ID

12788

Description

CASPALLO: Allodepleted T Cells Transduced With Inducible Caspase 9 Suicide Gene; ODM derived from: https://clinicaltrials.gov/show/NCT00710892

Link

https://clinicaltrials.gov/show/NCT00710892

Keywords

Versions (1)
  1. 12/21/15 12/21/15 -
Uploaded on

December 21, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT00710892

English

Eligibility Acute Lymphoblastic Leukemia NCT00710892

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
at the time of transplant:
Description

time of transplant

Data type

boolean

Alias
UMLS CUI [1]
C3262320
patients (up to 65 years of age) with:
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
all or high grade nhl that is stage iii or iv and has relapsed or is considered to be primary refractory disease.
Description

all or high grade nhl

Data type

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0024305
myelodysplastic syndrome.
Description

myelodysplastic syndrome

Data type

boolean

Alias
UMLS CUI [1]
C3463824
aml after first relapse or with primary refractory disease.
Description

aml after first relapse or with primary refractory disease

Data type

boolean

Alias
UMLS CUI [1]
C2367456
UMLS CUI [2]
C1514815
cml
Description

cml

Data type

boolean

Alias
UMLS CUI [1]
C0279899
hemophagocytic lymphohistiocytosis (hlh); familial hemophagocytic lymphohistiocytosis (flh); viral-associated hemophagocytic syndrome (vahs); patients with severe chronic active epstein barr virus infection (scaebv) with predilection for t or nk cell malignancy; x-linked lymphoproliferative disease (xlp)
Description

hemophagocytic lymphohistiocytosis (hlh); familial hemophagocytic lymphohistiocytosis (flh); viral-associated hemophagocytic syndrome (vahs); patients with severe chronic active epstein barr virus infection

Data type

boolean

Alias
UMLS CUI [1]
C0024291
UMLS CUI [2]
C0272199
UMLS CUI [3]
C0019068
UMLS CUI [4]
C0549463
UMLS CUI [5]
C0149678
lack of suitable conventional donor (i.e. 5/6 or 6/6 related, or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor.
Description

lack of suitable conventional donor (i.e. 5/6 or 6/6 related, or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease

Data type

boolean

Alias
UMLS CUI [1]
C0013018
UMLS CUI [2]
C1335499
at the time of allodepleted t cell infusion:
Description

allodepleted t cell infusion

Data type

boolean

Alias
UMLS CUI [1]
C3897408
engrafted with anc greater than 500.
Description

anc

Data type

boolean

Alias
UMLS CUI [1]
C0948762
must have greater than or equal to 50 percent donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease.
Description

must have greater than or equal to 50 percent donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease.

Data type

boolean

Alias
UMLS CUI [1]
C3250865
UMLS CUI [2]
C0277556
life expectancy greater than 30 days
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
lansky/karnofsky scores greater than or equal to 60
Description

karnofsky

Data type

boolean

Alias
UMLS CUI [1]
C0206065
absence of severe renal disease (creatinine greater than 2x normal for age)
Description

renal disease

Data type

boolean

Alias
UMLS CUI [1]
C0022658
absence of severe hepatic disease (direct bilirubin greater than 2 mg/dl, or sgot greater than 200
Description

liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
oxygen saturation greater than 94 percent on room air
Description

spo2

Data type

boolean

Alias
UMLS CUI [1]
C0428179
patient/guardian able to give informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
at the time of transplant:
Description

at the time of transplant

Data type

boolean

Alias
UMLS CUI [1]
C3262320
pregnancy
Description

pregnancy test only required for at-risk individuals, defined as female patients of childbearing potential who have received a reduced-intensity conditioning regimen.

Data type

boolean

at the time of allodepleted t cell infusion:
Description

at the time of allodepleted t cell infusion

Data type

boolean

Alias
UMLS CUI [1]
C3897408
gvhd
Description

gvhd

Data type

boolean

Alias
UMLS CUI [1]
C0018133
severe intercurrent infection
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
pregnancy
Description

pregnancy test only required for at-risk individuals, defined as female patients of childbearing potential who have received a reduced-intensity conditioning regimen.

