E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rollover study supporting all indications from prior Romidepsin protocols eligible for participation in this study. Estudio de extensión que recoge todas las indicaciones de protocolos anteriores de romidepsina elegibles para participación en este estudio. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10001414 |
E.1.2 | Term | Adult T-cell lymphomas/leukaemias |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042971 |
E.1.2 | Term | T-cell lymphoma |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042979 |
E.1.2 | Term | T-cell lymphoma recurrent |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042980 |
E.1.2 | Term | T-cell lymphoma refractory |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042981 |
E.1.2 | Term | T-cell lymphoma stage I |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042982 |
E.1.2 | Term | T-cell lymphoma stage II |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042983 |
E.1.2 | Term | T-cell lymphoma stage III |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042984 |
E.1.2 | Term | T-cell lymphoma stage IV |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10002450 |
E.1.2 | Term | Angioimmunoblastic T-cell lymphomas |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10022704 |
E.1.2 | Term | Intestinal T-cell lymphomas |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10034622 |
E.1.2 | Term | Peripheral T-cell lymphomas NEC |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10042988 |
E.1.2 | Term | T-cell unclassifiable lymphomas |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10001414 |
E.1.2 | Term | Adult T-cell lymphomas/leukaemias |
|
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 |
The primary objective is to allow access to romidepsin for subjects who received romidepsin in other trials and for subjects whom the investigator feels may benefit from continuing treatment with romidepsin.
El objetivo principal es permitir el acceso a romidepsina a pacientes que recibieron romidepsina en otros ensayos clínicos y a pacientes cuyo investigador opina que se pueden beneficiar de continuar tratamiento con romidepsina. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective of the study is to evaluate the safety of intravenous infusion of romidepsin in subjects who received romidepsin in other trials.
El objetivo secundario del estudio es evaluar la seguridad de la infusión intravenosa de romidepsina en pacientes que recibieron romidepsina en otros ensayos clínicos. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Deben haber participado anteriormente y cumplido los criterios de inclusión y exclusión en alguno de los estudios clínicos de romidepsina descritos en la sección 7.1 2. El médico opina que continuar con tratamiento de romidepsina es beneficioso para el paciente. 3. Debe entender y firmar voluntariamente un formulario de consentimiento informado antes de que se realice ningún procedimiento o evaluación relativa al estudio. 4. Ser capaz de someterse al programa de visitas del estudio y otros requisitos del protocolo. 5. Prueba sérica o de orina de embarazo negativa para MEF, y 6. Todas las MEF deben utilizar un método anticonceptivo eficaz (un dispositivo intrauterino (DIU) o un método anticonceptivo doble utilizando preservativos y un diafragma más espermicida) durante el periodo de tratamiento y durante al menos 1 mes después de la finalización del mismo. Los pacientes varones deben utilizar anticonceptivos durante el periodo de tratamiento y durante al menos 3 meses a partir de la finalización del mismo.. Las pacientes deben evitar el uso de anticonceptivos que contengan estrógeno, ya que la romidepsina puede reducir la efectividad de los anticonceptivos que contengan estrógeno. Un ensayo de unión in vitro determinó que romidepsina compite con el ?-estradiol para unirse a los receptores de estrógeno. |
|
E.4 | Principal exclusion criteria |
1. Uso concomitante de fármacos que pueda causar una prolongación significativa del QTc 2. Uso concomitante de inhibidores potentes de CYP3A4 en el plazo de 1 semana anterior a la toma de la medicación de estudio en este ensayo. 3. Uso concomitante de warfarina debido a una potencial interacción entre estos fármacos. Sin embargo está permitido el uso de una dosis baja de warfarina u otro anticoagulante como profilaxis de la trombosis en las vías para acceso venoso permanente. 4. Quimioterapia o radioterapia previa o cualquier agente en investigación tras la última dosis de romidepsina del estudio anterior. 5. Las pacientes que estén embarazadas o lactantes |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is safety (type, frequency, severity and relationship of adverse events to study drug). La variable principal es la seguridad (tipo, frecuencia, gravedad y relación de las reacciones adversas con la medicación del estudio). |
|
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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | Information not present in EudraCT |
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 |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
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 | 5 |
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 |