ID

12783

Beschrijving

T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts; ODM derived from: https://clinicaltrials.gov/show/NCT00368355

Link

https://clinicaltrials.gov/show/NCT00368355

Trefwoorden

Versies (1)
  1. 21-12-15 21-12-15 -
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21 december 2015

DOI

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Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT00368355

Engels

Eligibility Acute Lymphoblastic Leukemia NCT00368355

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0375877
UMLS CUI [2]
C1335499
age less than or equal to 55 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients with high risk all in cr1 or all or high grade (stage iii or iv) nhl after first relapse or with primary refractory disease or minimal residual diseases.
Beschrijving

patients with high risk all in cr1 or all or high grade (stage iii or iv) nhl

Datatype

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0024305
myelodysplastic syndrome
Beschrijving

myelodysplastic syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C3463824
patients with high risk aml in cr1 (complement receptor 1) or after first relapse or with primary refractory disease or minimal residual disease.
Beschrijving

patients with high risk aml in cr1

Datatype

boolean

Alias
UMLS CUI [1]
C0009552
UMLS CUI [2]
C0684030
UMLS CUI [3]
C0023467
cml
Beschrijving

cml

Datatype

boolean

Alias
UMLS CUI [1]
C0023474
hemophagocytic lymphohistiocytosis (hlh), familial hemophagocytic lymphohistiocytosis (flh), viral-associated hemophagocytic syndrome (vahs), x-linked lymphoproliferative disease (xlp), severe chronic active epstein barr virus infection (scaebv) with predilection for t- or nk-cell malignancy
Beschrijving

hemophagocytic lymphohistiocytosis (hlh), familial hemophagocytic lymphohistiocytosis (flh), viral-associated hemophagocytic syndrome (vahs), x-linked lymphoproliferative disease (xlp), severe chronic active epstein barr virus infection

Datatype

boolean

Alias
UMLS CUI [1]
C0024291
UMLS CUI [2]
C0272199
UMLS CUI [3]
C0019068
UMLS CUI [4]
C0549463
UMLS CUI [5]
C0149678
donor cells should be collected and frozen before conditioning starts
Beschrijving

stem cell harvest

Datatype

boolean

Alias
UMLS CUI [1]
C0411265
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a life expectancy (< / = 6 weeks) limited by diseases other than leukemia
Beschrijving

life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction < 25%)
Beschrijving

cardiac disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
patients with severe renal disease (i.e., creatinine clearance less than 40 cc/1.73 m^2)
Beschrijving

renal disease

Datatype

boolean

Alias
UMLS CUI [1]
C0022658
patients with pre-existing severe restrictive pulmonary disease (fvc less than 40 percent of predicted)
Beschrijving

restrictive pulmonary disease

Datatype

boolean

Alias
UMLS CUI [1]
C0877013
patients with severe hepatic disease (direct bilirubin greater than 3 ug/dl or sgpt (serum glutamic-pyruvic transaminase) greater than 500 ug/dl)
Beschrijving

hepatic disease

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
patients with severe personality disorder or mental illness
Beschrijving

patients with severe personality disorder or mental illness

Datatype

boolean

Alias
UMLS CUI [1]
C0349274
UMLS CUI [2]
C0004936
patients with a severe infection that on evaluation by the principal investigator precludes ablative chemotherapy or successful transplantation
Beschrijving

severe infection

Datatype

boolean

Alias
UMLS CUI [1]
C0853848
patients with documented hiv positivity
Beschrijving

hiv positivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
'high risk' all or aml refers to those acute leukemias identified by the presence of specific biologic features, which predict high likelihood of failure to conventional chemotherapy. as biologic features of high risk disease evolve with improvement of conventional chemotherapy, it is not practical to define this indication with any further specificity. therefore, high risk aml/all will be determined by the primary physician.
Beschrijving

high risk aml/all will be determined by the primary physician

Datatype

boolean

Alias
UMLS CUI [1]
C0684030
UMLS CUI [2]
C0023449
UMLS CUI [3]
C0023467
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Similar models

Eligibility Acute Lymphoblastic Leukemia NCT00368355

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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
C0375877 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
Age
Item
age less than or equal to 55 years of age
boolean
C0001779 (UMLS CUI [1])
patients with high risk all in cr1 or all or high grade (stage iii or iv) nhl
Item
patients with high risk all in cr1 or all or high grade (stage iii or iv) nhl after first relapse or with primary refractory disease or minimal residual diseases.
boolean
C0023449 (UMLS CUI [1])
C0024305 (UMLS CUI [2])
myelodysplastic syndrome
Item
myelodysplastic syndrome
boolean
C3463824 (UMLS CUI [1])
patients with high risk aml in cr1
Item
patients with high risk aml in cr1 (complement receptor 1) or after first relapse or with primary refractory disease or minimal residual disease.
boolean
C0009552 (UMLS CUI [1])
C0684030 (UMLS CUI [2])
C0023467 (UMLS CUI [3])
cml
Item
cml
boolean
C0023474 (UMLS CUI [1])
hemophagocytic lymphohistiocytosis (hlh), familial hemophagocytic lymphohistiocytosis (flh), viral-associated hemophagocytic syndrome (vahs), x-linked lymphoproliferative disease (xlp), severe chronic active epstein barr virus infection
Item
hemophagocytic lymphohistiocytosis (hlh), familial hemophagocytic lymphohistiocytosis (flh), viral-associated hemophagocytic syndrome (vahs), x-linked lymphoproliferative disease (xlp), severe chronic active epstein barr virus infection (scaebv) with predilection for t- or nk-cell malignancy
boolean
C0024291 (UMLS CUI [1])
C0272199 (UMLS CUI [2])
C0019068 (UMLS CUI [3])
C0549463 (UMLS CUI [4])
C0149678 (UMLS CUI [5])
stem cell harvest
Item
donor cells should be collected and frozen before conditioning starts
boolean
C0411265 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
life expectancy
Item
patients with a life expectancy (< / = 6 weeks) limited by diseases other than leukemia
boolean
C0023671 (UMLS CUI [1])
cardiac disease
Item
patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction < 25%)
boolean
C0018799 (UMLS CUI [1])
renal disease
Item
patients with severe renal disease (i.e., creatinine clearance less than 40 cc/1.73 m^2)
boolean
C0022658 (UMLS CUI [1])
restrictive pulmonary disease
Item
patients with pre-existing severe restrictive pulmonary disease (fvc less than 40 percent of predicted)
boolean
C0877013 (UMLS CUI [1])
hepatic disease
Item
patients with severe hepatic disease (direct bilirubin greater than 3 ug/dl or sgpt (serum glutamic-pyruvic transaminase) greater than 500 ug/dl)
boolean
C0023895 (UMLS CUI [1])
patients with severe personality disorder or mental illness
Item
patients with severe personality disorder or mental illness
boolean
C0349274 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
severe infection
Item
patients with a severe infection that on evaluation by the principal investigator precludes ablative chemotherapy or successful transplantation
boolean
C0853848 (UMLS CUI [1])
hiv positivity
Item
patients with documented hiv positivity
boolean
C0019699 (UMLS CUI [1])
high risk aml/all will be determined by the primary physician
Item
'high risk' all or aml refers to those acute leukemias identified by the presence of specific biologic features, which predict high likelihood of failure to conventional chemotherapy. as biologic features of high risk disease evolve with improvement of conventional chemotherapy, it is not practical to define this indication with any further specificity. therefore, high risk aml/all will be determined by the primary physician.
boolean
C0684030 (UMLS CUI [1])
C0023449 (UMLS CUI [2])
C0023467 (UMLS CUI [3])
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