ID

28076

Beskrivning

Efficacy and Safety of LBH589 in Adult Patients With Refractory Chronic Myeloid Leukemia (CML) in Chronic Phase; ODM derived from: https://clinicaltrials.gov/show/NCT00451035

Länk

https://clinicaltrials.gov/show/NCT00451035

Nyckelord

Versioner (1)
  1. 2017-12-15 2017-12-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 december 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Chronic Myeloid Leukemia in Chronic Phase NCT00451035

Engelsk

Eligibility Chronic Myeloid Leukemia in Chronic Phase NCT00451035

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients aged ≥ 18 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of philadelphia chromosome positive, chronic phase chronic myeloid leukemia
Beskrivning

Chronic-Phase Myeloid Leukemia Philadelphia chromosome positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023474
UMLS CUI [1,2]
C0856536
prior treatment with at least two bcr-abl tyrosine kinase inhibitors with demonstrated resistance to the most recent kinase inhibitor therapy.
Beskrivning

Bcr-Abl Tyrosine Kinase Inhibitors Quantity | Protein tyrosine kinase inhibitor therapy Recent Resistance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2267122
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0879484
UMLS CUI [2,2]
C0332185
UMLS CUI [2,3]
C1514892
patients with a history of intolerance to one bcr-abl kinase inhibitors will be considered eligible to enter the study if they demonstrate resistance to their most recent bcr-abl kinase inhibitor.
Beskrivning

Intolerance to Bcr-Abl Tyrosine Kinase Inhibitors Quantity | Bcr-Abl Tyrosine Kinase Inhibitors Recent Resistance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C2267122
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C2267122
UMLS CUI [2,2]
C0332185
UMLS CUI [2,3]
C1514892
patients who are intolerant of at least 2 bcr-abl kinase inhibitors will be considered eligible to enter this study if they also demonstrate resistance to or intolerance of interferon-alpha (ifn-α) by the same criteria defined above.
Beskrivning

Intolerance to Bcr-Abl Tyrosine Kinase Inhibitors Quantity | Interferon-alpha Resistance | Intolerance to Interferon-alpha

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C2267122
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0002199
UMLS CUI [2,2]
C1514892
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0002199
patients must have adequate laboratory values
Beskrivning

Laboratory Results

Datatyp

boolean

Alias
UMLS CUI [1]
C1254595
baseline measurement of left ventricular ejection fraction [assessment of the hearts ability to pump effectively]
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
assessment of patients ability to perform every day activities. assessment by the ecog [eastern cooperative oncology group] performance status
Beskrivning

Ability Performance of activities of daily living ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1821398
UMLS CUI [1,3]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
a candidate for hematopoietic stem cell transplantation
Beskrivning

Hemopoietic stem cell transplant Scheduled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0472699
UMLS CUI [1,2]
C0205539
prior therapy with certain medications
Beskrivning

Prior Therapy Pharmaceutical Preparations Some

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0205392
patients with a prior history of accelerated phase or blast crisis cml
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0023472
UMLS CUI [2]
C2861579
impaired cardiac function or clinically significant cardiac diseases
Beskrivning

Decreased cardiac function | Heart Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0232166
UMLS CUI [2]
C0018799
concomitant use of certain medications
Beskrivning

Concomitant Agent Some

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0205392
impairment of gi function or gi disease
Beskrivning

Gastrointestinal function Impaired | Gastrointestinal Diseases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0516983
UMLS CUI [1,2]
C0221099
UMLS CUI [2]
C0017178
patients with unresolved diarrhea
Beskrivning

Diarrhea Resolution Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C1514893
UMLS CUI [1,3]
C0332268
patients who have received chemotherapy, any investigational drugs or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Beskrivning

Chemotherapy | Investigational New Drugs | Major surgery | Side effects Recovery Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0679637
UMLS CUI [4,1]
C0879626
UMLS CUI [4,2]
C2004454
UMLS CUI [4,3]
C0332268
patients who have received a bcr-abl tyrosine-kinase inhibitor within 1 week of first treatment with lbh589
Beskrivning

LBH589 | Bcr-Abl Tyrosine Kinase Inhibitors Received Nearby

Datatyp

boolean

Alias
UMLS CUI [1]
C1566164
UMLS CUI [2,1]
C2267122
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C1706276
women who are pregnant or breast feeding or women of childbearing potential not using an effective method of birth control
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
male patients whose sexual partners are women of child bearing potential not using effective birth control
Beskrivning

Gender | Partner Childbearing Potential | Childbearing Potential Contraceptive methods Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C3831118
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
other protocol-defined inclusion/exclusion criteria may apply
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Tillbaka till toppen

