0 Ratings
ID

21413

Description

Velcade (Bortezomib - PS341) in the Treatment of Patients Over 18 Years With Ph+ Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00511069

Link

https://clinicaltrials.gov/show/NCT00511069

Keywords

Versions (1)
  1. 4/20/17 4/20/17 -
Uploaded on

April 20, 2017

DOI

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License

Creative Commons BY 4.0
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    Eligibility Leukemia NCT00511069

    English

    Eligibility Leukemia NCT00511069

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT00511069
    Criteria
    Description

    Criteria

    1. age >/=18 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. ph positive
    Description

    Philadelphia positive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0457340
    3. absence of a chr after 3 months on imatinib
    Description

    imatinib | Complete Hematologic Response Absent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0935989
    UMLS CUI [2,1]
    C4050175
    UMLS CUI [2,2]
    C0332197
    4. loss of a previously obtained chr on imatinib alone
    Description

    imatinib | Complete Hematologic Response Obtained Previous | Complete Hematologic Response Lost

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0935989
    UMLS CUI [2,1]
    C4050175
    UMLS CUI [2,2]
    C1301820
    UMLS CUI [2,3]
    C0205156
    UMLS CUI [3,1]
    C4050175
    UMLS CUI [3,2]
    C0745777
    5. absence of a ccgr within 12 months on imatinib alone
    Description

    imatinib | Cytogenetic Complete Response Absent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0935989
    UMLS CUI [2,1]
    C4050364
    UMLS CUI [2,2]
    C0332197
    6. loss of a previously obtained ccgr on imatinib alone
    Description

    imatinib | Cytogenetic Complete Response Obtained Previous | Cytogenetic Complete Response Lost

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0935989
    UMLS CUI [2,1]
    C4050364
    UMLS CUI [2,2]
    C1301820
    UMLS CUI [2,3]
    C0205156
    UMLS CUI [3,1]
    C4050364
    UMLS CUI [3,2]
    C0745777
    7. written informed consent
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    exclusion criteria for chronic phase patients :
    Description

    Exclusion Criteria | Chronic phase

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    UMLS CUI [2]
    C0457343
    1. age <18
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. performance status (ecog/who) > 2 (see appendix 2)
    Description

    ECOG performance status | WHO performance status scale

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    UMLS CUI [2]
    C1298650
    3. inability to provide written informed consent
    Description

    Informed Consent Unable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C1299582
    4. pregnancy
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    5. accelerated or blastic phase
    Description

    Accelerated phase | Blastic Phase

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0457345
    UMLS CUI [2]
    C3899938
    6. formal refusal of any recommendation of a safe contraception
    Description

    Contraceptive methods Refused

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0700589
    UMLS CUI [1,2]
    C1705116
    7. alcohol or drug addiction
    Description

    Substance Dependence

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038580
    8. altered hepatic or renal function as defined by ast/alt or bilirubin > 3 times upper normal limits (unl)
    Description

    Liver function altered | Renal function altered | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0232741
    UMLS CUI [1,2]
    C0392747
    UMLS CUI [2,1]
    C0232804
    UMLS CUI [2,2]
    C0392747
    UMLS CUI [3]
    C0151904
    UMLS CUI [4]
    C0151905
    UMLS CUI [5]
    C0741494
    9. serum creatinine > 265 umol/l or >3.0 mg/dl
    Description

    Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    10. any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.
    Description

    Disease At risk Patient | Condition At risk Patient | Disease Study Subject Participation Status Ineligibility | Condition Study Subject Participation Status Ineligibility

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C1444641
    UMLS CUI [1,3]
    C0030705
    UMLS CUI [2,1]
    C0348080
    UMLS CUI [2,2]
    C1444641
    UMLS CUI [2,3]
    C0030705
    UMLS CUI [3,1]
    C0012634
    UMLS CUI [3,2]
    C2348568
    UMLS CUI [3,3]
    C1512714
    UMLS CUI [4,1]
    C0348080
    UMLS CUI [4,2]
    C2348568
    UMLS CUI [4,3]
    C1512714
    inclusion criteria for accelerated and blastic phase or acute lymphoblastic leukemia ph+
    Description

