ID

21413

Beschreibung

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

Stichworte

Versionen (1)
  1. 20.04.17 20.04.17 -
Hochgeladen am

20. April 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Leukemia NCT00511069

Englisch

Eligibility Leukemia NCT00511069

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00511069
Criteria
Beschreibung

Criteria

1. age >/=18 years
Beschreibung

Age

Datentyp

boolean

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

Philadelphia positive

Datentyp

boolean

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

imatinib | Complete Hematologic Response Absent

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

imatinib | Cytogenetic Complete Response Absent

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Informed Consent

Datentyp

boolean

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

Exclusion Criteria | Chronic phase

Datentyp

boolean

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

Age

Datentyp

boolean

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

ECOG performance status | WHO performance status scale

Datentyp

boolean

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

Informed Consent Unable

Datentyp

boolean

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

Pregnancy

Datentyp

boolean

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

Accelerated phase | Blastic Phase

Datentyp

boolean

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

Contraceptive methods Refused

Datentyp

boolean

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

Substance Dependence

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Creatinine measurement, serum

Datentyp

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.
Beschreibung

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

Datentyp

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+
Beschreibung

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

Datentyp

boolean

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

Patients

Datentyp

boolean

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

Age

Datentyp

boolean

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

Philadelphia positive

Datentyp

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)
Beschreibung

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

Datentyp

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)
Beschreibung

ECOG performance status | WHO performance status scale

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

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

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

Datentyp

boolean

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

Patients

Datentyp

boolean

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

Age

Datentyp

boolean

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

ECOG performance status | WHO performance status scale

Datentyp

boolean

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

Informed Consent Unable

Datentyp

boolean

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

Pregnancy

Datentyp

boolean

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

Chronic Phase of Disease

Datentyp

boolean

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

Contraceptive methods Refused

Datentyp

boolean

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

Substance Dependence

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Creatinine measurement, serum

Datentyp

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.
Beschreibung

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

Datentyp

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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Ähnliche Modelle

Eligibility Leukemia NCT00511069

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00511069
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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