ID

13799

Beskrivning

Trial of a WT-1 Analog Peptide Vaccine in Patients With Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT01266083

Länk

https://clinicaltrials.gov/show/NCT01266083

Nyckelord

Versioner (1)
  1. 2016-03-07 2016-03-07 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

7 mars 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01266083

Engelsk

Eligibility Acute Myeloid Leukemia NCT01266083

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
morphologic confirmation of a diagnosis of aml or all at mskcc
Beskrivning

AML or ALL

Datatyp

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C0023449
patients will have completed induction therapy, achieved 1st cr and will have completed any planned postremission therapy. patients are not candidates for allogeneic stem cell transplantation. for purposes of this study, patients who are not candidates for allogeneic stem cell transplantation shall be defined as 1) those who do not meet the eligibility criteria of an open allogeneic transplant protocol or 2) those who do not have a suitable available hla matched donor available or 3) those who refuse to undergo stem cell transplantation or 4) those patients whose disease is characterized by "good risk" features (for aml the following cyotogenetic subtypes: t(8;21), inv (16), or t(16;16), t(15;17), normal karyotype with mutated npm1 and negative for tandem duplication of flt-3. for all: t cell phenotype of any b lineage disease exclusive of t(9;22) or t(4;11) in whom allogenic stem cell transplantation in 1st cr would not be offered as standard of care.
Beskrivning

ID.2

Datatyp

boolean

alternatively, those patients greater than or equal to 60 years of age who have achieved 1st cr and in whom no further postremission chemotherapy is planned may be enrolled
Beskrivning

Age, remission

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0677874
UMLS CUI [3]
C0392920
patients must have documented wt1 + disease. for purpose of this study, this is defined as detectable presence of any wt1 transcript via rt-pcr on a bone marrow performed at mskcc within 4 weeks prior to the administration of the first dose of vaccine.
Beskrivning

wt1

Datatyp

boolean

Alias
UMLS CUI [1]
C0694898
UMLS CUI [2]
C0599161
patients must be within 2 years of achieving cr following chemotherapy
Beskrivning

complete remission following chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0677874
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0392920
at least 4 weeks must have elapsed between the patient's last chemotherapy or radiation treatment and the first vaccination.
Beskrivning

time elapsed between last chemotherapy or radiation therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2826303
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0392920
UMLS CUI [1,4]
C1522449
age > or = to 18 years
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance status > or = to 50%
Beskrivning

karnofsky

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
absolute neutrophil count (anc) > or = to 1000/μl
Beskrivning

ANC

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelets > 50k/ μl
Beskrivning

platelets

Datatyp

boolean

Alias
UMLS CUI [1]
C0005821
total bilirubin < or = to 2.0 mg/dl ast and alt < or = to 2.5 x upper limits of normal
Beskrivning

hepatic function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1278039
UMLS CUI [1,2]
C0201836
UMLS CUI [1,3]
C0201899
creatinine < or = to 2.0 mg/dl
Beskrivning

creatinine

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women
Beskrivning

pregnancy or lactation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
patients with documented evidence of leptomeningeal disease
Beskrivning

leptomeningeal disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023418
UMLS CUI [1,2]
C0228126
patients who have undergone autologous or allogeneic stem cell transplantation
Beskrivning

autologous or allogeneic stem cell transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1504389
UMLS CUI [1,2]
C0439859
UMLS CUI [2,1]
C1504389
UMLS CUI [2,2]
C1515895
patients with active infection requiring systemic antimicrobials
Beskrivning

active infection requiring systemic antimicrobials

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1136254
patients taking systemic corticosteroids
Beskrivning

systemic corticosteroids

Datatyp

boolean

Alias
UMLS CUI [1]
C4039704
patients with serious unstable medical illness
Beskrivning

comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
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Similar models

Eligibility Acute Myeloid Leukemia NCT01266083

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
AML or ALL
Item
morphologic confirmation of a diagnosis of aml or all at mskcc
boolean
C0023467 (UMLS CUI [1])
C0023449 (UMLS CUI [2])
ID.2
Item
patients will have completed induction therapy, achieved 1st cr and will have completed any planned postremission therapy. patients are not candidates for allogeneic stem cell transplantation. for purposes of this study, patients who are not candidates for allogeneic stem cell transplantation shall be defined as 1) those who do not meet the eligibility criteria of an open allogeneic transplant protocol or 2) those who do not have a suitable available hla matched donor available or 3) those who refuse to undergo stem cell transplantation or 4) those patients whose disease is characterized by "good risk" features (for aml the following cyotogenetic subtypes: t(8;21), inv (16), or t(16;16), t(15;17), normal karyotype with mutated npm1 and negative for tandem duplication of flt-3. for all: t cell phenotype of any b lineage disease exclusive of t(9;22) or t(4;11) in whom allogenic stem cell transplantation in 1st cr would not be offered as standard of care.
boolean
Age, remission
Item
alternatively, those patients greater than or equal to 60 years of age who have achieved 1st cr and in whom no further postremission chemotherapy is planned may be enrolled
boolean
C0001779 (UMLS CUI [1])
C0677874 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
wt1
Item
patients must have documented wt1 + disease. for purpose of this study, this is defined as detectable presence of any wt1 transcript via rt-pcr on a bone marrow performed at mskcc within 4 weeks prior to the administration of the first dose of vaccine.
boolean
C0694898 (UMLS CUI [1])
C0599161 (UMLS CUI [2])
complete remission following chemotherapy
Item
patients must be within 2 years of achieving cr following chemotherapy
boolean
C0040223 (UMLS CUI [1,1])
C0677874 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,4])
time elapsed between last chemotherapy or radiation therapy
Item
at least 4 weeks must have elapsed between the patient's last chemotherapy or radiation treatment and the first vaccination.
boolean
C2826303 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
age
Item
age > or = to 18 years
boolean
C0001779 (UMLS CUI [1])
karnofsky
Item
karnofsky performance status > or = to 50%
boolean
C0206065 (UMLS CUI [1])
ANC
Item
absolute neutrophil count (anc) > or = to 1000/μl
boolean
C0948762 (UMLS CUI [1])
platelets
Item
platelets > 50k/ μl
boolean
C0005821 (UMLS CUI [1])
hepatic function
Item
total bilirubin < or = to 2.0 mg/dl ast and alt < or = to 2.5 x upper limits of normal
boolean
C1278039 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
C0201899 (UMLS CUI [1,3])
creatinine
Item
creatinine < or = to 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnancy or lactation
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
leptomeningeal disease
Item
patients with documented evidence of leptomeningeal disease
boolean
C0023418 (UMLS CUI [1,1])
C0228126 (UMLS CUI [1,2])
autologous or allogeneic stem cell transplantation
Item
patients who have undergone autologous or allogeneic stem cell transplantation
boolean
C1504389 (UMLS CUI [1,1])
C0439859 (UMLS CUI [1,2])
C1504389 (UMLS CUI [2,1])
C1515895 (UMLS CUI [2,2])
active infection requiring systemic antimicrobials
Item
patients with active infection requiring systemic antimicrobials
boolean
C0009450 (UMLS CUI [1,1])
C1136254 (UMLS CUI [1,2])
systemic corticosteroids
Item
patients taking systemic corticosteroids
boolean
C4039704 (UMLS CUI [1])
comorbidity
Item
patients with serious unstable medical illness
boolean
C0009488 (UMLS CUI [1])
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