ID

30219

Description

Haploidentical Natural Killer (NK) Cells With Epratuzumab for Relapsed Acute Lymphoblastic Leukemia (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT00941928

Link

https://clinicaltrials.gov/show/NCT00941928

Keywords

  1. 5/19/18 5/19/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 19, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Leukemia NCT00941928

Eligibility Leukemia NCT00941928

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00941928
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. recipient inclusion criteria (within 28 days of this protocol's lymphodepleting conditioning regimen and after donor and recipient consent-signing)
Description

Recipient Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C1512693
2. diagnosis of cd22+ acute lymphoblastic leukemia that is a. refractory to therapy or
Description

Acute lymphocytic leukemia CD22 positive refractory

Data type

boolean

Alias
UMLS CUI [1,1]
C0023449
UMLS CUI [1,2]
C0882819
UMLS CUI [1,3]
C0205269
b. in second or greater relapse without other standard therapeutic options
Description

Acute lymphocytic leukemia CD22 positive Relapse Quantity | Standard therapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0023449
UMLS CUI [1,2]
C0882819
UMLS CUI [1,3]
C0035020
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0332197
3. patient may have been the recipient of an allogeneic hematopoietic stem cell transplant; however; there must be no evidence of graft-versus-host disease (gvhd)
Description

Recipient Allogeneic Hematopoietic Stem Cell Transplantation | Graft-vs-Host Disease Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C1705576
UMLS CUI [2,1]
C0018133
UMLS CUI [2,2]
C0332197
4. off prednisone or other immunosuppressive medications for at least 3 days prior to both the lymphodepleting regimen and the nk infusion
Description

Prednisone Discontinued | Immunosuppressive Agents Discontinued | Status pre- Lymphocyte Depletion | Status pre- Natural Killer Cells Infusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0024257
UMLS CUI [4,1]
C0332152
UMLS CUI [4,2]
C0022688
UMLS CUI [4,3]
C0574032
5. zubrod performance scale </= 2 or lansky performance scale >/= 60
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
6. adequate renal function defined as: serum creatinine (cr), for adults </= 2 mg/dl, for children </= 2 mg/dl or </= 2 times upper limit of normal (uln) for age (whichever is less). if abnormal renal function, then cr clearance >/= 60 ml/min/1.73 m^2
Description

Renal function | Creatinine measurement, serum | Adult | Children | Age | Abnormal renal function | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0001675
UMLS CUI [4]
C0008059
UMLS CUI [5]
C0001779
UMLS CUI [6]
C0151746
UMLS CUI [7]
C0373595
7. adequate liver function defined as: total bilirubin </= 2 mg/dl and serum glutamic-pyruvic transaminase (sgpt)/ alanine transaminase(alt) </= 5 * uln for age (unless gilbert's disease or abnormal liver function due to primary disease)
Description

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Age | Exception Gilbert Disease | Exception Liver Dysfunction Due to Primary disorders

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0001779
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0017551
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0086565
UMLS CUI [6,3]
C0678226
UMLS CUI [6,4]
C0277554
8. pulmonary symptoms controlled by medication and pulse oximetry >/= 92% room air
Description

Pulmonary Symptoms Controlled by Pharmaceutical Preparations | Pulse Oximetry on room air

Data type

boolean

Alias
UMLS CUI [1,1]
C0037090
UMLS CUI [1,2]
C0332298
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0034108
UMLS CUI [2,2]
C2709070
9. negative serum test to rule out pregnancy within 2 weeks prior to registration in females of childbearing potential (non childbearing is defined as greater than one year post-menopausal or surgically sterilized
Description

Childbearing Potential Serum pregnancy test negative | Postmenopausal state | Female Sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
10. requirement of sexually active females and males to use any form of contraception considered effective and medically acceptable by the investigator. [acceptable forms: birth control implants, birth control pills, a vasectomy (male surgical sterilization), or a double-barrier method (any 2 of the following in combination: intrauterine device (iud), male or female condom with spermicidal gel, a diaphragm, a sponge, and/or cervical cap)]
Description

Gender Sexually active Contraceptive methods | Contraceptive implant | Contraceptives, Oral | Vasectomy | Male sterilization | Barrier Contraception Double | Intrauterine Devices | Condoms, Male | Female Condoms | Spermatocidal Agents | Vaginal contraceptive diaphragm | Contraceptive Sponge | CERVICAL CAP FOR CONTRACEPTIVE USE

