ID

36268

Beskrivning

Phase I, Dose Escalation Study of Decitabine; ODM derived from: https://clinicaltrials.gov/show/NCT02264873

Länk

https://clinicaltrials.gov/show/NCT02264873

Nyckelord

Versioner (1)
  1. 2019-04-27 2019-04-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 april 2019

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia, Lymphoblastic, Acute NCT02264873

Engelsk

Eligibility Leukemia, Lymphoblastic, Acute NCT02264873

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: greater than 1 and less than 31 years of age;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis: history of all, aml or mds, currently in a complete remission (cr) following allo-hsct (bone marrow leukemic blasts less than 5% by morphology), with high risk features including:
Beskrivning

Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute | MYELODYSPLASTIC SYNDROME | In complete remission Following Allogeneic Hematopoietic Stem Cell Transplantation | Bone Marrow Leukemic Blast Count | Feature High risk

Datatyp

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0023467
UMLS CUI [3]
C3463824
UMLS CUI [4,1]
C0677874
UMLS CUI [4,2]
C0332282
UMLS CUI [4,3]
C1705576
UMLS CUI [5,1]
C0005953
UMLS CUI [5,2]
C2697913
UMLS CUI [6,1]
C2348519
UMLS CUI [6,2]
C4319571
status post allogeneic hsct
Beskrivning

Status post Allogeneic Hematopoietic Stem Cell Transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C1705576
gvhd prophylaxis:
Beskrivning

Prophylaxis against graft versus host disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1096407
karnofsky or lansky performance scores more than 50%. karnofsky scores will be used for patients > 16 years of age and lansky scores for patients ≤ 16 years of age;
Beskrivning

Karnofsky Performance Status | Lansky Play-Performance Status | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1522275
UMLS CUI [3]
C0001779
platelet count ≥ 50,000 (untransfused);
Beskrivning

Platelet Count measurement | Transfusion Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C1879316
UMLS CUI [2,2]
C0332197
absolute neutrophil count ≥ 1000; and;
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin ≥ 8 g/dl (un-transfused);
Beskrivning

Hemoglobin measurement | Transfusion Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2,1]
C1879316
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
progressive disease;
Beskrivning

Progressive Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1335499
philadelphia chromosome positive all (these patients receive tyrosine kinase inhibitor posttransplant);
Beskrivning

Philadelphia positive acute lymphocytic leukaemia | Tyrosine kinase inhibitor therapy Post Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C4524071
UMLS CUI [2,1]
C0879484
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0040732
known hypersensitivity to any components of decitabine;
Beskrivning

Hypersensitivity Decitabine Component

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0049065
UMLS CUI [1,3]
C1705248
uncontrolled grade 3-4 graft versus host disease;
Beskrivning

Graft-vs-Host Disease Grade Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018133
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0205318
uncontrolled infection;
Beskrivning

Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
serum creatinine > 2 mg/dl or glomerular filtration rate (gfr) less than 60 ml/min/1.73m2 ;
Beskrivning

Creatinine measurement, serum | Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0017654
alanine aminotransferase (alt) greater than 3 times normal or serum total bilirubin greater than 2 mg/dl;
Beskrivning

Alanine aminotransferase increased | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C1278039
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Similar models

Eligibility Leukemia, Lymphoblastic, Acute NCT02264873

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age: greater than 1 and less than 31 years of age;
boolean
C0001779 (UMLS CUI [1])
Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute | MYELODYSPLASTIC SYNDROME | In complete remission Following Allogeneic Hematopoietic Stem Cell Transplantation | Bone Marrow Leukemic Blast Count | Feature High risk
Item
diagnosis: history of all, aml or mds, currently in a complete remission (cr) following allo-hsct (bone marrow leukemic blasts less than 5% by morphology), with high risk features including:
boolean
C0023449 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
C3463824 (UMLS CUI [3])
C0677874 (UMLS CUI [4,1])
C0332282 (UMLS CUI [4,2])
C1705576 (UMLS CUI [4,3])
C0005953 (UMLS CUI [5,1])
C2697913 (UMLS CUI [5,2])
C2348519 (UMLS CUI [6,1])
C4319571 (UMLS CUI [6,2])
Status post Allogeneic Hematopoietic Stem Cell Transplantation
Item
status post allogeneic hsct
boolean
C0231290 (UMLS CUI [1,1])
C1705576 (UMLS CUI [1,2])
Prophylaxis against graft versus host disease
Item
gvhd prophylaxis:
boolean
C1096407 (UMLS CUI [1])
Karnofsky Performance Status | Lansky Play-Performance Status | Age
Item
karnofsky or lansky performance scores more than 50%. karnofsky scores will be used for patients > 16 years of age and lansky scores for patients ≤ 16 years of age;
boolean
C0206065 (UMLS CUI [1])
C1522275 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Platelet Count measurement | Transfusion Absent
Item
platelet count ≥ 50,000 (untransfused);
boolean
C0032181 (UMLS CUI [1])
C1879316 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Absolute neutrophil count
Item
absolute neutrophil count ≥ 1000; and;
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement | Transfusion Absent
Item
hemoglobin ≥ 8 g/dl (un-transfused);
boolean
C0518015 (UMLS CUI [1])
C1879316 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Progressive Disease
Item
progressive disease;
boolean
C1335499 (UMLS CUI [1])
Philadelphia positive acute lymphocytic leukaemia | Tyrosine kinase inhibitor therapy Post Transplantation
Item
philadelphia chromosome positive all (these patients receive tyrosine kinase inhibitor posttransplant);
boolean
C4524071 (UMLS CUI [1])
C0879484 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
Hypersensitivity Decitabine Component
Item
known hypersensitivity to any components of decitabine;
boolean
C0020517 (UMLS CUI [1,1])
C0049065 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Graft-vs-Host Disease Grade Uncontrolled
Item
uncontrolled grade 3-4 graft versus host disease;
boolean
C0018133 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Communicable Disease Uncontrolled
Item
uncontrolled infection;
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Creatinine measurement, serum | Glomerular Filtration Rate
Item
serum creatinine > 2 mg/dl or glomerular filtration rate (gfr) less than 60 ml/min/1.73m2 ;
boolean
C0201976 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
Alanine aminotransferase increased | Serum total bilirubin measurement
Item
alanine aminotransferase (alt) greater than 3 times normal or serum total bilirubin greater than 2 mg/dl;
boolean
C0151905 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
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