Hemotrial Un proyecto de SEHH

Ensayo clínico

First line treatment with Rituximab asociated to CVP plus Interferon in Follicular Lymphoma. Phase II study.Asociación de Rituximab al esquema CVP + Interferón en el tratamiento de primera línea del linfoma folicular

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First line treatment with Rituximab asociated to CVP plus Interferon in Follicular Lymphoma. Phase II study.Asociación de Rituximab al esquema CVP + Interferón en el tratamiento de primera línea del linfoma folicular


Resumen

2017-03-15 03:58:11
2005-004761-42
LNH-Pro-05
First line treatment with Rituximab asociated to CVP plus Interferon in Follicular Lymphoma. Phase II study.Asociación de Rituximab al esquema CVP + Interferón en el tratamiento de primera línea del linfoma folicular
R-CVP-IFN
LNH-Pro-05

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Fundacion Leucemia y Linfoma Spain

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test MabThera®
Roche Registration Limited, 40 Broadwater Road, We MabThera®
Concentrate for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg/ml milligram equal

10

Contenido del fármaco


No
Si

No
Information no disponible en EudraCT

No
Si

Information no disponible en EudraCT
Information no disponible en EudraCT

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

Untreated grade 1 and 2 Follicular Lymphoma


The main objective of this study is to evaluate the Progression Free Survival (PFS) in Lymphoma patients who receive CVP + Inteferon a-2b + Rituximab as first line treatment

Secondary endpoints in this study are to evaluate:- objective Response Rates- Overall Survival (OS) and Overall Specific Survival (OSS)- Molecular remission and follow-up of Minimal Residual Disease (MRD).- Safety and Tolerability of the combination

Information no disponible en EudraCT


- Age ?18 and ? 75 years.- Grade 1 or 2 Follicular Lymphoma, Marginal Zone Lymphoma or Lymphocitic Lymphoma (with no CLL criteria) confirmed by nodal tissue. Patients with diagnosis made in bone marrow trephine will be accepted, if no adenopathy is detected and MCL or CLL are ruled out.- Follicular Lymphoma International Prognostic Index (FLIPI) ? 2.- No prior chemotherapy of radiotherapy. Local radiation is accepted.- Adequate hepatic and renal function (acceted if related to LNH infiltration)- Correct Thyroid function- ECOG performance status 0 to 3.- Abscence of other malignancies or impariment to receive thge drugs in the study.- Signed approved informed consent before any study specific procedures are performed.

- Prior chemotherapy of radiotherapy. - Active second malignancy in the previous 5 years. - Previous Psiquiatric disease, specially moderate to severe depression, psycosis, autolytic attempts.- Uncontrolled current cardiopathy (myocardial infarction, angina, significant cardiac arrythmia or congestive heart failure)- Diabetes mellitus insulin requirement.- Uncontrolled hepatic or autoimmune disease.- Female subjects who are breast-feeding- Female subjects, who are not surgically sterile or post-menopausal, and do not use medically acceptable methods of birth control for the duration of the study and for one year after the last dose.- Acute or ongoing chronic infectious disease.- Immunocopromised subjects including subjects known to be HIV possitive or acute/chronic HCV or HBV positive.

The main end point of this study is to evaluate the Progression Free Survival (PFS) in Lymphoma patients who receive CVP + Inteferon a-2b + Rituximab as first line treatment.

Fase II
  DISEÑO DEL ENSAYO:

Si
No

Si
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Si
  COMPARADOR DEL ENSAYO CONTROLADO:

Information no disponible en EudraCT
Information no disponible en EudraCT

Si
No

Si

Centros participantes:


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


79
  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:


50

Para estudios internacionales:



Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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