ID

30231

Description

Haploidentical Allogeneic Transplant w/Post Transplant Infusion of Regulatory T-cells (BMT Protocol 204); ODM derived from: https://clinicaltrials.gov/show/NCT01050764

Link

https://clinicaltrials.gov/show/NCT01050764

Keywords

Versions (1)
  1. 5/23/18 5/23/18 -
Copyright Holder

See clinicaltrials.gov

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May 23, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT01050764

English

Eligibility Leukemia NCT01050764

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01050764
Criteria
Description

Criteria

3.1.1 patients with the following diseases that are histopathologically confirmed are eligible:
Description

Patients eligible | Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [2]
C0012634
1. acute leukemia (in first remission with poor risk factors and molecular prognosis; aml with -5,-7, t(6;9), tri8, -11 and all with ph+ t(9;22), t(4;22), (q34;q11)
Description

Acute leukemia in remission Ordinal number | Risk factors Poor | Prognostic Marker Poor | AML Loss of Chromosome 5 | AML Loss of Chromosome 7 | Other Coding | AML Chromosome 8, trisomy | AML Loss of Chromosome 11 | Philadelphia chromosome-positive ALL t(9;22) | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0686586
UMLS CUI [1,2]
C0439080
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C0542537
UMLS CUI [3,1]
C1514475
UMLS CUI [3,2]
C0542537
UMLS CUI [4,1]
C0023467
UMLS CUI [4,2]
C1517985
UMLS CUI [5,1]
C0023467
UMLS CUI [5,2]
C1517989
UMLS CUI [6]
C3846158
UMLS CUI [7,1]
C0023467
UMLS CUI [7,2]
C0432412
UMLS CUI [8,1]
C0023467
UMLS CUI [8,2]
C1517950
UMLS CUI [9,1]
C1960397
UMLS CUI [9,2]
C3897138
UMLS CUI [10]
C3846158
2. acute leukemia with refractory disease or >cr1
Description

Acute leukemia Refractory Disease | Acute leukemia Complete remission Ordinal number

Data type

boolean

Alias
UMLS CUI [1,1]
C0085669
UMLS CUI [1,2]
C1514815
UMLS CUI [2,1]
C0085669
UMLS CUI [2,2]
C0677874
UMLS CUI [2,3]
C0439080
3. chronic myelogenous leukemia (accelerated, blast or second chronic phase)
Description

Leukemia, Myeloid, Accelerated Phase | Blast Phase | Leukemia, Myeloid, Chronic-Phase Ordinal number

Data type

boolean

Alias
UMLS CUI [1]
C0023472
UMLS CUI [2]
C0005699
UMLS CUI [3,1]
C0023474
UMLS CUI [3,2]
C0439080
4. myelodysplastic syndrome (in high and high intermediate risk categories)
Description

MYELODYSPLASTIC SYNDROME High risk | MYELODYSPLASTIC SYNDROME High risk Intermediate

Data type

boolean

Alias
UMLS CUI [1,1]
C3463824
UMLS CUI [1,2]
C0332167
UMLS CUI [2,1]
C3463824
UMLS CUI [2,2]
C0332167
UMLS CUI [2,3]
C0205103
5. non-hodgkin's lymphoma with poor risk features not suitable for autologous transplantation
Description

Non-Hodgkin Lymphoma Risk Poor | Non-Hodgkin Lymphoma Inappropriate Autologous Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0542537
UMLS CUI [2,1]
C0024305
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0040736
6. refractory cll
Description

CLL refractory

Data type

boolean

Alias
UMLS CUI [1]
C0278791
3.1.2 there are no limits on amount of prior therapy but there must be at least 21 days from the end of most recent prior therapy to start of transplant conditioning regimen.
Description

Prior Therapy Quantity Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0205197
3.1.3 the recipient must be <= 60 years old at time of registration.
Description