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [2]
C1657106
UMLS CUI [3]
C0009905
UMLS CUI [4]
C0042387
UMLS CUI [5]
C0024559
UMLS CUI [6,1]
C0004764
UMLS CUI [6,2]
C0205173
UMLS CUI [7]
C0021900
UMLS CUI [8]
C0009653
UMLS CUI [9]
C0221829
UMLS CUI [10]
C0037862
UMLS CUI [11]
C0042241
UMLS CUI [12]
C0183461
UMLS CUI [13]
C0493327
11. negative serology for human immunodeficiency virus (hiv)
Description

Serology negative HIV

Data type

boolean

Alias
UMLS CUI [1,1]
C0919674
UMLS CUI [1,2]
C0019682
12. donor must be related to recipient and is predicted to be alloreactive based upon the presence of the relevant kir genes and incompatibility with the recipient for hla c or bw antigens
Description

Donor Related Recipient | Other Coding | KIR gene | Blood incompatible HLA-C Antigens | Blood incompatible HLA-Bw antigen

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0080103
UMLS CUI [1,3]
C1709854
UMLS CUI [2]
C3846158
UMLS CUI [3]
C3171597
UMLS CUI [4,1]
C0427679
UMLS CUI [4,2]
C0019751
UMLS CUI [5,1]
C0427679
UMLS CUI [5,2]
C0312673
13. donor must have infectious disease marker testing [hepatitis b, c, hiv, cmv, syphilis (rpr), chagas, htlv, and west nile virus] and cbc differential and platelet studies that meet standard medical eligibility criteria for allogeneic blood stem cell donation within 7 days of apheresis
Description

Donor Communicable Disease Marker Testing | Hepatitis B | Hepatitis C | HIV Infection | Cytomegalovirus Infection | Syphilis | Rapid Plasma Reagin Measurement | Chagas Disease | T-Cell Leukemia Viruses, Human | West Nile virus | Complete blood count with differential | Whole body platelet study | Criteria Fulfill Allogeneic hematopoietic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0009450
UMLS CUI [1,3]
C0005516
UMLS CUI [1,4]
C0039593
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0019693
UMLS CUI [5]
C0010823
UMLS CUI [6]
C0039128
UMLS CUI [7]
C0201405
UMLS CUI [8]
C0041234
UMLS CUI [9]
C0086427
UMLS CUI [10]
C0043125
UMLS CUI [11]
C0545131
UMLS CUI [12]
C2316857
UMLS CUI [13,1]
C0243161
UMLS CUI [13,2]
C1550543
UMLS CUI [13,3]
C4255274
14. donor, if a female of childbearing potential (non-childbearing is defined as greater than one year post-menopause or surgically sterilized), must have a negative serum test to rule out pregnancy within 14 days of apheresis
Description

Donor Childbearing Potential Serum pregnancy test negative | Postmenopausal state | Female Sterilization | Apheresis

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0430061
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0005791
15. donor must meet standard medical eligibility criteria for allogeneic stem cell donation
Description

Donor Fulfill Criteria Allogeneic hematopoietic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0243161
UMLS CUI [1,4]
C4255274
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. exclusion criteria applies to both the initiation of conditioning regimen and to the nk infusion
Description

Exclusion Criteria Relationships

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0439849
2. active central nervous system (cns) leukemia
Description

Central nervous system leukaemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
3. active infection (defined as on antimicrobial therapy and or febrile)
Description

Communicable Disease | Antimicrobial medicament | Fever

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0443071
UMLS CUI [3]
C0015967
4. breast-feeding females
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
5. currently using a ventilator or requiring supplemental oxygen
Description

On ventilator | Oxygen supplementation Required

Data type

boolean

Alias
UMLS CUI [1]
C2603364
UMLS CUI [2,1]
C0919655
UMLS CUI [2,2]
C1514873
6. currently undergoing dialysis
Description

Dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0011946
7. currently using a phase i, ii, or iii investigational agent. these agents should be stopped within 21 days of nk infusion
Description

Investigational New Drugs To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1272691
8. new detected cardiac arrhythmia not controlled with medical management within prior 72 hour period.
Description

Cardiac Arrhythmia Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205318
9. hypotension requiring pressor support within prior 72 hour period
Description

Hypotension Requirement Pressor support

Data type

boolean

Alias
UMLS CUI [1,1]
C0020649
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0281374
10. uncontrolled infection defined as daily fever greater than or equal to 38.2°c within prior 24 hours and new positive culture for bacteria, fungus, or virus within 72 hours prior to nk -cell infusion, if clinically indicated
Description