Similar models

Eligibility Chronic Myeloid Leukemia in Chronic Phase NCT00451035

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients aged ≥ 18 years old
boolean
C0001779 (UMLS CUI [1])
Chronic-Phase Myeloid Leukemia Philadelphia chromosome positive
Item
diagnosis of philadelphia chromosome positive, chronic phase chronic myeloid leukemia
boolean
C0023474 (UMLS CUI [1,1])
C0856536 (UMLS CUI [1,2])
Bcr-Abl Tyrosine Kinase Inhibitors Quantity | Protein tyrosine kinase inhibitor therapy Recent Resistance
Item
prior treatment with at least two bcr-abl tyrosine kinase inhibitors with demonstrated resistance to the most recent kinase inhibitor therapy.
boolean
C2267122 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0879484 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1514892 (UMLS CUI [2,3])
Intolerance to Bcr-Abl Tyrosine Kinase Inhibitors Quantity | Bcr-Abl Tyrosine Kinase Inhibitors Recent Resistance
Item
patients with a history of intolerance to one bcr-abl kinase inhibitors will be considered eligible to enter the study if they demonstrate resistance to their most recent bcr-abl kinase inhibitor.
boolean
C1744706 (UMLS CUI [1,1])
C2267122 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2267122 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1514892 (UMLS CUI [2,3])
Intolerance to Bcr-Abl Tyrosine Kinase Inhibitors Quantity | Interferon-alpha Resistance | Intolerance to Interferon-alpha
Item
patients who are intolerant of at least 2 bcr-abl kinase inhibitors will be considered eligible to enter this study if they also demonstrate resistance to or intolerance of interferon-alpha (ifn-α) by the same criteria defined above.
boolean
C1744706 (UMLS CUI [1,1])
C2267122 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0002199 (UMLS CUI [2,1])
C1514892 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0002199 (UMLS CUI [3,2])
Laboratory Results
Item
patients must have adequate laboratory values
boolean
C1254595 (UMLS CUI [1])
Left ventricular ejection fraction
Item
baseline measurement of left ventricular ejection fraction [assessment of the hearts ability to pump effectively]
boolean
C0428772 (UMLS CUI [1])
Ability Performance of activities of daily living ECOG performance status
Item
assessment of patients ability to perform every day activities. assessment by the ecog [eastern cooperative oncology group] performance status
boolean
C0085732 (UMLS CUI [1,1])
C1821398 (UMLS CUI [1,2])
C1520224 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hemopoietic stem cell transplant Scheduled
Item
a candidate for hematopoietic stem cell transplantation
boolean
C0472699 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Prior Therapy Pharmaceutical Preparations Some
Item
prior therapy with certain medications
boolean
C1514463 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205392 (UMLS CUI [1,3])
Leukemia, Myeloid, Accelerated Phase | Chronic myelogenous leukemia with crisis of blast cells
Item
patients with a prior history of accelerated phase or blast crisis cml
boolean
C0023472 (UMLS CUI [1])
C2861579 (UMLS CUI [2])
Decreased cardiac function | Heart Diseases
Item
impaired cardiac function or clinically significant cardiac diseases
boolean
C0232166 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
Concomitant Agent Some
Item
concomitant use of certain medications
boolean
C2347852 (UMLS CUI [1,1])
C0205392 (UMLS CUI [1,2])
Gastrointestinal function Impaired | Gastrointestinal Diseases
Item
impairment of gi function or gi disease
boolean
C0516983 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2])
Diarrhea Resolution Lacking
Item
patients with unresolved diarrhea
boolean
C0011991 (UMLS CUI [1,1])
C1514893 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Chemotherapy | Investigational New Drugs | Major surgery | Side effects Recovery Lacking
Item
patients who have received chemotherapy, any investigational drugs or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
boolean
C0392920 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0679637 (UMLS CUI [3])
C0879626 (UMLS CUI [4,1])
C2004454 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
LBH589 | Bcr-Abl Tyrosine Kinase Inhibitors Received Nearby
Item
patients who have received a bcr-abl tyrosine-kinase inhibitor within 1 week of first treatment with lbh589
boolean
C1566164 (UMLS CUI [1])
C2267122 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1706276 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
women who are pregnant or breast feeding or women of childbearing potential not using an effective method of birth control
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Gender | Partner Childbearing Potential | Childbearing Potential Contraceptive methods Lacking
Item
male patients whose sexual partners are women of child bearing potential not using effective birth control
boolean
C0079399 (UMLS CUI [1])
C0682323 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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