Recipient | Age

Data type

boolean

Alias
UMLS CUI [1]
C1709854
UMLS CUI [2]
C0001779
3.1.5 karnofsky performance status > 70%
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
3.1.6 the recipient must have a related donor genotypically hla-a, b,c and drb1, dq loci haploidentical to the recipient (but differing for 2-3 hla alleles on the unshared haplotype in the gvhd direction) and no hla matched sibling or matched unrelated donor is identified.
Description

Recipient | Donor Related HLA-A | Donor Related HLA-B | Donor Related HLA-C | DRB1 Haploidentical Recipient | DQ Haploidentical Recipient | Absence Sibling HLA Match | Absence Unrelated Donor Match

Data type

boolean

Alias
UMLS CUI [1]
C1709854
UMLS CUI [2,1]
C0013018
UMLS CUI [2,2]
C0080103
UMLS CUI [2,3]
C0019728
UMLS CUI [3,1]
C0013018
UMLS CUI [3,2]
C0080103
UMLS CUI [3,3]
C0019737
UMLS CUI [4,1]
C0013018
UMLS CUI [4,2]
C0080103
UMLS CUI [4,3]
C0019751
UMLS CUI [5,1]
C1837204
UMLS CUI [5,2]
C3829897
UMLS CUI [5,3]
C1709854
UMLS CUI [6,1]
C0019761
UMLS CUI [6,2]
C3829897
UMLS CUI [6,3]
C1709854
UMLS CUI [7,1]
C0332197
UMLS CUI [7,2]
C0037047
UMLS CUI [7,3]
C0019721
UMLS CUI [7,4]
C1708943
UMLS CUI [8,1]
C0332197
UMLS CUI [8,2]
C3179133
UMLS CUI [8,3]
C1708943
3.1.7 adequate cardiac and pulmonary function (lvef > 45%, dlco >50% corrected for hemoglobin)
Description

Cardiac function | Pulmonary function | Left ventricular ejection fraction | Hemoglobin Corrected DLCO

Data type

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0231921
UMLS CUI [3]
C0428772
UMLS CUI [4]
C4054790
3.1.8 serum creatinine <1.5 mg/dl or creatinine clearance >50 ml/min for those above serum creatinine of 1.5; serum bilirubin <2.0 mg/dl; alt <2x uln (unless secondary to disease)
Description

Creatinine measurement, serum | Creatinine clearance measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Exception Secondary to Disease

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201836
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0175668
UMLS CUI [5,3]
C0012634
3.1.9 no prior myeloablative therapy or hematopoeitic cell transplantation
Description

Bone Marrow Purging Absent | Hemopoietic stem cell transplant Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0085079
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0472699
UMLS CUI [2,2]
C0332197
donor inclusion criteria
Description

Donor Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C1512693
3.3.1 age < 70 years and weight > 25 kg. 3.3.2 medical history and physical examination confirm good health status as defined by institutional standards 3.3.3 seronegative for hiv ag, hepatitis b sag or pcr+ or hepatitis c ab or pcr+ within 30 days of apheresis collection 3.3.4 genotypically haploidentical as determined by hla typing 3.3.5 female donors of child-bearing potential must have a negative serum or urine beta-hcg test within three weeks of mobilization 3.3.6 capable of undergoing leukapheresis, have adequate venous access, and be willing to undergo insertion of a central catheter should leukapheresis via peripheral vein be inadequate 3.3.7 capable of agreeing to second donation of pbpc (or a bone marrow harvest) should the patient fail to demonstrate sustained engraftment following the transplant 3.3.8 the donor or legal guardian greater than 18 years of age, capable of signing an irb-approved consent form.
Description

Age | Body Weight | Overall Well Being | HIV antigen test Seronegative | Hepatitis B Surface Antigens Seronegative | Hepatitis B Surface Antigens Polymerase chain reaction positive | Hepatitis C Antibodies Seronegative | Hepatitis C Antibodies Polymerase chain reaction positive | Apheresis | Haploidentical HLA Typing | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test Negative | Capability Leukapheresis | Venous access patent | Catheterization Willing | Peripheral Stem Cell Transplantation Ordinal number | Aspiration of bone marrow from donor for transplant | Informed Consent Donor | Informed Consent Legal Guardians

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0005910
UMLS CUI [3]
C3813622
UMLS CUI [4,1]
C0201385
UMLS CUI [4,2]
C0521144
UMLS CUI [5,1]
C0019168
UMLS CUI [5,2]
C0521144
UMLS CUI [6,1]
C0019168
UMLS CUI [6,2]
C3888499
UMLS CUI [7,1]
C0166049
UMLS CUI [7,2]
C0521144
UMLS CUI [8,1]
C0166049
UMLS CUI [8,2]
C3888499
UMLS CUI [9]
C0005791
UMLS CUI [10,1]
C3829897
UMLS CUI [10,2]
C0242318
UMLS CUI [11,1]
C3831118
UMLS CUI [11,2]
C0430061
UMLS CUI [12,1]
C3831118
UMLS CUI [12,2]
C0430056
UMLS CUI [12,3]
C1513916
UMLS CUI [13,1]
C2698977
UMLS CUI [13,2]
C0023416
UMLS CUI [14]
C3164222
UMLS CUI [15,1]
C0007430
UMLS CUI [15,2]
C0600109
UMLS CUI [16,1]
C0242602
UMLS CUI [16,2]
C0439080
UMLS CUI [17]
C0194015
UMLS CUI [18,1]
C0021430
UMLS CUI [18,2]
C0013018
UMLS CUI [19,1]
C0021430
UMLS CUI [19,2]
C0023226
3.3.9 donor selection
Description

Donor Selection

Data type

boolean

Alias
UMLS CUI [1]
C1449559
the order of donor section will be as follows:
Description

Order Donor Selection

Data type

boolean

Alias
UMLS CUI [1,1]
C1705176
UMLS CUI [1,2]
C1449559
1. if available, the recipient's biological mother will be the preferential donor
Description

Natural mother Recipient | Donor preferred

Data type

boolean

Alias
UMLS CUI [1,1]
C0337486
UMLS CUI [1,2]
C1709854
UMLS CUI [2,1]
C0013018
UMLS CUI [2,2]
C0558295
2. if the biological mother is not available, then other available haploidentical donors will be selected based upon the presence of nk alloreactivity between donor and recipient. the donor will be selected based on the presence of nk alloreactivity as determined by high-resolution hla typing of the c locus of both donor and recipient. recipients lacking a kir-ligand present in the donor along with the corresponding kir defines "nk alloreactivity". an nk alloreactive donor will be preferentially chosen.
Description

Donor Haploidentical | Natural Killer Cells Reactivity Allograft | HLA-C locus HLA Typing High resolution

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C3829897
UMLS CUI [2,1]
C0022688
UMLS CUI [2,2]
C0443286
UMLS CUI [2,3]
C0040739
UMLS CUI [3,1]
C0019751
UMLS CUI [3,2]
C0242318
UMLS CUI [3,3]
C1719039
3. if more than 1 nk alloreactive donor is available, then preference will be to use an nk alloreactive donor that is cmv seronegative.
Description

Donor | Natural Killer Cells Reactivity Allograft | Cytomegalovirus Seronegative

Data type

boolean

Alias
UMLS CUI [1]
C0013018
UMLS CUI [2,1]
C0022688
UMLS CUI [2,2]
C0443286
UMLS CUI [2,3]
C0040739
UMLS CUI [3,1]
C0010825
UMLS CUI [3,2]
C0521144
exclusion criteria:recipient exclusion criteria
Description

Exclusion Criteria Recipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1709854
3.2.1 the recipient is a suitable candidate for autologous transplantation or allogeneic transplantation with an available matched related or unrelated donor.
Description

Recipient Appropriate Autologous Transplantation | Recipient Appropriate Homologous Transplantation | Availability of Donor Related Match | Availability of Unrelated Donor Match

