ID

12650

Descrição

Multi-virus CTLs Expressing CD19 Chimeric Receptors, CD19 Positive Malignancies Post SCT, MULTIPRAT; ODM derived from: https://clinicaltrials.gov/show/NCT00840853

Link

https://clinicaltrials.gov/show/NCT00840853

Palavras-chave

Versões (1)
  1. 07/12/2015 07/12/2015 -
Transferido a

7 de dezembro de 2015

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia (ALL) NCT00840853

Inglês

Eligibility Acute Lymphoblastic Leukemia (ALL) NCT00840853

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
any patient regardless of sex or age with cd19+ b-all undergoing allogeneic hsct (group a)
Descrição

any patient regardless of sex or age with cd19+ b-all undergoing allogeneic hsct (group a)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2698589
UMLS CUI [2]
C0006413
UMLS CUI [3]
C1705576
or any patient regardless of sex or age with cd19+ b-cll or nhl undergoing allogeneic hsct (group b).
Descrição

or any patient regardless of sex or age with cd19+ b-cll or nhl undergoing allogeneic hsct (group b)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2698589
UMLS CUI [2]
C0023434
UMLS CUI [3]
C0024305
UMLS CUI [4]
C1705576
with minimal residual disease (mrd) or relapse post-hsct (for the phase i dose escalation)
Descrição

with minimal residual disease (mrd) or relapse post-hsct (for the phase i dose escalation)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0543478
UMLS CUI [2]
C0277556
with no evidence of all or cll/nhl post-hsct (to be included in the expansion cohort
Descrição

with no evidence of all or cll/nhl post-hsct (to be included in the expansion cohort

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0153876
UMLS CUI [2]
C1705576
patients with life expectancy greater than or equal to 6 weeks
Descrição

life expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
patients with a karnofsky/lansky score greater than or equal to 50
Descrição

karnofsky/lansky score

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206065
donor hiv negative
Descrição

donor hiv negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0481430
5. patient or parent/guardian capable of providing informed consent
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
patients with bilirubin 2x normal or less, ast 3x normal or less, creatinine less than or equal to 2x normal for age and hgb greater than 8.0
Descrição

patients with bilirubin 2x normal or less, ast 3x normal or less, creatinine less than or equal to 2x normal for age and hgb greater than 8.0

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0428321
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0019046
pulse oximetry of greater than 90 percent on room air
Descrição

pulse oximetry

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0034108
sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the ctl infusion. the male partner should use a condom.
Descrição

sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the ctl infusion. the male partner should use a condom.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700589
available allogeneic cd19car transduced tri-virus-specific cytotoxic t lymphocytes with greater than or equal to 15 percent expression of cd19car determined by flow-cytometry and greater than 10 percent killing of one or more viral antigen pulsed targets in a cytotoxicity assay at an effector:target ratio of 20:1.*
Descrição

available allogeneic cd19car transduced tri-virus-specific cytotoxic t lymphocytes with greater than or equal to 15 percent expression of cd19car determined by flow-cytometry and greater than 10 percent killing of one or more viral antigen pulsed targets in a cytotoxicity assay at an effector:target ratio of 20:1.*

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2981182
UMLS CUI [2]
C0201622
patients should have been off other investigational antiviral or antitumor therapy for one month prior to entry in this study.
Descrição

study subject participation status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
note: cell dose is based on total cell numbers and not individual antivirus or antileukemic cell numbers.
Descrição

note: cell dose is based on total cell numbers and not individual antivirus or antileukemic cell numbers

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005771
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe intercurrent infection
Descrição

infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
evidence of graft versus host disease >grade ii
Descrição

graft versus host disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018133
pregnant or lactating
Descrição

pregnant or lactating

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
history of hypersensitivity reactions to murine protein-containing products.
Descrição

history of hypersensitivity reactions to murine protein-containing products.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C1699668
currently taking corticosteroids for therapy of gvhd.
Descrição

corticosteroids gvhd

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149783
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Similar models

