ID

28076

Description

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

Link

https://clinicaltrials.gov/show/NCT00451035

Keywords

Versions (1)
  1. 12/15/17 12/15/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 15, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Myeloid Leukemia in Chronic Phase NCT00451035

English

Eligibility Chronic Myeloid Leukemia in Chronic Phase NCT00451035

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

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

Chronic-Phase Myeloid Leukemia Philadelphia chromosome positive

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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
Description

Laboratory Results

Data type

boolean

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

Left ventricular ejection fraction

Data type

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
Description

Ability Performance of activities of daily living ECOG performance status

Data type

boolean

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

Exclusion Criteria

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

Hemopoietic stem cell transplant Scheduled

Data type

boolean

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

Prior Therapy Pharmaceutical Preparations Some

Data type

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
Description

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

Data type

boolean

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

Decreased cardiac function | Heart Diseases

Data type

boolean

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

Concomitant Agent Some

Data type

boolean

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

Gastrointestinal function Impaired | Gastrointestinal Diseases

Data type

boolean

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

Diarrhea Resolution Lacking

Data type

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
Description

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

Data type

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
Description

LBH589 | Bcr-Abl Tyrosine Kinase Inhibitors Received Nearby

Data type

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
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Data type

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
Description

Gender | Partner Childbearing Potential | Childbearing Potential Contraceptive methods Lacking

Data type

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
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Chronic Myeloid Leukemia in Chronic Phase NCT00451035

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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