E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Classic Hodgkin lymphoma and T-cell lymphoma with CD30 expression |
Linfoma de Hodgkin clásico y linfoma T con expresión CD30 |
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E.1.1.1 | Medical condition in easily understood language |
Classic Hodgkin lymphoma and T-cell lymphoma with CD30 expression |
Linfoma de Hodgkin clásico y linfoma T con expresión CD30 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
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 evaluate the safety and toxicity of the administration of autologous, mature, ex vivo expanded and genetically modified T lymphocytes with a chimeric antigen-specific receptor (CAR) directed against the CD30 antigen. |
Evaluar la seguridad y toxicidad de la administración de linfocitos T autólogos, maduros, expandidos ex vivo y modificados genéticamente con un receptor quimérico antígeno-específico (CAR) dirigido frente al antígeno CD30. |
|
E.2.2 | Secondary objectives of the trial |
- Analyze the implant and persistence of T-CAR30 cells. - Analyze the rate of complete answers at 3 months of the procedure, using PET-CT. - Analyze the impact of the procedure on 1-year progression-free survival. |
- Analizar el implante y persistencia de las células T-CAR30. - Analizar la tasa de respuestas completas a los 3 meses del procedimiento, mediante PET-TC. - Analizar el impacto del procedimiento en la supervivencia libre de progresión a 1 año. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with classic Hodgkin's disease: - Age between 18-70 years inclusive. - Patients in relapse after an autologous hemopoietic stem cell transplant and who have previously received brentuximab and anti-PDL1 antibodies in some of the rescue treatments, without reaching RC. - Patients who are primarily refractory (after the 1st line of treatment) and who do not reach RC after rescue treatments that include brentuximab and anti-PDL1 antibodies.
Patients with anaplastic large cell lymphoma T (ALK + and ALK -) and peripheral T lymphoma (NOS and angioimmunoblastic): - Expression of CD30 (determined by immunohistochemistry) in> 90% of tumor cells for peripheral T-lymphoma. - Age between 18-70 years inclusive. - Patients in relapse after an autologous hemopoietic stem cell transplant. - Patients who are primarily refractory (after the 1st line of treatment that includes anthracycline) who do not achieve CR after rescue chemotherapy (ESHAP, ICE, DHAP, Gemex, or brentuximab vedotin). |
Pacientes con enfermedad de Hodgkin clásico: - Edad entre 18-70 años inclusive. - Pacientes en recidiva tras un trasplante autólogo de progenitores hemopoyéticos y que hayan recibido previamente brentuximab y anticuerpos anti-PDL1 en alguno de los tratamientos de rescate, sin alcanzar RC. - Pacientes primariamente refractarios (tras 1ª línea de tratamiento) y que no alcancen RC tras tratamientos de rescate que incluyan brentuximab y anticuerpos anti-PDL1.
Pacientes con linfoma T anaplásico de célula grande (ALK + y ALK -) y linfoma T periférico (NOS y angioinmunoblástico): - Expresión de CD30 (determinado por inmunohistoquímica) en > 90% de las células tumorales para el linfoma T periférico. - Edad entre 18-70 años inclusive. - Pacientes en recidiva tras un trasplante autólogo de progenitores hemopoyéticos. - Pacientes primariamente refractarios (tras 1ª línea de tratamiento que incluya antraciclina) que no alcancen una RC tras quimioterapia de rescate (tipo ESHAP, ICE, DHAP, Gemex, o brentuximab vedotina). |
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E.4 | Principal exclusion criteria |
- General condition determined according to the ECOG scale: 2-4 - Previous allogeneic hemopoietic transplant - Active infection by HBV or HCV. - HIV infection. - Bacterial, fungal or viral active infection. - Active infiltration of the CNS by lymphoma. Previous infiltration by lymphoma is not exclusive if there is evidence of absence of disease in the CNS prior to treatment. - Abnormal renal and hepatic functions, with a creatinine and / or bilirubin figure 2 and 3 times higher than the normal limit value, respectively, except when the alterations are attributable to the lymphoma (only in case of hepatic alliteration). - Patients with decreased ejection fraction (less than 45%), symptomatic heart failure, or both. - Presence of cirrhosis or active hepatitis due to HBV or HCV virus. - Patients with concomitant severe neurological or psychiatric disease. - Presence of active autoimmune or rheumatological disease that requires systemic treatment with any immunosuppressant (including prednisone at any dose). - Pneumopathy of any kind that conditions a DLC <50% - Major surgery in the 6 weeks prior to the start of inclusion. - Any concomitant antineoplastic treatment. - Pregnancy. |
- Estado general determinado según escala ECOG: 2-4 - Trasplante hemopoyético alogénico previo - Infección activa por VHB ó VHC. - Infección por VIH. - Infección bacteriana, fúngica o vírica activa. - Infiltración activa del SNC por linfoma. La infiltración previa por linfoma no es excluyente si existe demostración de ausencia de enfermedad en el SNC previa al tratamiento. - Funciones renal y hepática anormales, con cifra de creatinina y/o bilirrubina 2 y 3 veces superior al valor límite normal, respectivamente, excepto cuando las alteraciones sean atribuibles al linfoma (solo en caso de la aliteración hepática). - Pacientes con fracción de eyección disminuida (inferior al 45%), insuficiencia cardiaca sintomática, o ambas. - Presencia de cirrosis o hepatitis activa por virus VHB o VHC. - Pacientes con enfermedad neurológica o psiquiátrica grave concomitante. - Presencia de enfermedad autoinmune ó reumatológica activa que requiera tratamiento sistémico con cualquier inmunosupresor (incluido prednisona a cualquier dosis). - Neumopatía de cualquier tipo que condiciones una DLC < 50% - Cirugía mayor en las 6 semanas previas al inicio de la inclusión. - Cualquier tratamiento antineoplásico concomitante. - Pacientes embarazadas. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
-Dose-limiting dose -Security -Response |
-Toxicidad limitante de dosis -Seguridad -Respuesta |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Time to event |
Hasta que ocurra |
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E.5.2 | Secondary end point(s) |
-Implant and persistence of HSP-CAR30 cells. -Free progression survival. -Global survival |
-Implante y persistencia de células HSP-CAR30. -Supervivencia libre de progresión. -Supervivencia global |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Time to event |
Hasta que ocurra |
|
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 | 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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
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.8.3 |
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 | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
|
LVLS |
Ultima visita del último paciente incluido |
|
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 | |
E.8.9.1 | In the Member State concerned days | |