ID

12811

Beschreibung

Trial to Assess the Efficacy of a TCR Alfa Beta Depleted Graft in Pediatric Affected by ALL or AML and Receiving an HSCT; ODM derived from: https://clinicaltrials.gov/show/NCT01810120

Link

https://clinicaltrials.gov/show/NCT01810120

Stichworte

  1. 21.12.15 21.12.15 -
Hochgeladen am

21. Dezember 2015

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Acute Lymphoblastic Leukemia NCT01810120

Eligibility Acute Lymphoblastic Leukemia NCT01810120

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients aged ≥ 3 months and < 21 years
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patients diagnosed with malignant hemopathies (acute lymphoblastic leukemia (all), acute myeloid leukemia (aml), non-hodgkin lymphoma (nhl)) in complete morphological remission or myelodysplastic syndromes (mds), solid tumors or non malignant hematological disorders (scid, acquired and congenital aplastic anemia, other primary immunodeficiencies, life-threatening cytopenia) eligible for an allogeneic transplantation and lacking a related or unrelated hla-matched donor
Beschreibung

eligible for allogeneic stem cell transplant lacking stem cell donor

Datentyp

boolean

Alias
UMLS CUI [1]
C0013893
UMLS CUI [2]
C1456094
UMLS CUI [3]
C0375877
patients displaying an hla-partially matched family donor
Beschreibung

patients displaying an hla-partially matched family donor

Datentyp

boolean

Alias
UMLS CUI [1]
C0375877
lansky/karnofsky score > 40, who > 4
Beschreibung

lansky/karnofsky score > 40, who > 4

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1298650
signed written informed consent
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
grade >ii acute gvhd or chronic extensive gvhd at the time of inclusion
Beschreibung

graft versus host disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018133
patient receiving an immunosuppressive treatment for gvhd treatment at the time of inclusion
Beschreibung

immunosuppressive treatment for gvhd treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0278845
dysfunction of liver (alt/ast > 5 times normal value, or bilirubin > 3 times normal value), or of renal function (creatinine clearance < 30 ml / min)
Beschreibung

renal dysfunction or dysfunction of liver

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C3279454
severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction <40percent)
Beschreibung

cardiovascular disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
current active infectious disease (including positive hiv serology or viral rna)
Beschreibung

infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
serious concurrent uncontrolled medical disorder
Beschreibung

Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
pregnant or breast feeding female patient
Beschreibung

pregnant or breastfeeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
lack of parents' informed consent.
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430

Ähnliche Modelle

Eligibility Acute Lymphoblastic Leukemia NCT01810120

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
patients aged ≥ 3 months and < 21 years
boolean
C0001779 (UMLS CUI [1])
eligible for allogeneic stem cell transplant lacking stem cell donor
Item
patients diagnosed with malignant hemopathies (acute lymphoblastic leukemia (all), acute myeloid leukemia (aml), non-hodgkin lymphoma (nhl)) in complete morphological remission or myelodysplastic syndromes (mds), solid tumors or non malignant hematological disorders (scid, acquired and congenital aplastic anemia, other primary immunodeficiencies, life-threatening cytopenia) eligible for an allogeneic transplantation and lacking a related or unrelated hla-matched donor
boolean
C0013893 (UMLS CUI [1])
C1456094 (UMLS CUI [2])
C0375877 (UMLS CUI [3])
patients displaying an hla-partially matched family donor
Item
patients displaying an hla-partially matched family donor
boolean
C0375877 (UMLS CUI [1])
lansky/karnofsky score > 40, who > 4
Item
lansky/karnofsky score > 40, who > 4
boolean
C0206065 (UMLS CUI [1])
C1298650 (UMLS CUI [2])
informed consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
graft versus host disease
Item
grade >ii acute gvhd or chronic extensive gvhd at the time of inclusion
boolean
C0018133 (UMLS CUI [1])
immunosuppressive treatment for gvhd treatment
Item
patient receiving an immunosuppressive treatment for gvhd treatment at the time of inclusion
boolean
C0021079 (UMLS CUI [1])
C0278845 (UMLS CUI [2])
renal dysfunction or dysfunction of liver
Item
dysfunction of liver (alt/ast > 5 times normal value, or bilirubin > 3 times normal value), or of renal function (creatinine clearance < 30 ml / min)
boolean
C0086565 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
cardiovascular disease
Item
severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction <40percent)
boolean
C0007222 (UMLS CUI [1])
infection
Item
current active infectious disease (including positive hiv serology or viral rna)
boolean
C0009450 (UMLS CUI [1])
Comorbidity
Item
serious concurrent uncontrolled medical disorder
boolean
C0009488 (UMLS CUI [1])
pregnant or breastfeeding
Item
pregnant or breast feeding female patient
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
informed consent
Item
lack of parents' informed consent.
boolean
C0021430 (UMLS CUI [1])

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