ID

12787

Beschreibung

Allogeneic Stem Cell Transplant With Clofarabine, Ara-C and TBI for AML and ALL; ODM derived from: https://clinicaltrials.gov/show/NCT00529360

Link

https://clinicaltrials.gov/show/NCT00529360

Stichworte

  1. 21.12.15 21.12.15 -
Hochgeladen am

21. Dezember 2015

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :


Keine Kommentare

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Acute Lymphoblastic Leukemia NCT00529360

Eligibility Acute Lymphoblastic Leukemia NCT00529360

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: patients must be <30 years of age.
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
disease status: all in relapse, induction failure, cr3, or cr3p (part a only); aml in relapse, induction failure, cr3, or cr3p (part a only); all in cr3 or cr3p (part a and part b); aml in cr3 or cr3p (part a and bonly); cr3/cr3p must be documented by bone marrow and cns assessment within 14 days of initiation of the pre-transplant conditioning regimen.
Beschreibung

all or aml relapse

Datentyp

boolean

Alias
UMLS CUI [1]
C2367454
UMLS CUI [2]
C0278780
creatinine clearance >40 ml/min/m2 or >60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (gfr) as determined by the institutional normal range or serum creatinine based on age
Beschreibung

creatinine clearance

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
adequate liver function defined as: total bilirubin <2.5 mg/dl l, or sgot (ast) or sgpt (alt) <5 x upper limit of normal
Beschreibung

liver function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
adequate cardiac function defined as: shortening fraction >27 percent by echocardiogram, or ejection fraction of >50 percent by radionuclide angiogram or echocardiogram.
Beschreibung

cardiac function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232164
adequate pulmonary function defined as: corrected dlco >60 percent by pulmonary function test; for children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94 percent on room air.
Beschreibung

pulmonary function

Datentyp

boolean

Alias
UMLS CUI [1]
C0231921
performance status: for patients age 1-16 years, lansky score of >60; for patients > 16 years, karnofsky score of >60.
Beschreibung

karnofsky/lansky performance score

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
patients must have received a minimum of one round of re-induction and one round of consolidation chemotherapy after relapse #2
Beschreibung

consolidation chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C3179017
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with prior myeloablative allogeneic stem cell transplantation and /or tbi.
Beschreibung

myeloablative allogeneic stem cell transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C2242529
females who are pregnant (positive hcg) or lactating.
Beschreibung

pregnant or breastfeeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0549206
UMLS CUI [1,2]
C0006147
karnofsky <60 percent or lansky <60 percent if less than 16 years of age
Beschreibung

karnofsky/lansky performance score

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
age >30 years of age
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
any patient with uncontrolled infection prior to study entry
Beschreibung

uncontrolled infection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205318
UMLS CUI [1,2]
C0009450
patients with evidence of active disease.
Beschreibung

active disease

Datentyp

boolean

Alias
UMLS CUI [1]
C2707252
patients with down syndrome are excluded
Beschreibung

down syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0013080

Ähnliche Modelle

Eligibility Acute Lymphoblastic Leukemia NCT00529360

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age: patients must be <30 years of age.
boolean
C0001779 (UMLS CUI [1])
all or aml relapse
Item
disease status: all in relapse, induction failure, cr3, or cr3p (part a only); aml in relapse, induction failure, cr3, or cr3p (part a only); all in cr3 or cr3p (part a and part b); aml in cr3 or cr3p (part a and bonly); cr3/cr3p must be documented by bone marrow and cns assessment within 14 days of initiation of the pre-transplant conditioning regimen.
boolean
C2367454 (UMLS CUI [1])
C0278780 (UMLS CUI [2])
creatinine clearance
Item
creatinine clearance >40 ml/min/m2 or >60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (gfr) as determined by the institutional normal range or serum creatinine based on age
boolean
C0373595 (UMLS CUI [1])
liver function
Item
adequate liver function defined as: total bilirubin <2.5 mg/dl l, or sgot (ast) or sgpt (alt) <5 x upper limit of normal
boolean
C0232741 (UMLS CUI [1])
cardiac function
Item
adequate cardiac function defined as: shortening fraction >27 percent by echocardiogram, or ejection fraction of >50 percent by radionuclide angiogram or echocardiogram.
boolean
C0232164 (UMLS CUI [1])
pulmonary function
Item
adequate pulmonary function defined as: corrected dlco >60 percent by pulmonary function test; for children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94 percent on room air.
boolean
C0231921 (UMLS CUI [1])
karnofsky/lansky performance score
Item
performance status: for patients age 1-16 years, lansky score of >60; for patients > 16 years, karnofsky score of >60.
boolean
C0206065 (UMLS CUI [1])
consolidation chemotherapy
Item
patients must have received a minimum of one round of re-induction and one round of consolidation chemotherapy after relapse #2
boolean
C3179017 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
myeloablative allogeneic stem cell transplantation
Item
patients with prior myeloablative allogeneic stem cell transplantation and /or tbi.
boolean
C2242529 (UMLS CUI [1])
pregnant or breastfeeding
Item
females who are pregnant (positive hcg) or lactating.
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
karnofsky/lansky performance score
Item
karnofsky <60 percent or lansky <60 percent if less than 16 years of age
boolean
C0206065 (UMLS CUI [1])
age
Item
age >30 years of age
boolean
C0001779 (UMLS CUI [1])
uncontrolled infection
Item
any patient with uncontrolled infection prior to study entry
boolean
C0205318 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
active disease
Item
patients with evidence of active disease.
boolean
C2707252 (UMLS CUI [1])
down syndrome
Item
patients with down syndrome are excluded
boolean
C0013080 (UMLS CUI [1])

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video