ID

22004

Beskrivning

Adoptive Immunotherapy of High Risk Acute Myeloblastic Leukemia Patients Using Haploidentical Kir Ligand-mismatched Natural Killer Cells; ODM derived from: https://clinicaltrials.gov/show/NCT00799799

Länk

https://clinicaltrials.gov/show/NCT00799799

Nyckelord

Versioner (1)
  1. 2017-05-14 2017-05-14 -
Uppladdad den

14 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Myeloblastic Leukemia NCT00799799

Engelsk

Eligibility Myeloblastic Leukemia NCT00799799

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
performance status ≥ 70% (karnofsky score) or ≤ 2 (who).
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
age greater than 18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
availability of a kir incompatible haploidentical donor.
Beskrivning

KIR incompatible Haploidentical donor Available

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0665952
UMLS CUI [1,2]
C0427679
UMLS CUI [1,3]
C3829897
UMLS CUI [1,4]
C0470187
adequate renal (serum creatinine < 2 mg/dl), pulmonary (sat o2 ≥ 96%) and hepatic (alt/ast < 2.5 x n) function.
Beskrivning

Renal function | Creatinine measurement, serum | Pulmonary function | Oxygen saturation measurement | Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0231921
UMLS CUI [4]
C0523807
UMLS CUI [5]
C0232741
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201899
patients enrolled in the protocol must have an autologous graft cryopreserved to be reinfused in case of severe myelosuppression induced by haploidentical nk cells. back-up cells will be reinfused in case of anc < 0.5 x 109/l at day + 40 from the start of immunosuppressive regimen.
Beskrivning

Autograft Material Cryopreserved Available | Severe Myelosuppression NK Cells Haploidentical Induced | Reinfusion | Absolute neutrophil count | Therapeutic immunosuppression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0559189
UMLS CUI [1,2]
C0010405
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C2985509
UMLS CUI [2,2]
C0022688
UMLS CUI [2,3]
C3829897
UMLS CUI [2,4]
C0205263
UMLS CUI [3]
C0854643
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0021079
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
age < 18.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
people unable to give informed consent.
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
hiv positivity.
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
hcv positivity with high viral load.
Beskrivning

Hepatitis C virus test positive | Viral load increased

Datatyp

boolean

Alias
UMLS CUI [1]
C2748185
UMLS CUI [2]
C0877186
intercurrent organ damage or medical problems that would interfere with therapy.
Beskrivning

Organ Damage Interferes with Therapeutic procedure | Medical Problem Interferes with Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C1883709
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C1254481
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0087111
pregnant or nursing females.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
current uncontrolled infection.
Beskrivning

Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
no availability of a cryopreserved autologous stem cell graft to be reinfused in case of severe myelosuppression.
Beskrivning

Autograft Material Stem cells Cryopreserved Unavailable | Severe Myelosuppression | Reinfusion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0559189
UMLS CUI [1,2]
C0038250
UMLS CUI [1,3]
C0010405
UMLS CUI [1,4]
C0686905
UMLS CUI [2]
C2985509
UMLS CUI [3]
C0854643
signs or symptoms of fluid retention (e.g. pleural effusion)
Beskrivning

Body fluid retention Sign or Symptom | Pleural effusion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0268000
UMLS CUI [1,2]
C3540840
UMLS CUI [2]
C0032227
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Similar models

Eligibility Myeloblastic Leukemia NCT00799799

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Karnofsky Performance Status
Item
performance status ≥ 70% (karnofsky score) or ≤ 2 (who).
boolean
C0206065 (UMLS CUI [1])
Age
Item
age greater than 18 years.
boolean
C0001779 (UMLS CUI [1])
KIR incompatible Haploidentical donor Available
Item
availability of a kir incompatible haploidentical donor.
boolean
C0665952 (UMLS CUI [1,1])
C0427679 (UMLS CUI [1,2])
C3829897 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,4])
Renal function | Creatinine measurement, serum | Pulmonary function | Oxygen saturation measurement | Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
adequate renal (serum creatinine < 2 mg/dl), pulmonary (sat o2 ≥ 96%) and hepatic (alt/ast < 2.5 x n) function.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0231921 (UMLS CUI [3])
C0523807 (UMLS CUI [4])
C0232741 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
Autograft Material Cryopreserved Available | Severe Myelosuppression NK Cells Haploidentical Induced | Reinfusion | Absolute neutrophil count | Therapeutic immunosuppression
Item
patients enrolled in the protocol must have an autologous graft cryopreserved to be reinfused in case of severe myelosuppression induced by haploidentical nk cells. back-up cells will be reinfused in case of anc < 0.5 x 109/l at day + 40 from the start of immunosuppressive regimen.
boolean
C0559189 (UMLS CUI [1,1])
C0010405 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C2985509 (UMLS CUI [2,1])
C0022688 (UMLS CUI [2,2])
C3829897 (UMLS CUI [2,3])
C0205263 (UMLS CUI [2,4])
C0854643 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0021079 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Age
Item
age < 18.
boolean
C0001779 (UMLS CUI [1])
Informed Consent Unable
Item
people unable to give informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
HIV Seropositivity
Item
hiv positivity.
boolean
C0019699 (UMLS CUI [1])
Hepatitis C virus test positive | Viral load increased
Item
hcv positivity with high viral load.
boolean
C2748185 (UMLS CUI [1])
C0877186 (UMLS CUI [2])
Organ Damage Interferes with Therapeutic procedure | Medical Problem Interferes with Therapeutic procedure
Item
intercurrent organ damage or medical problems that would interfere with therapy.
boolean
C0178784 (UMLS CUI [1,1])
C1883709 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C1254481 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Communicable Disease Uncontrolled
Item
current uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Autograft Material Stem cells Cryopreserved Unavailable | Severe Myelosuppression | Reinfusion
Item
no availability of a cryopreserved autologous stem cell graft to be reinfused in case of severe myelosuppression.
boolean
C0559189 (UMLS CUI [1,1])
C0038250 (UMLS CUI [1,2])
C0010405 (UMLS CUI [1,3])
C0686905 (UMLS CUI [1,4])
C2985509 (UMLS CUI [2])
C0854643 (UMLS CUI [3])
Body fluid retention Sign or Symptom | Pleural effusion
Item
signs or symptoms of fluid retention (e.g. pleural effusion)
boolean
C0268000 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
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