ID

14003

Beschrijving

Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy; ODM derived from: https://clinicaltrials.gov/show/NCT01819558

Link

https://clinicaltrials.gov/show/NCT01819558

Trefwoorden

  1. 21-03-16 21-03-16 -
Geüploaded op

21 maart 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Acute Myeloid Leukemia NCT01819558

Eligibility Acute Myeloid Leukemia NCT01819558

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patients older than 18 and younger than 65 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Karnofsky Performance Status ≥ 70 %
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, who underwent allogeneic stem cell transplantation from hla-identical donor (related or unrelated) after reduced-intensity conditioning regimen.
Beschrijving

Allogeneic Hematopoietic Stem Cell Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C1705576
Patients in morphologic complete remission at the time of transplantation.
Beschrijving

Complete remission

Datatype

boolean

Alias
UMLS CUI [1]
C0677874
Wt1 expression detectable on tumor cells.
Beschrijving

WT1 gene

Datatype

boolean

Alias
UMLS CUI [1]
C0694898
Expected life duration more than 6 months.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
Creatinine clearance ≥ 50 ml/min
Beschrijving

Creatinine clearance

Datatype

boolean

Alias
UMLS CUI [1]
C0812399
Bilirubinemia < 1.5n and asat < 2.5n
Beschrijving

Bilirubinemia

Datatype

boolean

Alias
UMLS CUI [1]
C0020433
Women of childbearing age: negative pregnancy test and effective contraception for at least 30 days before vaccinal immunotherapy (the same contraceptive method must be continued at least 2 months after the last vaccine infusion).
Beschrijving

Negative pregnancy test and effective contraception

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
UMLS CUI [2]
C0700589
Membership of a social security scheme or beneficiary of such a regime.
Beschrijving

Social Security

Datatype

boolean

Alias
UMLS CUI [1]
C0037435
Signed inform consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
Patients with severe and uncontrolled affections, especially active graft-versus-host disease requiring steroid treatment (>0.3 mg/kg/j) and/or mycophenolate mofetil.
Beschrijving

Graft-vs-Host Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018133
Pregnant or lactating women
Beschrijving

Pregnant or lactating women

Datatype

boolean

Alias
UMLS CUI [1]
C3242212
HIV Seropositivity
Beschrijving

HIV positive

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
Autoimmune disease (lupus, multiple sclerosis, chrone disease)
Beschrijving

Autoimmune Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0004364
Previous history of allergic state which could be potentially compound by a component of the vaccinal immunotherapy.
Beschrijving

Allergic disposition

Datatype

boolean

Alias
UMLS CUI [1]
C3539909
Patients who received (or are planned to receive) another experimental treatment within 30 days following the first infusion of the experimental drug of this protocol.
Beschrijving

Experimental treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0015320
Previous history of another cancer, except if considered as probably cured by the investigator.
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
Patients deprived of liberty, or under guardianship.
Beschrijving

Gardianship

Datatype

boolean

Alias
UMLS CUI [1]
C0870627

Similar models

Eligibility Acute Myeloid Leukemia NCT01819558

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Patients older than 18 and younger than 65 years.
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
Karnofsky Performance Status ≥ 70 %
boolean
C0206065 (UMLS CUI [1])
Allogeneic Hematopoietic Stem Cell Transplantation
Item
Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, who underwent allogeneic stem cell transplantation from hla-identical donor (related or unrelated) after reduced-intensity conditioning regimen.
boolean
C1705576 (UMLS CUI [1])
Complete remission
Item
Patients in morphologic complete remission at the time of transplantation.
boolean
C0677874 (UMLS CUI [1])
WT1 gene
Item
Wt1 expression detectable on tumor cells.
boolean
C0694898 (UMLS CUI [1])
Life Expectancy
Item
Expected life duration more than 6 months.
boolean
C0023671 (UMLS CUI [1])
Creatinine clearance
Item
Creatinine clearance ≥ 50 ml/min
boolean
C0812399 (UMLS CUI [1])
Bilirubinemia
Item
Bilirubinemia < 1.5n and asat < 2.5n
boolean
C0020433 (UMLS CUI [1])
Negative pregnancy test and effective contraception
Item
Women of childbearing age: negative pregnancy test and effective contraception for at least 30 days before vaccinal immunotherapy (the same contraceptive method must be continued at least 2 months after the last vaccine infusion).
boolean
C0427780 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Social Security
Item
Membership of a social security scheme or beneficiary of such a regime.
boolean
C0037435 (UMLS CUI [1])
Informed Consent
Item
Signed inform consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Graft-vs-Host Disease
Item
Patients with severe and uncontrolled affections, especially active graft-versus-host disease requiring steroid treatment (>0.3 mg/kg/j) and/or mycophenolate mofetil.
boolean
C0018133 (UMLS CUI [1])
Pregnant or lactating women
Item
Pregnant or lactating women
boolean
C3242212 (UMLS CUI [1])
HIV positive
Item
HIV Seropositivity
boolean
C0019699 (UMLS CUI [1])
Autoimmune Diseases
Item
Autoimmune disease (lupus, multiple sclerosis, chrone disease)
boolean
C0004364 (UMLS CUI [1])
Allergic disposition
Item
Previous history of allergic state which could be potentially compound by a component of the vaccinal immunotherapy.
boolean
C3539909 (UMLS CUI [1])
Experimental treatment
Item
Patients who received (or are planned to receive) another experimental treatment within 30 days following the first infusion of the experimental drug of this protocol.
boolean
C0087111 (UMLS CUI [1,1])
C0015320 (UMLS CUI [1,2])
Malignant Neoplasms
Item
Previous history of another cancer, except if considered as probably cured by the investigator.
boolean
C0006826 (UMLS CUI [1])
Gardianship
Item
Patients deprived of liberty, or under guardianship.
boolean
C0870627 (UMLS CUI [1])

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