ID

42827

Description

Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02186860

Link

https://clinicaltrials.gov/show/NCT02186860

Keywords

  1. 12/17/15 12/17/15 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Acute Lymphoblastic Leukemia NCT02186860

Eligibility Acute Lymphoblastic Leukemia NCT02186860

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 18-65 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with cluster of differentiation 19 (cd19) positive b cell malignancies as confirmed by flow cytometry
Description

cd19 positive b cell malignancies

Data type

boolean

Alias
UMLS CUI [1]
C2698589
refractory or relapsed b cell-acute lymphoblastic leukemia
Description

recurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C0277556
no available curative treatment options (such as hematopoietic stem cell transplantation)
Description

no available curative treatment options

Data type

boolean

Alias
UMLS CUI [1]
C1276305
UMLS CUI [2]
C0686905
stage iii-iv disease
Description

stage iii-iv disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0280425
UMLS CUI [1,2]
C0280426
creatinine < 2.5 mg/dl
Description

creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
aspartate transaminase-alanine transaminase ratio < 3x normal
Description

aspartate transaminase-alanine transaminase ratio

Data type

boolean

Alias
UMLS CUI [1]
C0364051
bilirubin < 2.0 mg/dl
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
karnofsky performance status >= 60
Description

karnofsky performance status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
expected survival time > 3 months
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
adequate venous access for apheresis
Description

venous access

Data type

boolean

Alias
UMLS CUI [1]
C0750164
ability to understand and provide informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women
Description

pregnant or breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
patients requiring t cell immunosuppressive therapy
Description

immunosuppressive therapy

Data type

boolean

Alias
UMLS CUI [1]
C0521304
active central nervous system leukemia
Description

cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
any concurrent active malignancies
Description

malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
patients with a history of a seizure disorder or cardiac disorder
Description

patients with a history of a seizure disorder or cardiac disorder

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0018799
previous treatment with any immunotherapy products
Description

immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0021083
patients with human immunodeficiency virus, hepatitis b or c infection
Description

patients with human immunodeficiency virus, hepatitis b or c infection

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019699
uncontrolled active infection
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450

Similar models

Eligibility Acute Lymphoblastic Leukemia NCT02186860

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age: 18-65 years
boolean
C0001779 (UMLS CUI [1])
cd19 positive b cell malignancies
Item
patients with cluster of differentiation 19 (cd19) positive b cell malignancies as confirmed by flow cytometry
boolean
C2698589 (UMLS CUI [1])
recurrent disease
Item
refractory or relapsed b cell-acute lymphoblastic leukemia
boolean
C0277556 (UMLS CUI [1])
no available curative treatment options
Item
no available curative treatment options (such as hematopoietic stem cell transplantation)
boolean
C1276305 (UMLS CUI [1])
C0686905 (UMLS CUI [2])
stage iii-iv disease
Item
stage iii-iv disease
boolean
C0280425 (UMLS CUI [1,1])
C0280426 (UMLS CUI [1,2])
creatinine
Item
creatinine < 2.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
aspartate transaminase-alanine transaminase ratio
Item
aspartate transaminase-alanine transaminase ratio < 3x normal
boolean
C0364051 (UMLS CUI [1])
bilirubin
Item
bilirubin < 2.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
karnofsky performance status
Item
karnofsky performance status >= 60
boolean
C0206065 (UMLS CUI [1])
life expectancy
Item
expected survival time > 3 months
boolean
C0023671 (UMLS CUI [1])
venous access
Item
adequate venous access for apheresis
boolean
C0750164 (UMLS CUI [1])
informed consent
Item
ability to understand and provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnant or breastfeeding
Item
pregnant or lactating women
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
immunosuppressive therapy
Item
patients requiring t cell immunosuppressive therapy
boolean
C0521304 (UMLS CUI [1])
cns leukemia
Item
active central nervous system leukemia
boolean
C1332884 (UMLS CUI [1])
malignancies
Item
any concurrent active malignancies
boolean
C0006826 (UMLS CUI [1])
patients with a history of a seizure disorder or cardiac disorder
Item
patients with a history of a seizure disorder or cardiac disorder
boolean
C0014544 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
immunotherapy
Item
previous treatment with any immunotherapy products
boolean
C0021083 (UMLS CUI [1])
patients with human immunodeficiency virus, hepatitis b or c infection
Item
patients with human immunodeficiency virus, hepatitis b or c infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
infection
Item
uncontrolled active infection
boolean
C0009450 (UMLS CUI [1])

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