ID

13745

Descripción

A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01055483

Link

https://clinicaltrials.gov/show/NCT01055483

Palabras clave

Versiones (1)
  1. 2/3/16 2/3/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

2 de marzo de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Acute Myeloid Leukemia NCT01055483

Inglés

Eligibility Acute Myeloid Leukemia NCT01055483

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with cytopathologically confirmed diagnosis of aml according to who criteria, excluding acute promyelocytic leukemia.
Descripción

patients with cytopathologically confirmed diagnosis of aml according to who criteria, excluding acute promyelocytic leukemia.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0456521
UMLS CUI [2]
C0023487
first relapsed aml
Descripción

first relapsed aml

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0277556
UMLS CUI [1,3]
C0205435
primary refractory aml defined as failure to respond to initial induction chemotherapy (no cr) or recurrence within 6 months of initial cr.
Descripción

primary refractory aml defined as failure to respond to initial induction chemotherapy (no cr) or recurrence within 6 months of initial cr.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0205269
age more than 18 years
Descripción

age more than 18 years

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status < 2
Descripción

ecog performance status < 2

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with deacetylase inhibitor
Descripción

prior treatment with deacetylase inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512474
UMLS CUI [1,2]
C1514463
concurrent therapy with any other investigational agent
Descripción

concurrent therapy with any other investigational agent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1875319
UMLS CUI [1,2]
C0009429
patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study.
Descripción

patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C2986497
clinical symptoms suggesting cns leukemia
Descripción

clinical symptoms suggesting cns leukemia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1332884
UMLS CUI [1,2]
C1457887
lvef below 45% other protocol-defined inclusion/exclusion criteria may apply
Descripción

lvef below 45% other protocol-defined inclusion/exclusion criteria may apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428772
Volver a la parte superior de la página

Similar models

Eligibility Acute Myeloid Leukemia NCT01055483

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
AML cytopathologically confirmed, except APL
Item
patients with cytopathologically confirmed diagnosis of aml according to who criteria, excluding acute promyelocytic leukemia.
boolean
C0023467 (UMLS CUI [1,1])
C0456521 (UMLS CUI [1,2])
C0023487 (UMLS CUI [2])
first relapsed AML
Item
first relapsed aml
boolean
C0023467 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
refractory aml
Item
primary refractory aml defined as failure to respond to initial induction chemotherapy (no cr) or recurrence within 6 months of initial cr.
boolean
C0023467 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
age
Item
age more than 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG
Item
ecog performance status < 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
deacetylase inhibitor
Item
prior treatment with deacetylase inhibitor
boolean
C1512474 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
investigational agent
Item
concurrent therapy with any other investigational agent
boolean
C1875319 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
doxorubicin cumulative dose
Item
patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study.
boolean
C0013089 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
cns leukemia
Item
clinical symptoms suggesting cns leukemia
boolean
C1332884 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
LVEF
Item
lvef below 45% other protocol-defined inclusion/exclusion criteria may apply
boolean
C0428772 (UMLS CUI [1])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial