ID

22004

Description

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

Link

https://clinicaltrials.gov/show/NCT00799799

Keywords

Versions (1)
  1. 5/14/17 5/14/17 -
Uploaded on

May 14, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Myeloblastic Leukemia NCT00799799

English

Eligibility Myeloblastic Leukemia NCT00799799

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent.
Description

Informed Consent

Data type

boolean

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

Karnofsky Performance Status

Data type

boolean

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

Age

Data type

boolean

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

KIR incompatible Haploidentical donor Available

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
age < 18.
Description

Age

Data type

boolean

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

Informed Consent Unable

Data type

boolean

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

HIV Seropositivity

Data type

boolean

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

Hepatitis C virus test positive | Viral load increased

Data type

boolean

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

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

Data type

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.
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Communicable Disease Uncontrolled

Data type

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.
Description

Autograft Material Stem cells Cryopreserved Unavailable | Severe Myelosuppression | Reinfusion

Data type

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)
Description

Body fluid retention Sign or Symptom | Pleural effusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0268000
UMLS CUI [1,2]
C3540840
UMLS CUI [2]
C0032227
Back to the top of the page

Similar models

Eligibility Myeloblastic Leukemia NCT00799799

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial