ID

14029

Description

Phase 1 Study of SGI-110 in Patients With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02293993

Link

https://clinicaltrials.gov/show/NCT02293993

Keywords

  1. 3/22/16 3/22/16 -
Uploaded on

March 22, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Acute Myeloid Leukemia NCT02293993

Eligibility Acute Myeloid Leukemia NCT02293993

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Male or female patients with a diagnosis of aml (who classification 2008).
Description

AML

Data type

boolean

Alias
UMLS CUI [1]
C0023467
patients, 20 years of age or older, who are unresponsive to standard chemotherapy or have relapsed following standard chemotherapy
Description

Age, relapsed from chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients, 65 years of age or older, who are not eligible for standard intensive chemotherapy
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Patients with ecog performance status (ps) of 0 to 2
Description

ECOG Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Patients with adequate organ function
Description

Organ function

Data type

boolean

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.
Description

Not pregnant or breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C3242212
UMLS CUI [2]
C0700589
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.
Description

allogeneic hematopoietic stem cell transplantation

Data type

boolean

Alias
UMLS CUI [1]
C1705576
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with acute promyelocytic leukemia accompanied by t(15;17)(q22;q12) or (pml/rara) karyotype abnormalities (include other variant types of apl)
Description

promyelocytic leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023487
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)
Description

Cancer

Data type

boolean

Alias
UMLS CUI [1]
C0006826
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.
Description

Life threatening illness

Data type

boolean

Alias
UMLS CUI [1]
C1517874
patients with poorly controlled arrhythmias, or any class 3 or 4 cardiac disease as defined by the new york heart association functional classification
Description

Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0003811
patients with symptomatic central nervous system involvement.
Description

CNS disorder

Data type

boolean

Alias
UMLS CUI [1]
C0007682

Similar models

Eligibility Acute Myeloid Leukemia NCT02293993

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
Item Group
C0680251 (UMLS CUI)
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial