E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
CLL, SLL, MCL, WM, DLBCL, FL, MZL, multiple myeloma, GvHD, pancreatic cancer, kidney cancer, bladder cancer, stomach cancer, throat cancer, colon cancer |
LLC, SII, leiomiomatosis cutánea múltiple, Macroglubulinemia de Waldenström, DLBCL, linfoma folicular, mieloma múltiple, GvHD, cáncer de páncreas, riñón, vejiga, estómago, garganta, colon |
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E.1.1.1 | Medical condition in easily understood language |
CLL, SLL, MCL, WM, DLBCL, FL, MZL, multiple myeloma, GvHD, pancreatic cancer, kidney cancer, bladder cancer, stomach cancer, throat cancer, colon cancer |
LLC, SII, leiomiomatosis cutánea múltiple, Macroglubulinemia de Waldenström, DLBCL, linfoma folicular, mieloma múltiple, GvHD, cáncer de páncreas, riñón, vejiga, estómago, garganta, colon |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10043515 |
E.1.2 | Term | Throat cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054695 |
E.1.2 | Term | Waldenstrom's macroglobulinemia |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008976 |
E.1.2 | Term | Chronic lymphocytic leukemia |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10005003 |
E.1.2 | Term | Bladder cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10076596 |
E.1.2 | Term | Marginal zone lymphoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009944 |
E.1.2 | Term | Colon cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033604 |
E.1.2 | Term | Pancreatic cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042080 |
E.1.2 | Term | Stomach cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028228 |
E.1.2 | Term | Multiple myeloma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061275 |
E.1.2 | Term | Mantle cell lymphoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029473 |
E.1.2 | Term | Nodular (follicular) lymphoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041152 |
E.1.2 | Term | Small lymphocytic lymphoma, consistent with CLL (Working Formulation) |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018799 |
E.1.2 | Term | GVHD |
E.1.2 | System Organ Class | 100000004870 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023400 |
E.1.2 | Term | Kidney cancer |
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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To provide long-term access to ibrutinib for subjects who have been enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and are deriving benefit as assessed by the treating physician |
Proporcionar a largo plazo acceso a ibrutinib a los sujetos que se hayan inscrito en estudios de ibrutinib ya finalizados de acuerdo con el protocolo principal, están recibiendo tratamiento con ibrutinib y están obteniendo beneficios según lo evaluado por el médico encargado del tratamiento. |
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E.2.2 | Secondary objectives of the trial |
Further key objective is to collect long-term safety data for these subjects treated with ibrutinib and to characterize the drug safety profile in long-term treatment with ibrutinib. |
Otro objetivo clave es recopilar datos de seguridad a largo plazo para estos sujetos tratados con ibrutinib y caracterizar el perfil de seguridad del fármaco en el tratamiento a largo plazo con ibrutinib |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject must currently be participating in an ibrutinib clinical trial, deriving clinical benefit from treatment with ibrutinib in the opinion of the treating physician and do no thave access to commercial ibrutinib within their region (eg, no regulatory approval ,insufficient reimbursement, and/or insufficient insurer coverage for the indication). 2. Ongoing continuous treatment with ibrutinib: ibrutinib treatment may be on temporary hold at the time of enrollment with less than 28 continuous doses missed, however, the decision cannot have been made to permanently discontinue ibrutinib treatment. 3. Subject must have completed all assessments in their parent protocol (eg, End-of-Treatment Visit is completed) and want to continue treatment with ibrutinib. 4.Subject has provided informed consent to the long-term treatment extension protocol and not withdrawn consent from the parent study. 5.Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control (as desribed in the protocol) during the period of therapy and for 90 days for females and males after the last dose of drug. |
1. El sujeto debe estar participando actualmente en un ensayo clínico de ibrutinib, obteniendo beneficios clínicos del tratamiento con ibrutinib en opinión del médico que lo trata y no tiene acceso a ibrutinib comercializado en su país (p. ej., no existe aprobación reglamentaria, reembolso insuficiente o cobertura del seguro insuficiente para la indicación). 2. Tratamiento continuo en curso con ibrutinib: el tratamiento con ibrutinib puede haberse suspendido temporalmente en el momento de la inscripción con menos de 28 dosis continuas omitidas, sin embargo, no se puede haber tomado la decisión de suspender permanentemente el tratamiento con ibrutinib. 3. El sujeto debe haber completado todas las evaluaciones del protocolo principal (p. ej., se ha completado la visita de fin del tratamiento) y desea continuar el tratamiento con ibrutinib. 4. El sujeto ha proporcionado el consentimiento informado para el protocolo de extensión del tratamiento a largo plazo y no ha retirado el consentimiento del estudio principal. 5. Hombres y mujeres en edad fértil que acepten usar un método anticonceptivo altamente eficaz (p. ej., implantes, inyectables, anticonceptivos orales combinados, dispositivos intrauterinos [DIU], abstinencia completa o pareja esterilizada) y un método de barrera (p. ej., preservativos, anillo cervical o esponja) durante el periodo del tratamiento y durante 90 días después de la última dosis del fármaco para hombres y mujeres. |
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E.4 | Principal exclusion criteria |
1. Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment. 2. Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject’s participation in the protocol. 3. Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this protocol or within 90 days of last dose of drug treatment. Male subjects who plan to father a child while enrolled in this protocol or within 90 days after the last dose of drug treatment. 4. Unwilling or unable to participate in all required evaluations and procedures. 5. Unable to understand the purpose and risks of the protocol and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information(in accordance with national and local subject privacy regulations). |
1. Cumple cualquier requisito en el protocolo principal para suspender permanentemente el tratamiento con ibrutinib. 2. Cualquier enfermedad o situación que, en opinión del médico que lo trate, pueda interferir significativamente con la participación de un sujeto en el protocolo. 3. Mujeres que están embarazadas o en periodo de lactancia o que están pensando quedarse embarazadas mientras estén inscritas en este protocolo o durante 90 días después de la última dosis del tratamiento con el fármaco. Hombres que planean engendrar un hijo mientras estén inscritos en este protocolo o durante 90 días después de la última dosis del tratamiento con el fármaco. 4. No está dispuesto o no puede participar en todas las evaluaciones y procedimientos requeridos. 5. Es incapaz de comprender el propósito y los riesgos del protocolo y de proporcionar un formulario de consentimiento informado (FCI) firmado y fechado y la autorización para usar información médica protegida (de acuerdo con la normativa nacional y local sobre la privacidad de los sujetos). |
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E.5 End points |
E.5.1 | Primary end point(s) |
There is no specific primary endpoint. |
No hay variable principal específica |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Not applicable. |
No aplicable |
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E.5.2 | Secondary end point(s) |
Long-term safety. |
Seguridad a largo plazo |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After the termination of the study. |
Después de la terminación del estudio |
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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 | 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 | 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) | Yes |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 120 |
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 |
Australia |
Austria |
Belgium |
Canada |
China |
Czech Republic |
France |
Germany |
Greece |
Ireland |
Israel |
Italy |
Korea, Republic of |
New Zealand |
Poland |
Russian Federation |
Spain |
Sweden |
Turkey |
Ukraine |
United States |
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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
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LVLS |
última visita último sujeto |
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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 | 10 |
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 | 10 |
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 |