ID

16714

Description

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

Link

https://clinicaltrials.gov/show/NCT00390897

Keywords

Versions (1)
  1. 8/2/16 8/2/16 -
Uploaded on

August 2, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Myeloid Leukaemia NCT00390897

English

Eligibility Chronic Myeloid Leukaemia NCT00390897

1 forms  
Inclusion Criteria
Description

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).
Description

Philadelphia chromosome positive chronic myelogenous leukemia Chronic phase

Data type

boolean

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

Age

Data type

boolean

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

ECOG performance status

Data type

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).
Description

Informed Consent | Biospecimen Consent

Data type

boolean

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

Exclusion Criteria

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

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

Data type

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.
Description

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

Data type

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).
Description

Therapeutic procedure | hydroxyurea

Data type

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).
Description

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

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]
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).
Description

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

Data type

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.
Description

HIV Seropositivity

Data type

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).
Description

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

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

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

Eligibility Chronic Myeloid Leukaemia NCT00390897

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
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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