ID

17908

Description

Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00509600

Link

https://clinicaltrials.gov/show/NCT00509600

Keywords

Versions (1)
  1. 10/7/16 10/7/16 -
Uploaded on

October 7, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00509600

English

Eligibility Leukemia NCT00509600

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00509600
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. all children greater than 6 months of age and less than 18 years of age with newly-diagnosed previously untreated or previously diagnosed jmml, which has reoccurred after treatment with chemotherapy, stem cell transplantation, and/or cis-retinoic acid.
Description

Child | Age | Juvenile Myelomonocytic Leukemia | Chemotherapy | Stem cell transplant | Isotretinoin | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0349639
UMLS CUI [4]
C0392920
UMLS CUI [5]
C1504389
UMLS CUI [6]
C0022265
UMLS CUI [7]
C0277556
2. a diagnosis of jmml is confirmed only if the following criteria for jmml are met: a) all of the following: absence of t(9;22) or bcr-abl by pcr or fish; absolute monocyte count >1000 (1 x 109/µl); <20% bone marrow blasts; b) at least 2 of the following: elevated hb f hemoglobin; myeloid precursors in peripheral blood; wbc >10,000 (10 x 109/µl); gm-csf hypersensitivity in methylcellulose culture of bone marrow progenitors cells.
Description

Juvenile Myelomonocytic Leukemia | t(9;22) Absence | BCR-ABL Fusion Gene Absence | Polymerase Chain Reaction | Fluorescent in Situ Hybridization | Absolute monocyte count increased | Blasts Bone marrow Percentage | Fetal Hemoglobin Elevated | leukocyte morphology myeloid precursors peripheral blood | White Blood Cell Count procedure | Hypersensitivity Granulocyte-Macrophage Colony-Stimulating Factor | Methylcellulose | Bone Marrow Stem cells

Data type

boolean

Alias
UMLS CUI [1]
C0349639
UMLS CUI [2,1]
C3897138
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1835417
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0032520
UMLS CUI [5]
C0162789
UMLS CUI [6]
C1698571
UMLS CUI [7,1]
C1982687
UMLS CUI [7,2]
C0439165
UMLS CUI [8,1]
C0015936
UMLS CUI [8,2]
C3163633
UMLS CUI [9,1]
C2168792
UMLS CUI [9,2]
C0229664
UMLS CUI [10]
C0023508
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C0079460
UMLS CUI [12]
C0025729
UMLS CUI [13,1]
C0005953
UMLS CUI [13,2]
C0038250
3. adequate hepatic function (bilirubin equal or less than 2.0 mg/dl; alt equal or less than 3x normal)
Description

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
4. adequate renal function (serum creatinine equal or less than 2 x normal)
Description

Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
5. performance status: have a karnofsky score >50.
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
6. written, informed consent according to institution guidelines.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. receiving any other chemotherapy. patients must have been off chemotherapy for at least 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment.
Description

Chemotherapy Discontinued | Toxic effect Due to Prior Therapy | Patient Recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1514463
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0521108
3. febrile neutropenia at study entry.
Description

Febrile Neutropenia

Data type

boolean

Alias
UMLS CUI [1]
C0746883
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Similar models

Eligibility Leukemia NCT00509600

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00509600
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Child | Age | Juvenile Myelomonocytic Leukemia | Chemotherapy | Stem cell transplant | Isotretinoin | Recurrent disease
Item
1. all children greater than 6 months of age and less than 18 years of age with newly-diagnosed previously untreated or previously diagnosed jmml, which has reoccurred after treatment with chemotherapy, stem cell transplantation, and/or cis-retinoic acid.
boolean
C0008059 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0349639 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C1504389 (UMLS CUI [5])
C0022265 (UMLS CUI [6])
C0277556 (UMLS CUI [7])
Juvenile Myelomonocytic Leukemia | t(9;22) Absence | BCR-ABL Fusion Gene Absence | Polymerase Chain Reaction | Fluorescent in Situ Hybridization | Absolute monocyte count increased | Blasts Bone marrow Percentage | Fetal Hemoglobin Elevated | leukocyte morphology myeloid precursors peripheral blood | White Blood Cell Count procedure | Hypersensitivity Granulocyte-Macrophage Colony-Stimulating Factor | Methylcellulose | Bone Marrow Stem cells
Item
2. a diagnosis of jmml is confirmed only if the following criteria for jmml are met: a) all of the following: absence of t(9;22) or bcr-abl by pcr or fish; absolute monocyte count >1000 (1 x 109/µl); <20% bone marrow blasts; b) at least 2 of the following: elevated hb f hemoglobin; myeloid precursors in peripheral blood; wbc >10,000 (10 x 109/µl); gm-csf hypersensitivity in methylcellulose culture of bone marrow progenitors cells.
boolean
C0349639 (UMLS CUI [1])
C3897138 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1835417 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0032520 (UMLS CUI [4])
C0162789 (UMLS CUI [5])
C1698571 (UMLS CUI [6])
C1982687 (UMLS CUI [7,1])
C0439165 (UMLS CUI [7,2])
C0015936 (UMLS CUI [8,1])
C3163633 (UMLS CUI [8,2])
C2168792 (UMLS CUI [9,1])
C0229664 (UMLS CUI [9,2])
C0023508 (UMLS CUI [10])
C0020517 (UMLS CUI [11,1])
C0079460 (UMLS CUI [11,2])
C0025729 (UMLS CUI [12])
C0005953 (UMLS CUI [13,1])
C0038250 (UMLS CUI [13,2])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement
Item
3. adequate hepatic function (bilirubin equal or less than 2.0 mg/dl; alt equal or less than 3x normal)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Renal function | Creatinine measurement, serum
Item
4. adequate renal function (serum creatinine equal or less than 2 x normal)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Karnofsky Performance Status
Item
5. performance status: have a karnofsky score >50.
boolean
C0206065 (UMLS CUI [1])
Informed Consent
Item
6. written, informed consent according to institution guidelines.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy Discontinued | Toxic effect Due to Prior Therapy | Patient Recovered
Item
2. receiving any other chemotherapy. patients must have been off chemotherapy for at least 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment.
boolean
C0392920 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C0521108 (UMLS CUI [3,2])
Febrile Neutropenia
Item
3. febrile neutropenia at study entry.
boolean
C0746883 (UMLS CUI [1])
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