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0040736
UMLS CUI [2,1]
C1709854
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0040739
UMLS CUI [3,1]
C0470187
UMLS CUI [3,2]
C0013018
UMLS CUI [3,3]
C0080103
UMLS CUI [3,4]
C1708943
UMLS CUI [4,1]
C0470187
UMLS CUI [4,2]
C3179133
UMLS CUI [4,3]
C1708943
3.2.2 seropositive for any of the following: hiv ab, hepatitis b sag or pcr+ or hepatitis c ab or pcr+ 3.2.3 history of invasive aspergillosis; presence of any other active, uncontrolled bacterial, viral or fungal infection 3.2.4 uncontrolled cns disease involvement 3.2.7 the recipient is a lactating female
Description

HIV Seropositivity | Hepatitis B Surface Antigens Seropositive | Hepatitis B Surface Antigens Polymerase chain reaction positive | Hepatitis C Antibodies Seropositive | Hepatitis C Antibodies Polymerase chain reaction positive | Invasive aspergillosis | Bacterial Infection Uncontrolled | Virus Disease Uncontrolled | Mycoses Uncontrolled | CNS disorder Involvement Uncontrolled | Recipient Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0521143
UMLS CUI [3,1]
C0019168
UMLS CUI [3,2]
C3888499
UMLS CUI [4,1]
C0166049
UMLS CUI [4,2]
C0521143
UMLS CUI [5,1]
C0166049
UMLS CUI [5,2]
C3888499
UMLS CUI [6]
C0238013
UMLS CUI [7,1]
C0004623
UMLS CUI [7,2]
C0205318
UMLS CUI [8,1]
C0042769
UMLS CUI [8,2]
C0205318
UMLS CUI [9,1]
C0026946
UMLS CUI [9,2]
C0205318
UMLS CUI [10,1]
C0007682
UMLS CUI [10,2]
C1314939
UMLS CUI [10,3]
C0205318
UMLS CUI [11,1]
C1709854
UMLS CUI [11,2]
C0006147
3.4 donor exclusion criteria 3.4.1 evidence of active infection or viral hepatitis 3.4.3 factors which place the donor at increased risk for complications from leukapheresis or g-csf therapy 3.4.4 lactating female 3.4.5 hiv positive
Description

Donor Exclusion Criteria | Communicable Disease | Viral hepatitis | At risk Leukapheresis Complication | At risk G-CSF therapy Complication | Breast Feeding | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0680251
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0042721
UMLS CUI [4,1]
C1444641
UMLS CUI [4,2]
C0023416
UMLS CUI [4,3]
C0009566
UMLS CUI [5,1]
C1444641
UMLS CUI [5,2]
C0860380
UMLS CUI [5,3]
C0009566
UMLS CUI [6]
C0006147
UMLS CUI [7]
C0019699
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Similar models