    Inclusion criteria | Accelerated phase | Blastic Phase | Philadelphia chromosome-positive acute lymphoblastic leukemia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1512693
    UMLS CUI [2]
    C0457345
    UMLS CUI [3]
    C3899938
    UMLS CUI [4]
    C1960397
    patients:
    Description

    Patients

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0030705
    1. age >/=18 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. ph positive
    Description

    Philadelphia positive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0457340
    3. loss of a previous hematological response to imatinib alone, with further progression to abp (see section 14 for definitions)
    Description

    imatinib | Hematologic Response Previous | Hematologic Response Lost | Progression Accelerated phase | Progression Blastic Phase

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0935989
    UMLS CUI [2,1]
    C4054793
    UMLS CUI [2,2]
    C0205156
    UMLS CUI [3,1]
    C4054793
    UMLS CUI [3,2]
    C0745777
    UMLS CUI [4,1]
    C0449258
    UMLS CUI [4,2]
    C0457345
    UMLS CUI [5,1]
    C0449258
    UMLS CUI [5,2]
    C3899938
    4. performance status (ecog/who)
    Description

    ECOG performance status | WHO performance status scale

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    UMLS CUI [2]
    C1298650
    5. written informed consent
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    exclusion criteria for accelerated and blastic phase or acute lymphoblastic leukemia ph+
    Description

    Exclusion Criteria | Accelerated phase | Blastic Phase | Philadelphia chromosome-positive acute lymphoblastic leukemia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    UMLS CUI [2]
    C0457345
    UMLS CUI [3]
    C3899938
    UMLS CUI [4]
    C1960397
    patients:
    Description

    Patients

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0030705
    1. age <18
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. performance status (ecog/who) > 2 (see appendix 2)
    Description

    ECOG performance status | WHO performance status scale

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    UMLS CUI [2]
    C1298650
    3. inability to provide written informed consent
    Description

    Informed Consent Unable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C1299582
    4. pregnancy
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    5. chronic phase disease
    Description

    Chronic Phase of Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1333047
    6. formal refusal of any recommendation of a safe contraception
    Description

    Contraceptive methods Refused

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0700589
    UMLS CUI [1,2]
    C1705116
    7. alcohol or drug addiction
    Description

    Substance Dependence

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038580
    8. altered hepatic or renal function as defined by ast/alt or bilirubin > 3 times upper normal limits (unl)
    Description

    Liver function altered | Renal function altered | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0232741
    UMLS CUI [1,2]
    C0392747
    UMLS CUI [2,1]
    C0232804
    UMLS CUI [2,2]
    C0392747
    UMLS CUI [3]
    C0151904
    UMLS CUI [4]
    C0151905
    UMLS CUI [5]
    C0741494
    9. serum creatinine > 265 umol/l or >3.0 mg/dl
    Description

    Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    10. any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.
    Description

    Disease At risk Patient | Condition At risk Patient | Disease Study Subject Participation Status Ineligibility | Condition Study Subject Participation Status Ineligibility

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C1444641
    UMLS CUI [1,3]
    C0030705
    UMLS CUI [2,1]
    C0348080
    UMLS CUI [2,2]
    C1444641
    UMLS CUI [2,3]
    C0030705
    UMLS CUI [3,1]
    C0012634
    UMLS CUI [3,2]
    C2348568
    UMLS CUI [3,3]
    C1512714
    UMLS CUI [4,1]
    C0348080
    UMLS CUI [4,2]
    C2348568
    UMLS CUI [4,3]
    C1512714
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    Eligibility Leukemia NCT00511069

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT00511069
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Age
    Item
    1. age >/=18 years
    boolean
    C0001779 (UMLS CUI [1])
    Philadelphia positive
    Item
    2. ph positive
    boolean
    C0457340 (UMLS CUI [1])
    imatinib | Complete Hematologic Response Absent
    Item
    3. absence of a chr after 3 months on imatinib
    boolean
    C0935989 (UMLS CUI [1])
    C4050175 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    imatinib | Complete Hematologic Response Obtained Previous | Complete Hematologic Response Lost
    Item
    4. loss of a previously obtained chr on imatinib alone
    boolean
    C0935989 (UMLS CUI [1])
    C4050175 (UMLS CUI [2,1])
    C1301820 (UMLS CUI [2,2])
    C0205156 (UMLS CUI [2,3])
    C4050175 (UMLS CUI [3,1])
    C0745777 (UMLS CUI [3,2])
    imatinib | Cytogenetic Complete Response Absent
    Item
    5. absence of a ccgr within 12 months on imatinib alone
    boolean
    C0935989 (UMLS CUI [1])
    C4050364 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    imatinib | Cytogenetic Complete Response Obtained Previous | Cytogenetic Complete Response Lost
    Item
    6. loss of a previously obtained ccgr on imatinib alone
    boolean
    C0935989 (UMLS CUI [1])
    C4050364 (UMLS CUI [2,1])
    C1301820 (UMLS CUI [2,2])
    C0205156 (UMLS CUI [2,3])
    C4050364 (UMLS CUI [3,1])
    C0745777 (UMLS CUI [3,2])
    Informed Consent
    Item
    7. written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Exclusion Criteria | Chronic phase
    Item
    exclusion criteria for chronic phase patients :
    boolean
    C0680251 (UMLS CUI [1])
    C0457343 (UMLS CUI [2])
    Age
    Item
    1. age <18
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status | WHO performance status scale
    Item
    2. performance status (ecog/who) > 2 (see appendix 2)
    boolean
    C1520224 (UMLS CUI [1])
    C1298650 (UMLS CUI [2])
    Informed Consent Unable
    Item
    3. inability to provide written informed consent
    boolean
    C0021430 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    Pregnancy
    Item
    4. pregnancy
    boolean
    C0032961 (UMLS CUI [1])
    Accelerated phase | Blastic Phase
    Item
    5. accelerated or blastic phase
    boolean
    C0457345 (UMLS CUI [1])
    C3899938 (UMLS CUI [2])
    Contraceptive methods Refused
    Item
    6. formal refusal of any recommendation of a safe contraception
    boolean
    C0700589 (UMLS CUI [1,1])
    C1705116 (UMLS CUI [1,2])
    Substance Dependence
    Item
    7. alcohol or drug addiction
    boolean
    C0038580 (UMLS CUI [1])
    Liver function altered | Renal function altered | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin
    Item
    8. altered hepatic or renal function as defined by ast/alt or bilirubin > 3 times upper normal limits (unl)
    boolean
    C0232741 (UMLS CUI [1,1])
    C0392747 (UMLS CUI [1,2])
    C0232804 (UMLS CUI [2,1])
    C0392747 (UMLS CUI [2,2])
    C0151904 (UMLS CUI [3])
    C0151905 (UMLS CUI [4])
    C0741494 (UMLS CUI [5])
    Creatinine measurement, serum
    Item
    9. serum creatinine > 265 umol/l or >3.0 mg/dl
    boolean
    C0201976 (UMLS CUI [1])
    Disease At risk Patient | Condition At risk Patient | Disease Study Subject Participation Status Ineligibility | Condition Study Subject Participation Status Ineligibility
    Item
    10. any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.
    boolean
    C0012634 (UMLS CUI [1,1])
    C1444641 (UMLS CUI [1,2])
    C0030705 (UMLS CUI [1,3])
    C0348080 (UMLS CUI [2,1])
    C1444641 (UMLS CUI [2,2])
    C0030705 (UMLS CUI [2,3])
    C0012634 (UMLS CUI [3,1])
    C2348568 (UMLS CUI [3,2])
    C1512714 (UMLS CUI [3,3])
    C0348080 (UMLS CUI [4,1])
    C2348568 (UMLS CUI [4,2])
    C1512714 (UMLS CUI [4,3])
    Inclusion criteria | Accelerated phase | Blastic Phase | Philadelphia chromosome-positive acute lymphoblastic leukemia
