Hemotrial Un proyecto de SEHH

Ensayo clínico

A Phase II, Single Arm, Open label Study of Cyclophosphamide, Vincristine, Liposomal Doxorubicine (Myocet™) and Prednisone plus Rituximab in Fortnightly Regimen (R-COMP-14), as First Line of therapy for Patients with Aggressive Non Hodgkin’s Lymphoma (NHL).

  • Guardar


A Phase II, Single Arm, Open label Study of Cyclophosphamide, Vincristine, Liposomal Doxorubicine (Myocet™) and Prednisone plus Rituximab in Fortnightly Regimen (R-COMP-14), as First Line of therapy for Patients with Aggressive Non Hodgkin’s Lymphoma (NHL).


Resumen

2017-03-15 03:55:27
2004-001199-37
GOTEL-2003
A Phase II, Single Arm, Open label Study of Cyclophosphamide, Vincristine, Liposomal Doxorubicine (Myocet™) and Prednisone plus Rituximab in Fortnightly Regimen (R-COMP-14), as First Line of therapy for Patients with Aggressive Non Hodgkin’s Lymphoma (NHL).
GOTEL-2003

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
(GOTEL) Grupo Oncológico para el tratamiento y estudio de los linfomas Spain

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test Myocet
Cephalon Pharma SLU cyclophosphamide
Powder and solvent for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

CN 919183 Doxorrubicina l

Concentración del fármaco:

mg/m2 milligram equal

50

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Test
Vincristine
Intravenous infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

RITUXIMAB

Concentración del fármaco:

mg/m2 milligram equal

750

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
Prednisone
Intravenous infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

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 4:
Test
Rituximab
Buccal tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

100

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
Intravenous infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

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

Information no disponible en EudraCT
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Linfomas y otros Síndromes Linfoproliferativos

Dose-dense modified R-CHOP regimen (R-COMP) in patients with aggressive NHL.


To evaluate the overall response rate of R-COMP regimen as first line of treatment for patients with aggressive NHL.

To evaluate the duration of response, disease free survival and overall survival of R-COMP-14 as first line of therapy for patients with aggressive NHL.To evaluate the safety and tolerability of R-COMP-14 regimen as first line of treatment for patients with aggressive NHL.

No


• New diagnosticated patients with diffuse Large B-Cell Lymphoma (DLBCL), and their morphologic variants according to OMS classification• At least one measurable lesion is mandatory• CD20 + Lymphoma• Age of ? 18 and ? 70 years• Clinical stage at diagnosis: I or II (IPI ? 1), III or IV.• ECOG performance status 0-2• Absolute neutrophil count (ANC) ?1.5x109/L, and platelet count ?100x109/L (unless both are attributed directly to bone marrow involvement by lymphoma or auto-immune disease secondary to lymphoma) • Serum creatinine ? 2mg/dlL; serum bilirubin ?2 mg /dl; (AST/GOT)/(ALT/GPT)/AP ?5xULN, (unless the increase is attributed directly to the presence of tumour by the Investigator) • Normal ECG; Left ventricular ejection fraction (LVEF) ?50% • Written informed consent given • Patients of childbearing potential must agree to use adequate contraception for the duration, and for 3 months after the completion of the treatment.

• Clinical stage I or II if IPI = 0.• Indolent lymphoma transformed in more aggressive histological type, even if never previously treated • Mantle Cell Lymphoma, Peripheral T cell Lymphoma and their variants• Aggressive non-Hodgkin’s lymphoma in transplanted patient • Clinically significant secondary cardiovascular disease e.g. uncontrolled hypertension, uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV • Evidence of any severe active acute or chronic infection (including VIH, HbsAg or HCV)• Concurrent malignancy or history of other malignancy, except properly tretated carcinoma of the skin non-melanoma, in-situ cervical carcinoma or Myelodysplastic syndrome • Inability to comply with study procedures or to understand the study significance.• Prior CNS lymphoma • History of allergic reaction to anthracyclines, eggs (or derivatives) or known sensitivities, or history of unusual reaction, to other components of, or treatments similar to, the investigational treatment regimen • Pregnant women or breast feeding womens• Participation in a study with an investigational drug within 30 days prior to study entry.• Previous treatment with anthracyclines and/or thoracic radiotherapy for any neoplasia.

To evaluate antitumoral activity expressed as overall response rate in patients with agressive non-Hodgkin's lymphoma treated with R-COMP and bone marrow support every 14 days.

Fase IV
  DISEÑO DEL ENSAYO:

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT
  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
4
  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:


75

Para estudios internacionales:


75
75

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha