Hemotrial Un proyecto de SEHH

Ensayo clínico

A multicentre, phase III, open-label, randomized study in patients with advanced follicular lymphoma evaluating the benefit of maintenance therapy with rituximab (Mabthéra® ) after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy.

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A multicentre, phase III, open-label, randomized study in patients with advanced follicular lymphoma evaluating the benefit of maintenance therapy with rituximab (Mabthéra® ) after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy.


Resumen

2017-03-15 03:55:43
2004-001756-36
A multicentre, phase III, open-label, randomized study in patients with advanced follicular lymphoma evaluating the benefit of maintenance therapy with rituximab (Mabthéra® ) after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy.
PRIMA

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
GELA (Groupe d'Etude du Lymphome de l'Adulte) France

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test MABTHERA
ROCHE 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

Follicular lymphoma


To evaluate in patients with advanced follicular lymphoma the benefit of maintenance therapy with rituximab after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy

To evaluate response rates, event driven survival endpoints (Event Free Survival, Progression Free Survival, Overall Survival) and quality of life of four different chemotherapy regimens combined with rituximab, with or without maintenance with rituximab, for first line treatment of advanced stage follicular lymphoma.

Information no disponible en EudraCT


Histologically confirmed follicular lymphoma grade 1, 2 or 3a (biopsy ? 4 months). - Patients previously untreated.- Bulky disease at study entry according to the GELF criteria:- Age must be > 18 years.- Performance status < 2 on the ECOG scale (see appendix E1).- Adequate hematological function (unless those abnormalities are related to lymphoma extension) within 28 days prior to registration, including:• Hemoglobin ? 8.0 g/dL (5.0 mmol/L)• Absolute neutrophil count (ANC) ? 1.5 109/L• Platelet count ? 100 109/L- Women are not breast feeding, are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter. Men agree not to father a child during participation in the trial and during the 12 months thereafter.- Having previously signed a written informed consent form.

- Transformation to high-grade lymphoma (secondary to “low-grade” follicular lymphoma).- Grade 3b follicular lymphoma.- Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis).- Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to < 20 mg/day prednisone. - Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer. - Major surgery (excluding lymph node biopsy) within 28 days prior to registration.- Poor renal function: Serum creatinine > 2.0 mg/dL (197 ?mol/L),- Poor hepatic function: total bilirubin > 2.0 mg/dL (34 ?mol/L), AST (SGT) > 3 x the upper limit of normal unless these abnormalities are related to lymphoma.- Known HIV infection or active HBV or HCV infection ? 4 weeks at registration.- Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease). Judgment is up to the investigator. - Life expectancy < 6 months- Known sensitivity or allergy to murine products- Treatment within a clinical trial within 30 days prior to trial entry- Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent.

Event Free Survival (EFS) defined as the time from randomization to progression, relapse, death from any cause, or requirement of a new treatment whatever the reason.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
No

Si
No

Si

Centros participantes:


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

5
6
  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:


170

Para estudios internacionales:


540
640

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha