánica adecuada • Consentimiento informado firmado |
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E.4 | Principal exclusion criteria |
• Prior treatment with mogamulizumab; • Prior TSEB; • Known hypersensitivity to CHO cell products or any component of the mogamulizumab formulation; • Significant uncontrolled intercurrent illness |
• Tratamiento previo con mogamulizumab • TSEB previa • Hipersensibilidad conocida a los productos de células CHO o cualquier componente de la formulación de mogamulizumab; • Enfermedad intercurrente significativa no controlada |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Progression Free Survival Rate at 48 weeks (PFSR-48) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 48 weeks after start of mogamulizumab for each patient |
Hasta 48 semanas después del inicio de mogamulizumab para cada paciente |
|
E.5.2 | Secondary end point(s) |
• Overall safety of both mogamulizumab and TSEB; • Response rate (RR) to both mogamulizumab and TSEB ; • Progression-free survival (PFS) ; • Overall survival (OS); • Time to progression ; • Duration of response ; • Time to next treatment.
Exploratory endpoints: Quality of life: Skindex-29 and EORTC-QLQ-C30, and time to treatment failure. |
• Seguridad general tanto de mogamulizumab como de TSEB • Tasa de respuesta tanto de mogamulizumab como de TSEB • Supervivencia sin progresión • Supervivencia global • Tiempo hasta la progresión • Duración de la respuesta • Tiempo hasta el siguiente tratamiento |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Overall safety: 48 months after last patient in; • RR: from the first patient treatment start till 48 weeks as of last patient in; • PFS: from the first patient treatment start till 48 weeks as of last patient in; • OS: from the first patient treatment start till 5 years after last patient treatment; • Time to progression: from the first patient treatment start till 48 weeks as of last patient in; • Duration of resp: from the first patient treatment start till 48 weeks as of last patient in; • Time to next treatment: from the first patient treatment start till 48 weeks as of last patient in. |
• Seguridad general: 48 meses después del reclutamiento del último paciente; • RR: desde el inicio del tratamiento del primer paciente hasta 48 semanas a partir del último paciente; • SLP: desde el inicio del tratamiento del primer paciente hasta 48 semanas a partir del último paciente; • SG: desde el inicio del tratamiento del primer paciente hasta 5 años después del tratamiento del último paciente; • Tiempo de progresión: desde el inicio del tratamiento del primer paciente hasta 48 semanas desde el último paciente; • Duración de la respuesta: desde el inicio del tratamiento del primer paciente hasta 48 semanas a partir del último paciente; • Tiempo hasta el siguiente tratamiento: desde el inicio del tratamiento del primer paciente hasta 48 semanas a partir del último paciente. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Radiotherapy, Biobanking, Quality of Life |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Finland |
France |
Germany |
Greece |
Italy |
Spain |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
End of study occurs when all of the following criteria have been satisfied: 1. Ninety days after all patients have stopped protocol treatment 2. The trial is mature for the analysis of the primary endpoint as defined in the protocol 3. The database has been fully cleaned and frozen for this analysis |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |