Informationen:
Fehler:
ID
13144
Beschreibung
Homoharringtonine Compared With Hydroxyurea for Chronic Myelogenous Leukemia That Has Not Responded to Interferon Alfa; ODM derived from: https://clinicaltrials.gov/show/NCT00004933
Link
https://clinicaltrials.gov/show/NCT00004933
Stichworte
Versionen (1)
- 19.01.16 19.01.16 -
Hochgeladen am
19. Januar 2016
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Leukemia NCT00004933
Eligibility Leukemia NCT00004933
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Leukemia NCT00004933
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
chronic myelogenous leukemia
Item
1.1 diagnosis of chronic myelogenous leukemia (cml) in chronic phase. patients in either accelerated or blastic phases are not eligible. clonal cytogenetic evolution alone does not exclude patients. see appendix i for definitions of accelerated and blastic phases of cml.
boolean
C0023473 (UMLS CUI [1])
philadelphia chromosome
Item
1.2 patients in whom a philadelphia chromosome [t(9;22)] is not detectable by cytogenetic studies are eligible if they meet one of the following criteria:
boolean
C0031526 (UMLS CUI [1])
bcr/abl
Item
bcr/abl protein detectable by immunoblotting
boolean
C0004891 (UMLS CUI [1])
southern blot
Item
bcr/abl rearrangement detectable by southern blot analysis
boolean
C0005862 (UMLS CUI [1])
pcr
Item
polymerase chain reaction (pcr) positive fusion transcripts for bcr/abl
boolean
C0032520 (UMLS CUI [1])
fish
Item
bcr/abl translocation present by fluorescence in situ hybridization (fish).
boolean
C0162789 (UMLS CUI [1])
treatment
Item
2. prior treatment:
boolean
C0087111 (UMLS CUI [1])
homoharringtonine
Item
2.1 no previous therapy with homoharringtonine (hht)
boolean
C0062941 (UMLS CUI [1])
hydroxyurea
Item
2.2 no more than six months cumulative (<180 days) of prior hydroxyurea (hu) therapy. however, patients may not have received more than 60 days of hu treatment after failing interferon. patients with previous intolerance or failure to respond to hu are not eligible.
boolean
C0020402 (UMLS CUI [1])
alpha-interferon
Item
2.3 patients must have failed an adequate trial (5m units/m2/day) of alpha-interferon (ifn) or ifn/ara-c to be eligible, as defined below (any one of the following):
boolean
C0002199 (UMLS CUI [1])
ifn
Item
failure to achieve a complete hematologic response after 6 months of ifn therapy.
boolean
C0002199 (UMLS CUI [1])
ifn
Item
failure to achieve any cytogenetic response (i.e., still 100% ph+) after 12 months of ifn therapy.
boolean
C0002199 (UMLS CUI [1])
adverse effects
Item
intolerable adverse effects of ifn therapy after at least one month of ifn treatment. significant documented toxicity of ≥ grade 3 (using nci common toxicity criteria guidelines) due to ifn is required.
boolean
C0879626 (UMLS CUI [1])
remission, response
Item
loss of a prior hematologic remission or cytogenetic response to ifn.
boolean
C0544452 (UMLS CUI [1])
C1704632 (UMLS CUI [2])
C1704632 (UMLS CUI [2])
wbc
Item
a two-fold increase in wbc count when compared to wbc count when ifn therapy was initiated.
boolean
C0023508 (UMLS CUI [1])
age
Item
3. age ≥ 16 years
boolean
C0001779 (UMLS CUI [1])
tachyarrhythmias
Item
4. patients with uncontrolled tachyarrhythmias (such as, atrial fibrillation, paroxysmal supraventricular tachycardia, and ventricular tachycardias not adequately controlled) are not eligible.
boolean
C0080203 (UMLS CUI [1])
pregnancy, lactation, contraception
Item
5. non-pregnant and non-nursing. treatment under this protocol would expose an unborn child to significant risks. women and men of reproductive potential should agree to use an effective means of birth control.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])