ID

30307

Description

Genetically Modified Haploidentical Natural Killer Cell Infusions for B-Lineage Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00995137

Link

https://clinicaltrials.gov/show/NCT00995137

Keywords

Versions (1)
  1. 5/28/18 5/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 28, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoblastic Leukemia, Acute NCT00995137

English

Eligibility Lymphoblastic Leukemia, Acute NCT00995137

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: less than or equal to 18 years of age. may be greater than 18 years of age if currently a st. jude patient.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with relapsed or refractory b-lineage all who are not eligible for hematopoietic stem cell transplantation (hsct) because their leukemia is not in remission (>5% blasts in bone marrow as evidenced either by morphology or by flow cytometry).
Description

Acute lymphocytic leukemia Recurrent | Acute lymphocytic leukemia refractory | Ineligibility Hemopoietic stem cell transplant | Absence Leukemia Remission | Blasts Bone marrow Percentage Morphology | Blasts Bone marrow Percentage Flow Cytometry

Data type

boolean

Alias
UMLS CUI [1,1]
C0023449
UMLS CUI [1,2]
C0277556
UMLS CUI [2,1]
C0023449
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C1512714
UMLS CUI [3,2]
C0472699
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0023418
UMLS CUI [4,3]
C0544452
UMLS CUI [5,1]
C1982687
UMLS CUI [5,2]
C0439165
UMLS CUI [5,3]
C0332437
UMLS CUI [6,1]
C1982687
UMLS CUI [6,2]
C0439165
UMLS CUI [6,3]
C0016263
shortening fraction greater than or equal to 25%.
Description

Shortening Fraction

Data type

boolean

Alias
UMLS CUI [1]
C1335957
glomerular filtration rate greater than or equal to 50 cc/min/1.73 m2.
Description

Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C0017654
pulse oximetry greater than or equal to 92% on room air.
Description

Oximetry, Pulse

Data type

boolean

Alias
UMLS CUI [1]
C0034108
direct bilirubin less than or equal to 3.0 mg/dl.
Description

Bilirubin, direct measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201916
alanine aminotransferase (alt) is no more than 2 times the upper limit of normal.
Description

Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
aspartate transaminases (ast) is no more than 2 times the upper limit of normal.
Description

Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
karnofsky or lansky performance score of greater than or equal to 50.
Description

Karnofsky Performance Status | Lansky Play-Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1522275
no known allergy to murine products or hama testing results within normal limits.
Description

Absence Hypersensitivity Product Murine | HAMA test Normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C1254351
UMLS CUI [1,4]
C0026809
UMLS CUI [2,1]
C1868744
UMLS CUI [2,2]
C0205307
no prior receipt of a gene-transfer agent (e.g. retroviral, adenoviral, lentiviral vector).
Description

Gene Transfer Agent Absent | Retroviral vector Absent | Adenoviral Vector Absent | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C1880946
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1514926
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1510800
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C3846158
does not have a current pleural or pericardial effusion.
Description

Pleural effusion Absent | Pericardial effusion Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0031039
UMLS CUI [2,2]
C0332197
has a suitable adult family member donor available for nk cell donation.
Description

Donor Family member Adult Available | Donor Suitable Natural Killer Cells Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0086282
UMLS CUI [1,3]
C0001675
UMLS CUI [1,4]
C0470187
UMLS CUI [2,1]
C0013018
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C0022688
UMLS CUI [2,4]
C0040732
has recovered from all acute nci common toxicity criteria grade ii-iv non-hematologic acute toxicities resulting from previous therapy as per the judgment of the principal investigator.
Description

Toxicity CTCAE Grades | Etiology Prior Therapy | Patient recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1514463
UMLS CUI [3]
C1115804
at least two weeks since receipt of any biological therapy, systemic chemotherapy, and/or radiation therapy.
Description

Biological treatment | Systemic Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1531518
UMLS CUI [2]
C1883256
UMLS CUI [3]
C1522449
is not receiving more than the equivalent of prednisone 10 mg daily.
Description

Prednisone Equivalent U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C0205163
UMLS CUI [1,3]
C0456683
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment)
Description

Pregnancy | Serum pregnancy test negative Required | Urine pregnancy test negative Required

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0430061
UMLS CUI [2,2]
C1514873
UMLS CUI [3,1]
C0430057
UMLS CUI [3,2]
C1514873
breastfeeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Lymphoblastic Leukemia, Acute NCT00995137

