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])
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])