Hemotrial Un proyecto de SEHH

Ensayo clínico

A Multicenter, Open, Phase II Study to Estimate the activity and safety of Caspofungin (CASP) in the First-line Treatment of probable and proven Invasive Aspergillosis 'IA) in Patients with Hematological Malignances (HM) or recipients of autologous Haematopoietic Stem Cell Transplantation and those with allogeneic Haematopoietic Stem Cell Transplantation (HSCT)

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Resumen

2017-03-15 03:56:08
2004-002944-90
EORTC 65041
A Multicenter, Open, Phase II Study to Estimate the activity and safety of Caspofungin (CASP) in the First-line Treatment of probable and proven Invasive Aspergillosis 'IA) in Patients with Hematological Malignances (HM) or recipients of autologous Haematopoietic Stem Cell Transplantation and those with allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
Caspo trial
EORTC 65041

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
European Organisation for Research and Treatment of Cancer Belgium

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test CANCIDAS
Merck Sharp & Dohme Limited Coaspofungin Acetate
MK-0991 Powder for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):
MK-0991 Caspofungin Ace

Concentración del fármaco:
mg milligram(s) equal

50

Contenido del fármaco

Si
Si

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

Si
  FÁRMACO 2:
Test CANCIDAS
Merck Sharp & Dohme Limited Coaspofungin Acetate
MK-0991 Powder for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):
MK-0991 Caspofungin Ace

Concentración del fármaco:
mg milligram(s) equal

70

Contenido del fármaco

Si
Si

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

Si
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General

Terapia Celular, Trasplante Hematopoyético

Invasive aspergillosis in patients with haematological malignancies (HM)/autologous Hematopoietic Stem Cell Transplantation (HSCT) – group A- and patients with allogeneic HSCT transplantation – group B

The primary objective of this trial is to estimate the activity of caspofungin as first line therapy in the treatment of Invasive aspergillosis in patients with haematological malignancies (HM)/autologous Hematopoietic Stem Cell Transplantation (HSCT) – group A- and patients with allogeneic HSCT transplantation – group B. The activity of caspofungin will be assessed separately in these two groups of patients since response rates and survival differ substantially in these 2 patient populations.


Information no disponible en EudraCT


- Patients eligible for this study will be patients 18 years of age or olderwith HM/auto-HSCT or allo-HSCT and with a diagnosis of proven orprobable IA, according to EORTC-MSG criteria. All patients must befollowed in centers belonging to the EORTC network.- The inclusion of patients with possible IA will be allowed. However, study drug treatment should be stopped if the case cannot be upgraded to probable or proven IA within 7 days after enrolment, based on tests already performed prior to or within 48 hrs after registration into the study, but with pending results. These include culture and/or histology results and Aspergillus galactomannan evaluations.- A course of no more than 72 hours of empirical antifungal therapy, not including an echinocandin, prior to enter into the study will be allowed.- Oral antifungal prophylaxis is allowed, but prophylaxis must be discontinued at study entry.- Intravenous fluconazole for prophylaxis is allowed, but prophylaxis must be discontinued at study entry.- Absence of a history of allergy or any adverse reaction to echinocandin drugs- Absence of severe renal failure requiring hemodialysis or peritoneal dialysis and a serum creatinine level lower than 300 µmol/L or 3.4 mg/dL- Absence of significant liver function test abnormalities, defined as an increase in ASAT/ALAT higher than 5x upper normal limits (UNL) or total serum bilirubin/ALP 5xUNL.- Patients with severe hepatic insufficiency are excluded- Karnofski performance status score ? 20. Comatose and moribund patients or those who have little hope of recovery are excluded- Absence of known bacterial infection not adequately treated at time of enrolment- Pregnant and lactating women are excluded. Women of child bearing potential should have a negative pregnancy test within 7 days from registration.- Patients receiving an investigational agent within 14 days prior to study entry or during the study course will be excluded.- Absence of documented HIV infection- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.- Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.


The primary endpoint of the study will be the response rate at the end of caspofungin therapy using the standard response assessment criteria as defined in the protocol.

Fase II
  DISEÑO DEL ENSAYO:

No
No

No
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:

2
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:

20

Para estudios internacionales:

135
149

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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