Eligibility Leukemia NCT01050764

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01050764
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patients eligible | Disease
Item
3.1.1 patients with the following diseases that are histopathologically confirmed are eligible:
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2])
Acute leukemia in remission Ordinal number | Risk factors Poor | Prognostic Marker Poor | AML Loss of Chromosome 5 | AML Loss of Chromosome 7 | Other Coding | AML Chromosome 8, trisomy | AML Loss of Chromosome 11 | Philadelphia chromosome-positive ALL t(9;22) | Other Coding
Item
1. acute leukemia (in first remission with poor risk factors and molecular prognosis; aml with -5,-7, t(6;9), tri8, -11 and all with ph+ t(9;22), t(4;22), (q34;q11)
boolean
C0686586 (UMLS CUI [1,1])
C0439080 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0542537 (UMLS CUI [2,2])
C1514475 (UMLS CUI [3,1])
C0542537 (UMLS CUI [3,2])
C0023467 (UMLS CUI [4,1])
C1517985 (UMLS CUI [4,2])
C0023467 (UMLS CUI [5,1])
C1517989 (UMLS CUI [5,2])
C3846158 (UMLS CUI [6])
C0023467 (UMLS CUI [7,1])
C0432412 (UMLS CUI [7,2])
C0023467 (UMLS CUI [8,1])
C1517950 (UMLS CUI [8,2])
C1960397 (UMLS CUI [9,1])
C3897138 (UMLS CUI [9,2])
C3846158 (UMLS CUI [10])
Acute leukemia Refractory Disease | Acute leukemia Complete remission Ordinal number
Item
2. acute leukemia with refractory disease or >cr1
boolean
C0085669 (UMLS CUI [1,1])
C1514815 (UMLS CUI [1,2])
C0085669 (UMLS CUI [2,1])
C0677874 (UMLS CUI [2,2])
C0439080 (UMLS CUI [2,3])
Leukemia, Myeloid, Accelerated Phase | Blast Phase | Leukemia, Myeloid, Chronic-Phase Ordinal number
Item
3. chronic myelogenous leukemia (accelerated, blast or second chronic phase)
boolean
C0023472 (UMLS CUI [1])
C0005699 (UMLS CUI [2])
C0023474 (UMLS CUI [3,1])
C0439080 (UMLS CUI [3,2])
MYELODYSPLASTIC SYNDROME High risk | MYELODYSPLASTIC SYNDROME High risk Intermediate
Item
4. myelodysplastic syndrome (in high and high intermediate risk categories)
boolean
C3463824 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C3463824 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C0205103 (UMLS CUI [2,3])
Non-Hodgkin Lymphoma Risk Poor | Non-Hodgkin Lymphoma Inappropriate Autologous Transplantation
Item
5. non-hodgkin's lymphoma with poor risk features not suitable for autologous transplantation
boolean
C0024305 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0542537 (UMLS CUI [1,3])
C0024305 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0040736 (UMLS CUI [2,3])
CLL refractory
Item
6. refractory cll
boolean
C0278791 (UMLS CUI [1])
Prior Therapy Quantity Completed
Item
3.1.2 there are no limits on amount of prior therapy but there must be at least 21 days from the end of most recent prior therapy to start of transplant conditioning regimen.
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Recipient | Age
Item
3.1.3 the recipient must be <= 60 years old at time of registration.
boolean
C1709854 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Karnofsky Performance Status
Item
3.1.5 karnofsky performance status > 70%
boolean
C0206065 (UMLS CUI [1])
Recipient | Donor Related HLA-A | Donor Related HLA-B | Donor Related HLA-C | DRB1 Haploidentical Recipient | DQ Haploidentical Recipient | Absence Sibling HLA Match | Absence Unrelated Donor Match
Item
3.1.6 the recipient must have a related donor genotypically hla-a, b,c and drb1, dq loci haploidentical to the recipient (but differing for 2-3 hla alleles on the unshared haplotype in the gvhd direction) and no hla matched sibling or matched unrelated donor is identified.
boolean
C1709854 (UMLS CUI [1])
C0013018 (UMLS CUI [2,1])
C0080103 (UMLS CUI [2,2])
C0019728 (UMLS CUI [2,3])
C0013018 (UMLS CUI [3,1])
C0080103 (UMLS CUI [3,2])
C0019737 (UMLS CUI [3,3])
C0013018 (UMLS CUI [4,1])
C0080103 (UMLS CUI [4,2])
C0019751 (UMLS CUI [4,3])
C1837204 (UMLS CUI [5,1])
C3829897 (UMLS CUI [5,2])
C1709854 (UMLS CUI [5,3])
C0019761 (UMLS CUI [6,1])
C3829897 (UMLS CUI [6,2])
C1709854 (UMLS CUI [6,3])
C0332197 (UMLS CUI [7,1])
C0037047 (UMLS CUI [7,2])
C0019721 (UMLS CUI [7,3])
