ID

30161

Description

A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00362466

Lien

https://clinicaltrials.gov/show/NCT00362466

Mots-clés

Versions (1)
  1. 16/05/2018 16/05/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

16 mai 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Leukemia NCT00362466

Anglais

Eligibility Leukemia NCT00362466

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00362466
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women ≥18 years diagnosed with chronic phase philadelphia chromosome positive (cp ph+) cml who have failed to achieve ccyr after 3-18 months of therapy with imatinib 400 mg
Description

Age | Philadelphia chromosome positive CML Chronic phase | Cytogenetic Complete Response failed | Imatinib Dosage

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0279543
UMLS CUI [2,2]
C0457343
UMLS CUI [3,1]
C4050364
UMLS CUI [3,2]
C0231175
UMLS CUI [4,1]
C0935989
UMLS CUI [4,2]
C0178602
treatment initiation with imatinib 400 mg within 6 months of initial cml diagnosis
Description

Imatinib Dosage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0935989
UMLS CUI [1,2]
C0178602
able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past
Description

Imatinib High dose chronic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0935989
UMLS CUI [1,2]
C0444956
UMLS CUI [1,3]
C0205191
eastern cooperative oncology group performance status (ecog ps) 0-2
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
adequate hepatic and renal function
Description

Liver function | Renal function

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
eligible and willing to undergo immediate autologous/allogeneic stem cell transplant
Description

Autologous hematopoietic stem cell transplant | Allogeneic hematopoietic stem cell transplant

Type de données

boolean

Alias
UMLS CUI [1]
C2193200
UMLS CUI [2]
C4255274
previous diagnosis of accelerated/blast crisis cml
Description

Leukemia, Myeloid, Accelerated Phase | Chronic myelogenous leukemia with crisis of blast cells

Type de données

boolean

Alias
UMLS CUI [1]
C0023472
UMLS CUI [2]
C2861579
subjects with clonal evolution in ph+ cells observed in ≥2 metaphases
Description

Clonal Evolution Cells Philadelphia chromosome positive | Observation Metaphase Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C1516669
UMLS CUI [1,2]
C0007634
UMLS CUI [1,3]
C0856536
UMLS CUI [2,1]
C1964257
UMLS CUI [2,2]
C1621812
UMLS CUI [2,3]
C1265611
previous documentation of t315i mutation
Description

T315I mutation

Type de données

boolean

Alias
UMLS CUI [1]
C3889036
uncontrolled or significant cardiovascular disease
Description

Cardiovascular Disease Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
serious uncontrolled medical disorder/active infection
Description

Disease Serious Uncontrolled | Communicable Disease Serious Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
history of significant bleeding disorder unrelated to cml
Description

Blood Coagulation Disorder Independent of CML

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0023473
intolerance to imatinib ≥400 mg
Description

Intolerance to imatinib

Type de données

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0935989
concurrent malignancies other than cml
Description

Cancer Other | Exception CML

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0023473
Retour au début de la page

Similar models

Eligibility Leukemia NCT00362466

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00362466
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age | Philadelphia chromosome positive CML Chronic phase | Cytogenetic Complete Response failed | Imatinib Dosage
Item
men and women ≥18 years diagnosed with chronic phase philadelphia chromosome positive (cp ph+) cml who have failed to achieve ccyr after 3-18 months of therapy with imatinib 400 mg
boolean
C0001779 (UMLS CUI [1])
C0279543 (UMLS CUI [2,1])
C0457343 (UMLS CUI [2,2])
C4050364 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0935989 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
Imatinib Dosage
Item
treatment initiation with imatinib 400 mg within 6 months of initial cml diagnosis
boolean
C0935989 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Imatinib High dose chronic
Item
able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past
boolean
C0935989 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group performance status (ecog ps) 0-2
boolean
C1520224 (UMLS CUI [1])
Liver function | Renal function
Item
adequate hepatic and renal function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Autologous hematopoietic stem cell transplant | Allogeneic hematopoietic stem cell transplant
Item
eligible and willing to undergo immediate autologous/allogeneic stem cell transplant
boolean
C2193200 (UMLS CUI [1])
C4255274 (UMLS CUI [2])
Leukemia, Myeloid, Accelerated Phase | Chronic myelogenous leukemia with crisis of blast cells
Item
previous diagnosis of accelerated/blast crisis cml
boolean
C0023472 (UMLS CUI [1])
C2861579 (UMLS CUI [2])
Clonal Evolution Cells Philadelphia chromosome positive | Observation Metaphase Quantity
Item
subjects with clonal evolution in ph+ cells observed in ≥2 metaphases
boolean
C1516669 (UMLS CUI [1,1])
C0007634 (UMLS CUI [1,2])
C0856536 (UMLS CUI [1,3])
C1964257 (UMLS CUI [2,1])
C1621812 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
T315I mutation
Item
previous documentation of t315i mutation
boolean
C3889036 (UMLS CUI [1])
Cardiovascular Disease Uncontrolled
Item
uncontrolled or significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Disease Serious Uncontrolled | Communicable Disease Serious Uncontrolled
Item
serious uncontrolled medical disorder/active infection
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
Blood Coagulation Disorder Independent of CML
Item
history of significant bleeding disorder unrelated to cml
boolean
C0005779 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0023473 (UMLS CUI [1,3])
Intolerance to imatinib
Item
intolerance to imatinib ≥400 mg
boolean
C1744706 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
Cancer Other | Exception CML
Item
concurrent malignancies other than cml
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0023473 (UMLS CUI [2,2])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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