ID

16714

Beskrivning

Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec®-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia; ODM derived from: https://clinicaltrials.gov/show/NCT00390897

Länk

https://clinicaltrials.gov/show/NCT00390897

Nyckelord

Versioner (1)
  1. 2016-08-02 2016-08-02 -
Uppladdad den

2 augusti 2016

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Myeloid Leukaemia NCT00390897

Engelsk

Eligibility Chronic Myeloid Leukaemia NCT00390897

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with newly-diagnosed chronic-phase ph-positive chronic myeloid leukaemia (maximum 3 months as of the diagnosis of the disease, with the date of the cytogenetic study regarded as such).
Beskrivning

Philadelphia chromosome positive chronic myelogenous leukemia Chronic phase

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279543
UMLS CUI [1,2]
C0457343
2. age between 18 and 72 years (both included).
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. performance status < 2 on the ecog scale (see annex 3).
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. secure written or oral informed consent in the presence of a witness and consent for biological samples (annexes 5 and 6).
Beskrivning

Informed Consent | Biospecimen Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C2347026
UMLS CUI [2,2]
C1511481
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. criteria of acceleration or blastic crisis (see annex 7).
Beskrivning

criteria Leukemia, Myeloid, Accelerated Phase | criteria Leukemia, blastic crisis (CML)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0023472
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C0687162
2. when there is a compatible family donor in patients aged under 40 years or a non-relative donor in patients aged under 30 years (in whom allogenic transplant is still regarded as first-line treatment), the possibility of performing an allogenic transplant as first therapeutic option should be considered. in any case, as this aspect is still a matter of debate, it is left up to each group to take the relevant decision depending on the institution's policy.
Beskrivning

Living related donor HLA Compatibility | Tissue Donor nonrelative | Age | Homologous Transplantation First line treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3494891
UMLS CUI [1,2]
C2348930
UMLS CUI [2,1]
C0040288
UMLS CUI [2,2]
C3844036
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0040739
UMLS CUI [4,2]
C1708063
3. administration of other treatments before inclusion in the protocol (a maximum of 3 months of monotherapy with hydroxyurea is permitted).
Beskrivning

Therapeutic procedure | hydroxyurea

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C0020402
4. altered hepatic or renal function (sgot, sgpt, total bilirubin and creatinine > 1.5 times the upper limit of normality).
Beskrivning

Liver function altered | Renal function altered | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Bilirubin, total measurement | Creatinine measurement, serum

Datatyp

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]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201913
UMLS CUI [6]
C0201976
5. uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoralis, serious heart failure (functional class iii/iv of the new york heart association classification), neuropsychiatric infection or disease (see annex 15).
Beskrivning

Disease Uncontrolled | Thyroid dysfunction | Diabetes Mellitus | Angina Pectoris | Heart failure Serious | New York Heart Association Classification | Neuropsychiatric syndrome

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0348024
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0002962
UMLS CUI [5,1]
C0018801
UMLS CUI [5,2]
C0205404
UMLS CUI [6]
C1275491
UMLS CUI [7]
C3203509
6. positive serology for hiv.
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
7. record of cancer in the last 5 years (barring basal cell skin carcinoma and cervical carcinoma in situ).
Beskrivning

Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0851140
8. pregnancy or breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Chronic Myeloid Leukaemia NCT00390897

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Philadelphia chromosome positive chronic myelogenous leukemia Chronic phase
Item
1. patients with newly-diagnosed chronic-phase ph-positive chronic myeloid leukaemia (maximum 3 months as of the diagnosis of the disease, with the date of the cytogenetic study regarded as such).
boolean
C0279543 (UMLS CUI [1,1])
C0457343 (UMLS CUI [1,2])
Age
Item
2. age between 18 and 72 years (both included).
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. performance status < 2 on the ecog scale (see annex 3).
boolean
C1520224 (UMLS CUI [1])
Informed Consent | Biospecimen Consent
Item
4. secure written or oral informed consent in the presence of a witness and consent for biological samples (annexes 5 and 6).
boolean
C0021430 (UMLS CUI [1])
C2347026 (UMLS CUI [2,1])
C1511481 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
criteria Leukemia, Myeloid, Accelerated Phase | criteria Leukemia, blastic crisis (CML)
Item
1. criteria of acceleration or blastic crisis (see annex 7).
boolean
C0243161 (UMLS CUI [1,1])
C0023472 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C0687162 (UMLS CUI [2,2])
Living related donor HLA Compatibility | Tissue Donor nonrelative | Age | Homologous Transplantation First line treatment
Item
2. when there is a compatible family donor in patients aged under 40 years or a non-relative donor in patients aged under 30 years (in whom allogenic transplant is still regarded as first-line treatment), the possibility of performing an allogenic transplant as first therapeutic option should be considered. in any case, as this aspect is still a matter of debate, it is left up to each group to take the relevant decision depending on the institution's policy.
boolean
C3494891 (UMLS CUI [1,1])
C2348930 (UMLS CUI [1,2])
C0040288 (UMLS CUI [2,1])
C3844036 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C0040739 (UMLS CUI [4,1])
C1708063 (UMLS CUI [4,2])
Therapeutic procedure | hydroxyurea
Item
3. administration of other treatments before inclusion in the protocol (a maximum of 3 months of monotherapy with hydroxyurea is permitted).
boolean
C0087111 (UMLS CUI [1])
C0020402 (UMLS CUI [2])
Liver function altered | Renal function altered | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Bilirubin, total measurement | Creatinine measurement, serum
Item
4. altered hepatic or renal function (sgot, sgpt, total bilirubin and creatinine > 1.5 times the upper limit of normality).
boolean
C0232741 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201913 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Disease Uncontrolled | Thyroid dysfunction | Diabetes Mellitus | Angina Pectoris | Heart failure Serious | New York Heart Association Classification | Neuropsychiatric syndrome
Item
5. uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoralis, serious heart failure (functional class iii/iv of the new york heart association classification), neuropsychiatric infection or disease (see annex 15).
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0348024 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C0002962 (UMLS CUI [4])
C0018801 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C1275491 (UMLS CUI [6])
C3203509 (UMLS CUI [7])
HIV Seropositivity
Item
6. positive serology for hiv.
boolean
C0019699 (UMLS CUI [1])
Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
7. record of cancer in the last 5 years (barring basal cell skin carcinoma and cervical carcinoma in situ).
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
8. pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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