Eligibility Acute Lymphoblastic Leukemia (ALL) NCT00840853

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
any patient regardless of sex or age with cd19+ b-all undergoing allogeneic hsct (group a)
Item
any patient regardless of sex or age with cd19+ b-all undergoing allogeneic hsct (group a)
boolean
C2698589 (UMLS CUI [1])
C0006413 (UMLS CUI [2])
C1705576 (UMLS CUI [3])
or any patient regardless of sex or age with cd19+ b-cll or nhl undergoing allogeneic hsct (group b)
Item
or any patient regardless of sex or age with cd19+ b-cll or nhl undergoing allogeneic hsct (group b).
boolean
C2698589 (UMLS CUI [1])
C0023434 (UMLS CUI [2])
C0024305 (UMLS CUI [3])
C1705576 (UMLS CUI [4])
with minimal residual disease (mrd) or relapse post-hsct (for the phase i dose escalation)
Item
with minimal residual disease (mrd) or relapse post-hsct (for the phase i dose escalation)
boolean
C0543478 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
with no evidence of all or cll/nhl post-hsct (to be included in the expansion cohort
Item
with no evidence of all or cll/nhl post-hsct (to be included in the expansion cohort
boolean
C0153876 (UMLS CUI [1])
C1705576 (UMLS CUI [2])
life expectancy
Item
patients with life expectancy greater than or equal to 6 weeks
boolean
C0023671 (UMLS CUI [1])
karnofsky/lansky score
Item
patients with a karnofsky/lansky score greater than or equal to 50
boolean
C0206065 (UMLS CUI [1])
donor hiv negative
Item
donor hiv negative
boolean
C0481430 (UMLS CUI [1])
informed consent
Item
5. patient or parent/guardian capable of providing informed consent
boolean
C0021430 (UMLS CUI [1])
patients with bilirubin 2x normal or less, ast 3x normal or less, creatinine less than or equal to 2x normal for age and hgb greater than 8.0
Item
patients with bilirubin 2x normal or less, ast 3x normal or less, creatinine less than or equal to 2x normal for age and hgb greater than 8.0
boolean
C1278039 (UMLS CUI [1])
C0428321 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
pulse oximetry
Item
pulse oximetry of greater than 90 percent on room air
boolean
C0034108 (UMLS CUI [1])
sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the ctl infusion. the male partner should use a condom.
Item
sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the ctl infusion. the male partner should use a condom.
boolean
C0700589 (UMLS CUI [1])
available allogeneic cd19car transduced tri-virus-specific cytotoxic t lymphocytes with greater than or equal to 15 percent expression of cd19car determined by flow-cytometry and greater than 10 percent killing of one or more viral antigen pulsed targets in a cytotoxicity assay at an effector:target ratio of 20:1.*
Item
available allogeneic cd19car transduced tri-virus-specific cytotoxic t lymphocytes with greater than or equal to 15 percent expression of cd19car determined by flow-cytometry and greater than 10 percent killing of one or more viral antigen pulsed targets in a cytotoxicity assay at an effector:target ratio of 20:1.*
boolean
C2981182 (UMLS CUI [1])
C0201622 (UMLS CUI [2])
study subject participation status
Item
patients should have been off other investigational antiviral or antitumor therapy for one month prior to entry in this study.
boolean
C2348568 (UMLS CUI [1])
note: cell dose is based on total cell numbers and not individual antivirus or antileukemic cell numbers
Item
note: cell dose is based on total cell numbers and not individual antivirus or antileukemic cell numbers.
boolean
C0005771 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
infection
Item
severe intercurrent infection
boolean
C0009450 (UMLS CUI [1])
graft versus host disease
Item
evidence of graft versus host disease >grade ii
boolean
C0018133 (UMLS CUI [1])
pregnant or lactating
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
history of hypersensitivity reactions to murine protein-containing products.
Item
history of hypersensitivity reactions to murine protein-containing products.
boolean
C0020517 (UMLS CUI [1])
C1699668 (UMLS CUI [2])
corticosteroids gvhd
Item
currently taking corticosteroids for therapy of gvhd.
boolean
C0149783 (UMLS CUI [1])
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