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age: less than or equal to 18 years of age. may be greater than 18 years of age if currently a st. jude patient.
boolean
C0001779 (UMLS CUI [1])
Acute lymphocytic leukemia Recurrent | Acute lymphocytic leukemia refractory | Ineligibility Hemopoietic stem cell transplant | Absence Leukemia Remission | Blasts Bone marrow Percentage Morphology | Blasts Bone marrow Percentage Flow Cytometry
Item
patients with relapsed or refractory b-lineage all who are not eligible for hematopoietic stem cell transplantation (hsct) because their leukemia is not in remission (>5% blasts in bone marrow as evidenced either by morphology or by flow cytometry).
boolean
C0023449 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C0023449 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C1512714 (UMLS CUI [3,1])
C0472699 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C0023418 (UMLS CUI [4,2])
C0544452 (UMLS CUI [4,3])
C1982687 (UMLS CUI [5,1])
C0439165 (UMLS CUI [5,2])
C0332437 (UMLS CUI [5,3])
C1982687 (UMLS CUI [6,1])
C0439165 (UMLS CUI [6,2])
C0016263 (UMLS CUI [6,3])
Shortening Fraction
Item
shortening fraction greater than or equal to 25%.
boolean
C1335957 (UMLS CUI [1])
Glomerular Filtration Rate
Item
glomerular filtration rate greater than or equal to 50 cc/min/1.73 m2.
boolean
C0017654 (UMLS CUI [1])
Oximetry, Pulse
Item
pulse oximetry greater than or equal to 92% on room air.
boolean
C0034108 (UMLS CUI [1])
Bilirubin, direct measurement
Item
direct bilirubin less than or equal to 3.0 mg/dl.
boolean
C0201916 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alanine aminotransferase (alt) is no more than 2 times the upper limit of normal.
boolean
C0201836 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
aspartate transaminases (ast) is no more than 2 times the upper limit of normal.
boolean
C0201899 (UMLS CUI [1])
Karnofsky Performance Status | Lansky Play-Performance Status
Item
karnofsky or lansky performance score of greater than or equal to 50.
boolean
C0206065 (UMLS CUI [1])
C1522275 (UMLS CUI [2])
Absence Hypersensitivity Product Murine | HAMA test Normal
Item
no known allergy to murine products or hama testing results within normal limits.
boolean
C0332197 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C1254351 (UMLS CUI [1,3])
C0026809 (UMLS CUI [1,4])
C1868744 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Gene Transfer Agent Absent | Retroviral vector Absent | Adenoviral Vector Absent | Other Coding
Item
no prior receipt of a gene-transfer agent (e.g. retroviral, adenoviral, lentiviral vector).
boolean
C1880946 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1514926 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1510800 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3846158 (UMLS CUI [4])
Pleural effusion Absent | Pericardial effusion Absent
Item
does not have a current pleural or pericardial effusion.
boolean
C0032227 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0031039 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Donor Family member Adult Available | Donor Suitable Natural Killer Cells Transplantation
Item
has a suitable adult family member donor available for nk cell donation.
boolean
C0013018 (UMLS CUI [1,1])
C0086282 (UMLS CUI [1,2])
C0001675 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,4])
C0013018 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0022688 (UMLS CUI [2,3])
C0040732 (UMLS CUI [2,4])
Toxicity CTCAE Grades | Etiology Prior Therapy | Patient recovered
Item
has recovered from all acute nci common toxicity criteria grade ii-iv non-hematologic acute toxicities resulting from previous therapy as per the judgment of the principal investigator.
boolean
C0600688 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C1115804 (UMLS CUI [3])
Biological treatment | Systemic Chemotherapy | Therapeutic radiology procedure
Item
at least two weeks since receipt of any biological therapy, systemic chemotherapy, and/or radiation therapy.
boolean
C1531518 (UMLS CUI [1])
C1883256 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Prednisone Equivalent U/day
Item
is not receiving more than the equivalent of prednisone 10 mg daily.
boolean
C0032952 (UMLS CUI [1,1])
C0205163 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Serum pregnancy test negative Required | Urine pregnancy test negative Required
Item
pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment)
boolean
C0032961 (UMLS CUI [1])
C0430061 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0430057 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Breast Feeding
Item
breastfeeding
boolean
C0006147 (UMLS CUI [1])
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