Information:
Fel:
ID
12787
Beskrivning
Allogeneic Stem Cell Transplant With Clofarabine, Ara-C and TBI for AML and ALL; ODM derived from: https://clinicaltrials.gov/show/NCT00529360
Länk
https://clinicaltrials.gov/show/NCT00529360
Nyckelord
Versioner (1)
- 2015-12-21 2015-12-21 -
Uppladdad den
21 december 2015
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT00529360
Eligibility Acute Lymphoblastic Leukemia NCT00529360
- StudyEvent: Eligibility
Similar models
Eligibility Acute Lymphoblastic Leukemia NCT00529360
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
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])
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])