Communicable Disease Uncontrolled | Fever recurring daily Degrees Celsius | Culture positive Bacteria | Culture positive Fungi | Culture positive Virus | Indication Natural Killer Cells Infusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C2219980
UMLS CUI [2,2]
C0439237
UMLS CUI [3,1]
C0159125
UMLS CUI [3,2]
C0004611
UMLS CUI [4,1]
C0159125
UMLS CUI [4,2]
C0016832
UMLS CUI [5,1]
C0159125
UMLS CUI [5,2]
C0042776
UMLS CUI [6,1]
C3146298
UMLS CUI [6,2]
C0022688
UMLS CUI [6,3]
C0574032
11. taking corticosteroids by mouth or intravenously within prior 72 hour period
Description

Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1522726
12. ascites requiring paracentesis within prior 72 hour period. (if the patient requires paracentesis within 72 hours of nk cell infusion, they will not be eligible to receive the infusion.)
Description

Ascites Requirement Paracentesis

Data type

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0034115
13. seizure activity or clinically detectable encephalopathy or new focal neurologic deficits within prior 72 hour period
Description

Seizures | Encephalopathy | Neurologic Deficits Focal

Data type

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0085584
UMLS CUI [3,1]
C0521654
UMLS CUI [3,2]
C0205234
14. donor has active infection (defined as on antimicrobial therapy and/or febrile) within 7 days of apheresis
Description

Donor Communicable Disease | Antimicrobial medicament | Fever

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0009450
UMLS CUI [2]
C0443071
UMLS CUI [3]
C0015967
15. donor is pregnant female or breast-feeding female (within 7 days of apheresis)
Description

Donor Pregnancy | Donor Breast Feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0032961
UMLS CUI [2,1]
C0013018
UMLS CUI [2,2]
C0006147