Data type

boolean

Alias
UMLS CUI [1]
C0549206
other investigational drugs in the prior 30 days
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Acute Lymphoblastic Leukemia NCT00710892

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
time of transplant
Item
at the time of transplant:
boolean
C3262320 (UMLS CUI [1])
age
Item
patients (up to 65 years of age) with:
boolean
C0001779 (UMLS CUI [1])
all or high grade nhl
Item
all or high grade nhl that is stage iii or iv and has relapsed or is considered to be primary refractory disease.
boolean
C0023449 (UMLS CUI [1])
C0024305 (UMLS CUI [2])
myelodysplastic syndrome
Item
myelodysplastic syndrome.
boolean
C3463824 (UMLS CUI [1])
aml after first relapse or with primary refractory disease
Item
aml after first relapse or with primary refractory disease.
boolean
C2367456 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
cml
Item
cml
boolean
C0279899 (UMLS CUI [1])
hemophagocytic lymphohistiocytosis (hlh); familial hemophagocytic lymphohistiocytosis (flh); viral-associated hemophagocytic syndrome (vahs); patients with severe chronic active epstein barr virus infection
Item
hemophagocytic lymphohistiocytosis (hlh); familial hemophagocytic lymphohistiocytosis (flh); viral-associated hemophagocytic syndrome (vahs); patients with severe chronic active epstein barr virus infection (scaebv) with predilection for t or nk cell malignancy; x-linked lymphoproliferative disease (xlp)
boolean
C0024291 (UMLS CUI [1])
C0272199 (UMLS CUI [2])
C0019068 (UMLS CUI [3])
C0549463 (UMLS CUI [4])
C0149678 (UMLS CUI [5])
lack of suitable conventional donor (i.e. 5/6 or 6/6 related, or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease
Item
lack of suitable conventional donor (i.e. 5/6 or 6/6 related, or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor.
boolean
C0013018 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
allodepleted t cell infusion
Item
at the time of allodepleted t cell infusion:
boolean
C3897408 (UMLS CUI [1])
anc
Item
engrafted with anc greater than 500.
boolean
C0948762 (UMLS CUI [1])
must have greater than or equal to 50 percent donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease.
Item
must have greater than or equal to 50 percent donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease.
boolean
C3250865 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
life expectancy
Item
life expectancy greater than 30 days
boolean
C0023671 (UMLS CUI [1])
karnofsky
Item
lansky/karnofsky scores greater than or equal to 60
boolean
C0206065 (UMLS CUI [1])
renal disease
Item
absence of severe renal disease (creatinine greater than 2x normal for age)
boolean
C0022658 (UMLS CUI [1])
liver disease
Item
absence of severe hepatic disease (direct bilirubin greater than 2 mg/dl, or sgot greater than 200
boolean
C0023895 (UMLS CUI [1])
spo2
Item
oxygen saturation greater than 94 percent on room air
boolean
C0428179 (UMLS CUI [1])
informed consent
Item
patient/guardian able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
at the time of transplant
Item
at the time of transplant:
boolean
C3262320 (UMLS CUI [1])
pregnancy
Item
pregnancy
boolean
at the time of allodepleted t cell infusion
Item
at the time of allodepleted t cell infusion:
boolean
C3897408 (UMLS CUI [1])
gvhd
Item
gvhd
boolean
C0018133 (UMLS CUI [1])
infection
Item
severe intercurrent infection
boolean
C0009450 (UMLS CUI [1])
pregnancy
Item
pregnancy
boolean
C0549206 (UMLS CUI [1])
study subject participation status
Item
other investigational drugs in the prior 30 days
boolean
C2348568 (UMLS CUI [1])
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