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])
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])