    Item
    inclusion criteria for accelerated and blastic phase or acute lymphoblastic leukemia ph+
    boolean
    C1512693 (UMLS CUI [1])
    C0457345 (UMLS CUI [2])
    C3899938 (UMLS CUI [3])
    C1960397 (UMLS CUI [4])
    Patients
    Item
    patients:
    boolean
    C0030705 (UMLS CUI [1])
    Age
    Item
    1. age >/=18 years
    boolean
    C0001779 (UMLS CUI [1])
    Philadelphia positive
    Item
    2. ph positive
    boolean
    C0457340 (UMLS CUI [1])
    imatinib | Hematologic Response Previous | Hematologic Response Lost | Progression Accelerated phase | Progression Blastic Phase
    Item
    3. loss of a previous hematological response to imatinib alone, with further progression to abp (see section 14 for definitions)
    boolean
    C0935989 (UMLS CUI [1])
    C4054793 (UMLS CUI [2,1])
    C0205156 (UMLS CUI [2,2])
    C4054793 (UMLS CUI [3,1])
    C0745777 (UMLS CUI [3,2])
    C0449258 (UMLS CUI [4,1])
    C0457345 (UMLS CUI [4,2])
    C0449258 (UMLS CUI [5,1])
    C3899938 (UMLS CUI [5,2])
    ECOG performance status | WHO performance status scale
    Item
    4. performance status (ecog/who)
    boolean
    C1520224 (UMLS CUI [1])
    C1298650 (UMLS CUI [2])
    Informed Consent
    Item
    5. written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Exclusion Criteria | Accelerated phase | Blastic Phase | Philadelphia chromosome-positive acute lymphoblastic leukemia
    Item
    exclusion criteria for accelerated and blastic phase or acute lymphoblastic leukemia ph+
    boolean
    C0680251 (UMLS CUI [1])
    C0457345 (UMLS CUI [2])
    C3899938 (UMLS CUI [3])
    C1960397 (UMLS CUI [4])
    Patients
    Item
    patients:
    boolean
    C0030705 (UMLS CUI [1])
    Age
    Item
    1. age <18
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status | WHO performance status scale
    Item
    2. performance status (ecog/who) > 2 (see appendix 2)
    boolean
    C1520224 (UMLS CUI [1])
    C1298650 (UMLS CUI [2])
    Informed Consent Unable
    Item
    3. inability to provide written informed consent
    boolean
    C0021430 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    Pregnancy
    Item
    4. pregnancy
    boolean
    C0032961 (UMLS CUI [1])
    Chronic Phase of Disease
    Item
    5. chronic phase disease
    boolean
    C1333047 (UMLS CUI [1])
    Contraceptive methods Refused
    Item
    6. formal refusal of any recommendation of a safe contraception
    boolean
    C0700589 (UMLS CUI [1,1])
    C1705116 (UMLS CUI [1,2])
    Substance Dependence
    Item
    7. alcohol or drug addiction
    boolean
    C0038580 (UMLS CUI [1])
    Liver function altered | Renal function altered | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin
    Item
    8. altered hepatic or renal function as defined by ast/alt or bilirubin > 3 times upper normal limits (unl)
    boolean
    C0232741 (UMLS CUI [1,1])
    C0392747 (UMLS CUI [1,2])
    C0232804 (UMLS CUI [2,1])
    C0392747 (UMLS CUI [2,2])
    C0151904 (UMLS CUI [3])
    C0151905 (UMLS CUI [4])
    C0741494 (UMLS CUI [5])
    Creatinine measurement, serum
    Item
    9. serum creatinine > 265 umol/l or >3.0 mg/dl
    boolean
    C0201976 (UMLS CUI [1])
    Disease At risk Patient | Condition At risk Patient | Disease Study Subject Participation Status Ineligibility | Condition Study Subject Participation Status Ineligibility
    Item
    10. any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.
    boolean
    C0012634 (UMLS CUI [1,1])
    C1444641 (UMLS CUI [1,2])
    C0030705 (UMLS CUI [1,3])
    C0348080 (UMLS CUI [2,1])
    C1444641 (UMLS CUI [2,2])
    C0030705 (UMLS CUI [2,3])
    C0012634 (UMLS CUI [3,1])
    C2348568 (UMLS CUI [3,2])
    C1512714 (UMLS CUI [3,3])
    C0348080 (UMLS CUI [4,1])
    C2348568 (UMLS CUI [4,2])
    C1512714 (UMLS CUI [4,3])
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