Information:
Fel:
ID
14029
Beskrivning
Phase 1 Study of SGI-110 in Patients With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02293993
Länk
https://clinicaltrials.gov/show/NCT02293993
Nyckelord
Versioner (1)
- 2016-03-22 2016-03-22 -
Uppladdad den
22 mars 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT02293993
Eligibility Acute Myeloid Leukemia NCT02293993
- StudyEvent: Eligibility
Similar models
Eligibility Acute Myeloid Leukemia NCT02293993
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
AML
Item
Male or female patients with a diagnosis of aml (who classification 2008).
boolean
C0023467 (UMLS CUI [1])
Age, relapsed from chemotherapy
Item
patients, 20 years of age or older, who are unresponsive to standard chemotherapy or have relapsed following standard chemotherapy
boolean
C0001779 (UMLS CUI [1])
Age
Item
patients, 65 years of age or older, who are not eligible for standard intensive chemotherapy
boolean
C0001779 (UMLS CUI [1])
ECOG Performance Status
Item
Patients with ecog performance status (ps) of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
Patients with adequate organ function
boolean
Not pregnant or breast feeding
Item
women of child-bearing potential must not be pregnant or breast feeding (pregnancy test will be performed at screening). women of child bearing potential and all men with female partners of child bearing potential must practice two medically acceptable methods of birth control and must not become pregnant or father a child while receiving treatment with sgi-110 and for 3 months following last dosing.
boolean
C3242212 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
allogeneic hematopoietic stem cell transplantation
Item
Patients who have undergone prior allogeneic hematopoietic stem cell transplantation must have no evidence of active graft-versus host disease (gvhd) and must be off immunosuppressive therapy by ≥2 weeks prior to imp administration.
boolean
C1705576 (UMLS CUI [1])
promyelocytic leukemia
Item
patients with acute promyelocytic leukemia accompanied by t(15;17)(q22;q12) or (pml/rara) karyotype abnormalities (include other variant types of apl)
boolean
C0023487 (UMLS CUI [1])
Cancer
Item
patients with multiple cancers (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for at least 3 years)
boolean
C0006826 (UMLS CUI [1])
Life threatening illness
Item
subjects with life-threatening illnesses other than aml or mds, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at risk.
boolean
C1517874 (UMLS CUI [1])
Cardiac Arrhythmia
Item
patients with poorly controlled arrhythmias, or any class 3 or 4 cardiac disease as defined by the new york heart association functional classification
boolean
C0003811 (UMLS CUI [1])
CNS disorder
Item
patients with symptomatic central nervous system involvement.
boolean
C0007682 (UMLS CUI [1])