Similar models

Eligibility Leukemia NCT00941928

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00941928
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Recipient Inclusion criteria
Item
1. recipient inclusion criteria (within 28 days of this protocol's lymphodepleting conditioning regimen and after donor and recipient consent-signing)
boolean
C1709854 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Acute lymphocytic leukemia CD22 positive refractory
Item
2. diagnosis of cd22+ acute lymphoblastic leukemia that is a. refractory to therapy or
boolean
C0023449 (UMLS CUI [1,1])
C0882819 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
Acute lymphocytic leukemia CD22 positive Relapse Quantity | Standard therapy Absent
Item
b. in second or greater relapse without other standard therapeutic options
boolean
C0023449 (UMLS CUI [1,1])
C0882819 (UMLS CUI [1,2])
C0035020 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C2936643 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Recipient Allogeneic Hematopoietic Stem Cell Transplantation | Graft-vs-Host Disease Absent
Item
3. patient may have been the recipient of an allogeneic hematopoietic stem cell transplant; however; there must be no evidence of graft-versus-host disease (gvhd)
boolean
C1709854 (UMLS CUI [1,1])
C1705576 (UMLS CUI [1,2])
C0018133 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Prednisone Discontinued | Immunosuppressive Agents Discontinued | Status pre- Lymphocyte Depletion | Status pre- Natural Killer Cells Infusion
Item
4. off prednisone or other immunosuppressive medications for at least 3 days prior to both the lymphodepleting regimen and the nk infusion
boolean
C0032952 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C0024257 (UMLS CUI [3,2])
C0332152 (UMLS CUI [4,1])
C0022688 (UMLS CUI [4,2])
C0574032 (UMLS CUI [4,3])
Zubrod Performance Status
Item
5. zubrod performance scale </= 2 or lansky performance scale >/= 60
boolean
C3714786 (UMLS CUI [1])
Renal function | Creatinine measurement, serum | Adult | Children | Age | Abnormal renal function | Creatinine clearance measurement
Item
6. adequate renal function defined as: serum creatinine (cr), for adults </= 2 mg/dl, for children </= 2 mg/dl or </= 2 times upper limit of normal (uln) for age (whichever is less). if abnormal renal function, then cr clearance >/= 60 ml/min/1.73 m^2
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0001675 (UMLS CUI [3])
C0008059 (UMLS CUI [4])
C0001779 (UMLS CUI [5])
C0151746 (UMLS CUI [6])
C0373595 (UMLS CUI [7])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Age | Exception Gilbert Disease | Exception Liver Dysfunction Due to Primary disorders
Item
7. adequate liver function defined as: total bilirubin </= 2 mg/dl and serum glutamic-pyruvic transaminase (sgpt)/ alanine transaminase(alt) </= 5 * uln for age (unless gilbert's disease or abnormal liver function due to primary disease)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0017551 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0086565 (UMLS CUI [6,2])
C0678226 (UMLS CUI [6,3])
C0277554 (UMLS CUI [6,4])
Pulmonary Symptoms Controlled by Pharmaceutical Preparations | Pulse Oximetry on room air
Item
8. pulmonary symptoms controlled by medication and pulse oximetry >/= 92% room air
boolean
C0037090 (UMLS CUI [1,1])
C0332298 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0034108 (UMLS CUI [2,1])
C2709070 (UMLS CUI [2,2])
Childbearing Potential Serum pregnancy test negative | Postmenopausal state | Female Sterilization
Item
9. negative serum test to rule out pregnancy within 2 weeks prior to registration in females of childbearing potential (non childbearing is defined as greater than one year post-menopausal or surgically sterilized
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
Gender Sexually active Contraceptive methods | Contraceptive implant | Contraceptives, Oral | Vasectomy | Male sterilization | Barrier Contraception Double | Intrauterine Devices | Condoms, Male | Female Condoms | Spermatocidal Agents | Vaginal contraceptive diaphragm | Contraceptive Sponge | CERVICAL CAP FOR CONTRACEPTIVE USE
Item
10. requirement of sexually active females and males to use any form of contraception considered effective and medically acceptable by the investigator. [acceptable forms: birth control implants, birth control pills, a vasectomy (male surgical sterilization), or a double-barrier method (any 2 of the following in combination: intrauterine device (iud), male or female condom with spermicidal gel, a diaphragm, a sponge, and/or cervical cap)]
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C1657106 (UMLS CUI [2])
C0009905 (UMLS CUI [3])
C0042387 (UMLS CUI [4])
C0024559 (UMLS CUI [5])
C0004764 (UMLS CUI [6,1])
C0205173 (UMLS CUI [6,2])
C0021900 (UMLS CUI [7])
C0009653 (UMLS CUI [8])
C0221829 (UMLS CUI [9])
C0037862 (UMLS CUI [10])
C0042241 (UMLS CUI [11])
C0183461 (UMLS CUI [12])
C0493327 (UMLS CUI [13])
Serology negative HIV
Item
11. negative serology for human immunodeficiency virus (hiv)
boolean
C0919674 (UMLS CUI [1,1])
C0019682 (UMLS CUI [1,2])
Donor Related Recipient | Other Coding | KIR gene | Blood incompatible HLA-C Antigens | Blood incompatible HLA-Bw antigen
Item
12. donor must be related to recipient and is predicted to be alloreactive based upon the presence of the relevant kir genes and incompatibility with the recipient for hla c or bw antigens
boolean
C0013018 (UMLS CUI [1,1])
C0080103 (UMLS CUI [1,2])
C1709854 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
C3171597 (UMLS CUI [3])
C0427679 (UMLS CUI [4,1])
C0019751 (UMLS CUI [4,2])
C0427679 (UMLS CUI [5,1])
C0312673 (UMLS CUI [5,2])
