ID

42827

Beschreibung

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

Stichworte

  1. 17.12.15 17.12.15 -
  2. 17.09.21 17.09.21 -
Hochgeladen am

17. September 2021

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Acute Lymphoblastic Leukemia NCT02186860

Eligibility Acute Lymphoblastic Leukemia NCT02186860

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 18-65 years
Beschreibung

age

Datentyp

boolean

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

cd19 positive b cell malignancies

Datentyp

boolean

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

recurrent disease

Datentyp

boolean

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

no available curative treatment options

Datentyp

boolean

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

stage iii-iv disease

Datentyp

boolean

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

creatinine

Datentyp

boolean

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

aspartate transaminase-alanine transaminase ratio

Datentyp

boolean

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

bilirubin

Datentyp

boolean

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

karnofsky performance status

Datentyp

boolean

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

life expectancy

Datentyp

boolean

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

venous access

Datentyp

boolean

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

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women
Beschreibung

pregnant or breastfeeding

Datentyp

boolean

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

immunosuppressive therapy

Datentyp

boolean

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

cns leukemia

Datentyp

boolean

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

malignancies

Datentyp

boolean

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

patients with a history of a seizure disorder or cardiac disorder

Datentyp

boolean

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

immunotherapy

Datentyp

boolean

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

patients with human immunodeficiency virus, hepatitis b or c infection

Datentyp

boolean

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

infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450

Ähnliche Modelle

Eligibility Acute Lymphoblastic Leukemia NCT02186860

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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