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Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio de fase III, abierto, multicéntrico y de un solo brazo, del retratamiento con galiximab en combinación con rituximab en sujetos con linfoma no Hodgkin folicular en recidiva que han respondido previamente en el Estudio 114-NH-301A Phase III, Open-Label, Multicenter, Single-Arm, Retreatment Study of Galiximab in Combination with Rituximab for Subjects with Relapsed, Follicular Non-Hodgkin’s Lymphoma who Previously Responded on Study 114-NH-301

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Resumen

2017-03-15 04:01:10
2006-003987-74
114-NH-302
Estudio de fase III, abierto, multicéntrico y de un solo brazo, del retratamiento con galiximab en combinación con rituximab en sujetos con linfoma no Hodgkin folicular en recidiva que han respondido previamente en el Estudio 114-NH-301A Phase III, Open-Label, Multicenter, Single-Arm, Retreatment Study of Galiximab in Combination with Rituximab for Subjects with Relapsed, Follicular Non-Hodgkin’s Lymphoma who Previously Responded on Study 114-NH-301
114-NH-302

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Biogen Idec Ltd. United Kingdom

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
Galiximab
I Concentrate for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

Galiximab IDEC 114, anti-

Concentración del fármaco:

mg/ml milligram equal

50

Contenido del fármaco


No
Si

No
Information no disponible en EudraCT

No
Si

No
No

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Linfomas y otros Síndromes Linfoproliferativos

Linfoma no Hodgkin folicular en recidivaRelapsed, Follicular Non-Hodgkin’s Lymphoma


To assess the safety of repeat or initial treatment with galiximab in combination with rituximab after relapse in the pivotal Phase III study (114-NH-301)

To further characterize the pharmacokinetics (PK) of repeat or initial treatment with galiximab in combination with rituximabTo further characterize the efficacy profile of galiximab in combination with rituximab

No


To be considered for registration and randomization into this study, subjects must satisfy all of the following criteria:1. Must give written informed consent and any authorizations as required by local law (e.g., Protected Health Information [PHI] for North America)2. Demonstrated a response (CR, CRu, or PR) on Study 114-NH-301 and then relapsed or progressed with a TTP ?6 months. Relapsed disease is defined as documented disease progression using the International Workshop Response Criteria (IWRC) as described in Appendix C of the protocol3.Bidimensionally measurable disease with at least 1 lesion ?2.0 cm in a singledimension4.Hematologic, hepatic and renal function parameters satisfying the following:a. Bilirubin ?2.0 mg/dLb. AST (SGOT) ?2 X upper limit of normal (ULN) and ALT (SGPT) ?2 X ULNc. Serum creatinine ?2.0 mg/dLd. Hemoglobin ?8.0 g/dLe. Absolute neutrophil count ?1500 cells/mm3f. Platelet count ?75,000 plts/mm35. WHO Performance Status ?26. Expected survival of ?3 months7. Subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment

Unless otherwise specified, candidates will be excluded from study entry if any of thefollowing exclusion criteria exist at the time of registration:1. Any lymphoma therapy between Final Visit on Study 114 NH 301 and Study Day 1 of this retreatment study2. Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 13. Transfusion-dependent subjects4. Presence of central nervous system (CNS) lymphoma5. Histologic transformation6. Presence of pleural or peritoneal effusion with positive cytology for lymphoma7. Another primary malignancy requiring active treatment 8. Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor9. New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 110. Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 111. History of alcoholism or substance abuse within the 2 years prior to Study Day 112. Pregnant or currently breastfeeding

The primary study endpoint is Progression-Free Survival (PFS).

Fase III
  DISEÑO DEL ENSAYO:

No
No

Si
No

No
No

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
No

No
No

Si

Centros participantes:


Si
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

8
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:


0
1

1

Sexo:


1
1

Número planeado de pacientes a incluir:


14

Para estudios internacionales:


125
350

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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En Marcha