Donor Communicable Disease Marker Testing | Hepatitis B | Hepatitis C | HIV Infection | Cytomegalovirus Infection | Syphilis | Rapid Plasma Reagin Measurement | Chagas Disease | T-Cell Leukemia Viruses, Human | West Nile virus | Complete blood count with differential | Whole body platelet study | Criteria Fulfill Allogeneic hematopoietic stem cell transplant
Item
13. donor must have infectious disease marker testing [hepatitis b, c, hiv, cmv, syphilis (rpr), chagas, htlv, and west nile virus] and cbc differential and platelet studies that meet standard medical eligibility criteria for allogeneic blood stem cell donation within 7 days of apheresis
boolean
C0013018 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0005516 (UMLS CUI [1,3])
C0039593 (UMLS CUI [1,4])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019693 (UMLS CUI [4])
C0010823 (UMLS CUI [5])
C0039128 (UMLS CUI [6])
C0201405 (UMLS CUI [7])
C0041234 (UMLS CUI [8])
C0086427 (UMLS CUI [9])
C0043125 (UMLS CUI [10])
C0545131 (UMLS CUI [11])
C2316857 (UMLS CUI [12])
C0243161 (UMLS CUI [13,1])
C1550543 (UMLS CUI [13,2])
C4255274 (UMLS CUI [13,3])
Donor Childbearing Potential Serum pregnancy test negative | Postmenopausal state | Female Sterilization | Apheresis
Item
14. donor, if a female of childbearing potential (non-childbearing is defined as greater than one year post-menopause or surgically sterilized), must have a negative serum test to rule out pregnancy within 14 days of apheresis
boolean
C0013018 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0430061 (UMLS CUI [1,3])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0005791 (UMLS CUI [4])
Donor Fulfill Criteria Allogeneic hematopoietic stem cell transplant
Item
15. donor must meet standard medical eligibility criteria for allogeneic stem cell donation
boolean
C0013018 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C4255274 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Relationships
Item
1. exclusion criteria applies to both the initiation of conditioning regimen and to the nk infusion
boolean
C0680251 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Central nervous system leukaemia
Item
2. active central nervous system (cns) leukemia
boolean
C1332884 (UMLS CUI [1])
Communicable Disease | Antimicrobial medicament | Fever
Item
3. active infection (defined as on antimicrobial therapy and or febrile)
boolean
C0009450 (UMLS CUI [1])
C0443071 (UMLS CUI [2])
C0015967 (UMLS CUI [3])
Breast Feeding
Item
4. breast-feeding females
boolean
C0006147 (UMLS CUI [1])
On ventilator | Oxygen supplementation Required
Item
5. currently using a ventilator or requiring supplemental oxygen
boolean
C2603364 (UMLS CUI [1])
C0919655 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Dialysis
Item
6. currently undergoing dialysis
boolean
C0011946 (UMLS CUI [1])
Investigational New Drugs To be stopped
Item
7. currently using a phase i, ii, or iii investigational agent. these agents should be stopped within 21 days of nk infusion
boolean
C0013230 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Cardiac Arrhythmia Uncontrolled
Item
8. new detected cardiac arrhythmia not controlled with medical management within prior 72 hour period.
boolean
C0003811 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Hypotension Requirement Pressor support
Item
9. hypotension requiring pressor support within prior 72 hour period
boolean
C0020649 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0281374 (UMLS CUI [1,3])
Communicable Disease Uncontrolled | Fever recurring daily Degrees Celsius | Culture positive Bacteria | Culture positive Fungi | Culture positive Virus | Indication Natural Killer Cells Infusion
Item
10. uncontrolled infection defined as daily fever greater than or equal to 38.2°c within prior 24 hours and new positive culture for bacteria, fungus, or virus within 72 hours prior to nk -cell infusion, if clinically indicated
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C2219980 (UMLS CUI [2,1])
C0439237 (UMLS CUI [2,2])
C0159125 (UMLS CUI [3,1])
C0004611 (UMLS CUI [3,2])
C0159125 (UMLS CUI [4,1])
C0016832 (UMLS CUI [4,2])
C0159125 (UMLS CUI [5,1])
C0042776 (UMLS CUI [5,2])
C3146298 (UMLS CUI [6,1])
C0022688 (UMLS CUI [6,2])
C0574032 (UMLS CUI [6,3])
Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intravenous
Item
11. taking corticosteroids by mouth or intravenously within prior 72 hour period
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
Ascites Requirement Paracentesis
Item
12. ascites requiring paracentesis within prior 72 hour period. (if the patient requires paracentesis within 72 hours of nk cell infusion, they will not be eligible to receive the infusion.)
boolean
C0003962 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0034115 (UMLS CUI [1,3])
Seizures | Encephalopathy | Neurologic Deficits Focal
Item
13. seizure activity or clinically detectable encephalopathy or new focal neurologic deficits within prior 72 hour period
boolean
C0036572 (UMLS CUI [1])
C0085584 (UMLS CUI [2])
C0521654 (UMLS CUI [3,1])
C0205234 (UMLS CUI [3,2])
Donor Communicable Disease | Antimicrobial medicament | Fever
Item
14. donor has active infection (defined as on antimicrobial therapy and/or febrile) within 7 days of apheresis
boolean
C0013018 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0443071 (UMLS CUI [2])
C0015967 (UMLS CUI [3])
Donor Pregnancy | Donor Breast Feeding
Item
15. donor is pregnant female or breast-feeding female (within 7 days of apheresis)
boolean
C0013018 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0013018 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])

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