E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adult patients aged 18-80 years with previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) |
Pacientes adultos entre 18-80 años con linfoma difuso de células B grandes CD-20 positivo no tratados previamente |
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E.1.1.1 | Medical condition in easily understood language |
previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) |
linfoma difuso de células B grandes CD-20 positivo no tratados previamente |
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E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012818 |
E.1.2 | Term | Diffuse large B-cell lymphoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To estimate the efficacy in each treatment arm, as measured by complete response (CR) rate 4?8 weeks after the end of treatment. |
Estimar la eficacia de cada brazo de tratamiento, medido como grado de respuesta completa (RC) en 4-8 semanas tras la finalización del tratamiento. |
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E.2.2 | Secondary objectives of the trial |
? To compare patient satisfaction with rituximab administration (SC versus IV) in patients with DLBCL ? To evaluate event-free survival, disease-free survival, progression-free survival and overall survival from randomisation (at least 24 months of follow-up) ? To evaluate the safety of rituximab (SC versus IV) in patients with DLBCL. |
- Comparar la satisfacción con rituximab SC y rituximab IV de pacientes con linfoma difuso de células B grandes (LDCBG) - Evaluar la supervivencia sin acontecimientos (SSA), la supervivencia sin enfermedad (SSE), la supervivencia sin progresión (SSP) y la supervivencia global (SG) desde la aleatorización (al menos 24 meses de seguimiento) - Evaluar la seguridad de rituximab (SCfrente a IV) en pacientes con LDCBG |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Age ? 18 and ? 80 years at time of study inclusion ? Histologically confirmed, previously untreated CD20-positive DLBCL according to the WHO classification system ? Patients with an IPI score of 1-5 or IPI score of 0 with bulky disease, defined as one lesion ? 7.5 cm ? At least one bi-dimensionally measurable lesion defined as ? 1.5 cm in its largest dimension on CT scan ? Adequate hematologic function ? Eastern Cooperative Oncology Group (ECOG) performance status ? 2. |
- Edad ? 18 años y ? 80 años en el momento de la inclusión en el estudio - LDCBG CD20 positivo confirmado histológicamente, de acuerdo con el sistema de clasificación de la OMS, no tratado previamente - Pacientes con una puntuación en el IPI de 1-5 o una puntuación en el IPI de 0 con enfermedad voluminosa, definida como una lesión ? 7.5 cm - Al menos una lesión mensurable en dos dimensiones, definida como una dimensión máxima ? 1,5 cm en la TC o la RM - Función hematológica adecuada - Estado funcional del Eastern Cooperative Oncology Group (ECOG)? 2 |
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E.4 | Principal exclusion criteria |
? Histological evidence of transformation of NHL, or types of NHL other than follicular lymphoma ? Presence or history of CNS disease ? History of malignancy other than follicular NHL which could affect compliance with protocol or interpretation of results ? Recent major surgery (within 4 weeks prior to screening, excluding lymph node biopsy). |
- Evidencia histológica de transformación del LNH, o tipos de LNH distintos al linfoma folicular - Presencia o historia de enfermedad del SNC - Antecedentes de otros procesos malignos distintos al linfoma folicular que pudieran afectar al cumplimiento del protocolo o interpretación de resultados. - Intervención de cirugía mayor reciente (en las 4 semanas previas al inicio de la administración del fármaco del estudio salvo sbiopsia de nódulo linfático) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of CR/CRu (measured from the day of first rituximab induction dose) will be based on the Investigator?s assessment, completed according to the International Working Group response criteria (Cheson et al. 1999) at the end of induction treatment. |
El criterio de valoración principal de la tasa de respuestas completas (medida desde el día de la primera dosis de inducción de rituximab) se determinará basándose en la valoración del investigador, realizada de acuerdo con los criterios de respuesta del International Working Group (Cheson y cols. 1999) al final del tratamiento de inducción. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary analysis of response rate will take place when all patients have completed their induction treatment. |
El primer análisis del grado de respuesta tendrá lugar cuando todos los pacientes hayan completado su tratamiento de inducción. |
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E.5.2 | Secondary end point(s) |
Event-free survival, disease-free survival, progression-free survival and overall survival (EFS, DFS, PFS and OS), patient reported outcomes, administration times and a summary of safety data. |
Supervivencia libre de acontecimientos, supervivencia libre de enfermedad y supervivencia global, resultados comunicados de pacientes, tiempos de administración y un resumen de datos de seguridad |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
A preliminary analysis will be performed when all patients have completed their induction treatment. The final analysis of secondary efficacy endpoints (EFS, DFS, PFS and OS) will be provided when the last patient has completed at least 24 months of follow-up after the end of induction treatment, or when one of the following has been documented for all randomized patients: disease recurrence, withdrawal from the study, loss to follow up or death, whichever occurs first. |
Se realizará un primer análisis cuando todos los pacientes hayan completado su tratamiento de inducción. El análisis final de los criterios de valoración secundarios de eficacia se facilitarán cuando el último paciente haya completado al menos 24 meses de seguimiento tras la finalización del tratamiento de inducción , o cuando un criterio de los siguientes se haya documentado para todos los pacientes randomizados: recurrencia de la enfermedadm abandono del estudio, pérdida de seguimiento o muerte, lo que ocurra primero. |
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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 | Yes |
E.6.13 | Others | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 16 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 82 |
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 |
Algeria |
Argentina |
Belgium |
Brazil |
Bulgaria |
Canada |
Colombia |
Finland |
France |
Greece |
India |
Ireland |
Israel |
Italy |
Netherlands |
Peru |
Poland |
Portugal |
Russian Federation |
Saudi Arabia |
Serbia |
South Africa |
Spain |
Thailand |
Turkey |
Ukraine |
United Kingdom |
Venezuela, Bolivarian Republic of |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 is defined as the last patient last visit in the follow-up period. The study will end when all patients have been followed for at least 24 months after their last dose of study treatment, or earlier, if one of the following is documented for all treated patients: disease recurrence, withdrawal from the study, loss to follow up or death. |
El final del estudio se define como la visita del ultimo paciente en el periodo de segumiento. El estudio finalizará cuando a todos los pacientes se les haya hecho seguimiento de al menos 24 meses tras su última dosis del tratamiento de estudio , o antes, si una de los siguientes evidencias se documentan para todos los pacientes tratados: recurrencia de la enfermedad, abandono del estudio, pérdida de seguimiento o muerte. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |