ID

21434

Description

Study of Dasatinib in Patients With Chronic Phase Chronic Myeloid Leukemia and a Suboptimal Response to Imatinib; ODM derived from: https://clinicaltrials.gov/show/NCT00320190

Link

https://clinicaltrials.gov/show/NCT00320190

Keywords

Versions (1)
  1. 4/21/17 4/21/17 -
Uploaded on

April 21, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid, Chronic NCT00320190

English

Eligibility Leukemia, Myeloid, Chronic NCT00320190

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic phase ph^+ chronic myeloid leukemia (cml) demonstrating only a suboptimal response, defined as a hematologic response that is less than a complete hematologic response after at least 3 months of monotherapy with imatinib, 400 mg; a cytogenic response (cgr) that is less than a partial cgr (pcgr) after at least 6 months of monotherapy with imatinib, 400 mg; a pcgr after at least 12 months of monotherapy with imatinib, 400 mg; or less than a major molecular response with a complete cgr after at least 18 months of monotherapy with imatinib, 400 mg.
Description

Philadelphia chromosome positive chronic myelogenous leukemia Chronic phase | Response Suboptimal | imatinib Dosage | Hematologic Response Less Than Complete Hematologic Response | Cytogenetic Response Less Than Cytogenetic Partial Response | Cytogenetic Partial Response | Cytogenetic Response Less Than Molecular Major Response | Cytogenetic Complete Response

Data type

boolean

Alias
UMLS CUI [1,1]
C0279543
UMLS CUI [1,2]
C0457343
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C2984009
UMLS CUI [3,1]
C0935989
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C4054793
UMLS CUI [4,2]
C0439092
UMLS CUI [4,3]
C4050175
UMLS CUI [5,1]
C4055168
UMLS CUI [5,2]
C0439092
UMLS CUI [5,3]
C4055169
UMLS CUI [6]
C4055169
UMLS CUI [7,1]
C4055168
UMLS CUI [7,2]
C0439092
UMLS CUI [7,3]
C4049637
UMLS CUI [8]
C4050364
either gender
Description

Gender Both

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C1706086
age of 18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous diagnosis of accelerated phase or blast crisis cml
Description

Accelerated phase chronic myologenic leukemia | Leukemia, blastic crisis (CML)

Data type

boolean

Alias
UMLS CUI [1]
C0919870
UMLS CUI [2]
C0687162
uncontrolled or significant cardiovascular disease
Description

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0750502
history of significant bleeding disorder unrelated to cml
Description

Blood Coagulation Disorder | CML Relationship Absent

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2,1]
C0023473
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0332197
concurrent malignancies
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
intolerance of imatinib, 400 mg
Description

intolerance to imatinib Dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0935989
UMLS CUI [1,3]
C0178602
prior treatment with imatinib at a dose higher than 400 mg
Description

imatinib Dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C0935989
UMLS CUI [1,2]
C0178602
prior stem cell transplantation and/or high-dose chemotherapy for cml
Description

Stem cell transplant CML | HIGH DOSE CHEMOTHEARPY CML

Data type

boolean

Alias
UMLS CUI [1,1]
C1504389
UMLS CUI [1,2]
C0023473
UMLS CUI [2,1]
C0149710
UMLS CUI [2,2]
C0023473
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Similar models

Eligibility Leukemia, Myeloid, Chronic NCT00320190

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Philadelphia chromosome positive chronic myelogenous leukemia Chronic phase | Response Suboptimal | imatinib Dosage | Hematologic Response Less Than Complete Hematologic Response | Cytogenetic Response Less Than Cytogenetic Partial Response | Cytogenetic Partial Response | Cytogenetic Response Less Than Molecular Major Response | Cytogenetic Complete Response
Item
chronic phase ph^+ chronic myeloid leukemia (cml) demonstrating only a suboptimal response, defined as a hematologic response that is less than a complete hematologic response after at least 3 months of monotherapy with imatinib, 400 mg; a cytogenic response (cgr) that is less than a partial cgr (pcgr) after at least 6 months of monotherapy with imatinib, 400 mg; a pcgr after at least 12 months of monotherapy with imatinib, 400 mg; or less than a major molecular response with a complete cgr after at least 18 months of monotherapy with imatinib, 400 mg.
boolean
C0279543 (UMLS CUI [1,1])
C0457343 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C2984009 (UMLS CUI [2,2])
C0935989 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C4054793 (UMLS CUI [4,1])
C0439092 (UMLS CUI [4,2])
C4050175 (UMLS CUI [4,3])
C4055168 (UMLS CUI [5,1])
C0439092 (UMLS CUI [5,2])
C4055169 (UMLS CUI [5,3])
C4055169 (UMLS CUI [6])
C4055168 (UMLS CUI [7,1])
C0439092 (UMLS CUI [7,2])
C4049637 (UMLS CUI [7,3])
C4050364 (UMLS CUI [8])
Gender Both
Item
either gender
boolean
C0079399 (UMLS CUI [1,1])
C1706086 (UMLS CUI [1,2])
Age
Item
age of 18 years or older
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Accelerated phase chronic myologenic leukemia | Leukemia, blastic crisis (CML)
Item
previous diagnosis of accelerated phase or blast crisis cml
boolean
C0919870 (UMLS CUI [1])
C0687162 (UMLS CUI [2])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Significant
Item
uncontrolled or significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Blood Coagulation Disorder | CML Relationship Absent
Item
history of significant bleeding disorder unrelated to cml
boolean
C0005779 (UMLS CUI [1])
C0023473 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Malignant Neoplasms
Item
concurrent malignancies
boolean
C0006826 (UMLS CUI [1])
intolerance to imatinib Dosage
Item
intolerance of imatinib, 400 mg
boolean
C1744706 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
imatinib Dosage
Item
prior treatment with imatinib at a dose higher than 400 mg
boolean
C0935989 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Stem cell transplant CML | HIGH DOSE CHEMOTHEARPY CML
Item
prior stem cell transplantation and/or high-dose chemotherapy for cml
boolean
C1504389 (UMLS CUI [1,1])
C0023473 (UMLS CUI [1,2])
C0149710 (UMLS CUI [2,1])
C0023473 (UMLS CUI [2,2])
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