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

Link

https://clinicaltrials.gov/show/NCT00362466

Keywords

Versions (1)
  1. 5/16/18 5/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 16, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00362466

English

Eligibility Leukemia NCT00362466

1 forms  
  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

Data type

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

Data type

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

Data type

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

Data type

boolean

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

Liver function | Renal function

Data type

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

Data type

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

Data type

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

Data type

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

Data type

boolean

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

Cardiovascular Disease Uncontrolled

Data type

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

Data type

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

Data type

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

Data type

boolean

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

Cancer Other | Exception CML

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0023473
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Similar models

Eligibility Leukemia NCT00362466

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00362466
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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