Hemotrial Un proyecto de SEHH

Ensayo clínico

Treatment with R-MegaCHOP and early rescue with R-IFE and autologous stem cells transplant (ASCT) according response measured by positron emission tomography (PET) in patients with diffuse large B-cell lymphoma (DLBCL) with severe prognosis.

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Resumen

2017-03-15 04:02:00
2006-005254-68
GEL/TAMO-2006
Treatment with R-MegaCHOP and early rescue with R-IFE and autologous stem cells transplant (ASCT) according response measured by positron emission tomography (PET) in patients with diffuse large B-cell lymphoma (DLBCL) with severe prognosis.
GEL/TAMO-2006
GEL/TAMO-2006

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
GEL/TAMO (Cooperative Spanish Group of Lymphoma/Autologous bone marrow transplant). Spain

Fármacos

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

Contenido del fármaco


No
Si

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

Si
  FÁRMACO 2:
Test
CICLOFOSFAMIDA
Solution for infusion
Intravenous use

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 3:
Test
ADRIAMICINA (DOXORUBICINA)
Concentrate for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

RITUXIMAB

Concentración del fármaco:

mg/m2 milligram equal

375

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 4:
Test
VINCRISTINA
Powder and solvent for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

Cyclophosfamide

Concentración del fármaco:

mg/m2 milligram equal

1500

Concentración del fármaco:

mg/m2 milligram equal

1.4

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 5:
Test
PREDNISONA
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg/m2 milligram equal

65

Concentración del fármaco:

mg/m2 milligram equal

60

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Terapia Celular, Linfomas y otros Síndromes Linfoproliferativos, Trasplante Hematopoyético

Diffuse Large B-Cell Lymphoma (DLBCL)


To evaluate the event free survival (being event definite as death caused by any event, relapse or disease progression) at three years in patients with DLBCL (REAL/OMS) classification with IPI adjusted to the age >1 or a-IPI=1 and a high Betha2 microglobulin up to or equal 3mg/dl: In patients with positive PET after three cycles of R-MegaCHOP and early rescue treatment con R-IFE + TAPH In patients with negative PET after three cycles of chemotherapy treated with R-MegaCHOP followed by three cycles of R-MegaCHOP without TAPH.

-evaluate the overall survival after three years. -determine the rate of global responses and complete remisions, uncertain and partial. -determine the duration of the complete response after the treatment termination. -carry out an exploratoy follow up of the event free survival and the overall survival at 5 years. -evaluate the treatment toxicity according CTC criteria (version 3.0) of the National Cancer Institute (NCI). -asses the role of PET in the disease stage and response evaluation compared to CAT. -identify the predictable reponse factors after 6 cycles of treatment with R-MegaCHOP administrated every 21 days; or 3 cycles of R-MegaCHOP, followed by IFE+TAPH in patients with DLBCL of severe prognosis. -evaluate the therapeutic fulfillment of the R-MegaCHOP and R+IFE cycles of treatment and/or R-IFE in reference with delays with the cycles administration and reductions of the chemotherapy dose (planned dose administrated in the planned term).

No


1. folicular lymphoma grade III diagnosed patients, diffuse large B-cell lymphoma, hystologically confirmed with CD20+ 2. aged between 18 and 65 years. Pacients aged from 65 to 70 years can be included according to the investigator's criteria regarding the patients' global health status and the absence of excluding comorbility. 3. IPI adjusted to the age over 1 or a-IPI and beta2-microbloguline equal or higher than 3 mg/dl 3. Punctuation in the ECOG grade from 0 to 4 4. Life expectancy over 12 weeks 5. Writen informed consent form 6. New diagnosed patient without any previous treatment

1. Existence of severe cardiac, pulmonar, neurologic, psiquiatric and metabolic diseases not caused by the lymphoma. 2. uncontrolled high blood pressure (diastolic pressure in rest > 115 mmHg) 3. Altered hepactic function (bilirrubine or AST/ALT superior or equal at 2 times the superior limit of normality) or renal (cratinine equal or superior at 1.5 times the superior limit of normality) not caused by the lymphoma. 4. other malignant neoplasies along the past 5 years, except skin tumours, excluded melanoma or carcinoma in situ of cervix 5. patients positive for HIV 6. patients with transformed folicular lymphoma 7. pregnant women or in nursing; women of childbearing age who do not use an adecuate contraceptive method before being included in the study 8. ventricular ejection fraction inferior to 50% 9. patients with severe psiquiatric diseases which can interfere with their ability for understanding the study (including alcoholism or drug addiction)

The principal end point is the valoration of the event free survival (EFS) three years later

Fase IV
  DISEÑO DEL ENSAYO:

No
No

No
No

No
No

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

Si

Centros participantes:


No
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:


250

Para estudios internacionales:



Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha

Inicial