C1708943 (UMLS CUI [7,4])
C0332197 (UMLS CUI [8,1])
C3179133 (UMLS CUI [8,2])
C1708943 (UMLS CUI [8,3])
Cardiac function | Pulmonary function | Left ventricular ejection fraction | Hemoglobin Corrected DLCO
Item
3.1.7 adequate cardiac and pulmonary function (lvef > 45%, dlco >50% corrected for hemoglobin)
boolean
C0232164 (UMLS CUI [1])
C0231921 (UMLS CUI [2])
C0428772 (UMLS CUI [3])
C4054790 (UMLS CUI [4])
Creatinine measurement, serum | Creatinine clearance measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Exception Secondary to Disease
Item
3.1.8 serum creatinine <1.5 mg/dl or creatinine clearance >50 ml/min for those above serum creatinine of 1.5; serum bilirubin <2.0 mg/dl; alt <2x uln (unless secondary to disease)
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0175668 (UMLS CUI [5,2])
C0012634 (UMLS CUI [5,3])
Bone Marrow Purging Absent | Hemopoietic stem cell transplant Absent
Item
3.1.9 no prior myeloablative therapy or hematopoeitic cell transplantation
boolean
C0085079 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0472699 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Donor Inclusion criteria
Item
donor inclusion criteria
boolean
C0013018 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Age | Body Weight | Overall Well Being | HIV antigen test Seronegative | Hepatitis B Surface Antigens Seronegative | Hepatitis B Surface Antigens Polymerase chain reaction positive | Hepatitis C Antibodies Seronegative | Hepatitis C Antibodies Polymerase chain reaction positive | Apheresis | Haploidentical HLA Typing | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test Negative | Capability Leukapheresis | Venous access patent | Catheterization Willing | Peripheral Stem Cell Transplantation Ordinal number | Aspiration of bone marrow from donor for transplant | Informed Consent Donor | Informed Consent Legal Guardians
Item
3.3.1 age < 70 years and weight > 25 kg. 3.3.2 medical history and physical examination confirm good health status as defined by institutional standards 3.3.3 seronegative for hiv ag, hepatitis b sag or pcr+ or hepatitis c ab or pcr+ within 30 days of apheresis collection 3.3.4 genotypically haploidentical as determined by hla typing 3.3.5 female donors of child-bearing potential must have a negative serum or urine beta-hcg test within three weeks of mobilization 3.3.6 capable of undergoing leukapheresis, have adequate venous access, and be willing to undergo insertion of a central catheter should leukapheresis via peripheral vein be inadequate 3.3.7 capable of agreeing to second donation of pbpc (or a bone marrow harvest) should the patient fail to demonstrate sustained engraftment following the transplant 3.3.8 the donor or legal guardian greater than 18 years of age, capable of signing an irb-approved consent form.
boolean
C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
C3813622 (UMLS CUI [3])
C0201385 (UMLS CUI [4,1])
C0521144 (UMLS CUI [4,2])
C0019168 (UMLS CUI [5,1])
C0521144 (UMLS CUI [5,2])
C0019168 (UMLS CUI [6,1])
C3888499 (UMLS CUI [6,2])
C0166049 (UMLS CUI [7,1])
C0521144 (UMLS CUI [7,2])
C0166049 (UMLS CUI [8,1])
C3888499 (UMLS CUI [8,2])
C0005791 (UMLS CUI [9])
C3829897 (UMLS CUI [10,1])
C0242318 (UMLS CUI [10,2])
C3831118 (UMLS CUI [11,1])
C0430061 (UMLS CUI [11,2])
C3831118 (UMLS CUI [12,1])
C0430056 (UMLS CUI [12,2])
C1513916 (UMLS CUI [12,3])
C2698977 (UMLS CUI [13,1])
C0023416 (UMLS CUI [13,2])
C3164222 (UMLS CUI [14])
C0007430 (UMLS CUI [15,1])
C0600109 (UMLS CUI [15,2])
C0242602 (UMLS CUI [16,1])
C0439080 (UMLS CUI [16,2])
C0194015 (UMLS CUI [17])
C0021430 (UMLS CUI [18,1])
C0013018 (UMLS CUI [18,2])
C0021430 (UMLS CUI [19,1])
C0023226 (UMLS CUI [19,2])
Donor Selection
Item
3.3.9 donor selection
boolean
C1449559 (UMLS CUI [1])
Order Donor Selection
Item
the order of donor section will be as follows:
boolean
C1705176 (UMLS CUI [1,1])
C1449559 (UMLS CUI [1,2])
Natural mother Recipient | Donor preferred
Item
1. if available, the recipient's biological mother will be the preferential donor
boolean
C0337486 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C0013018 (UMLS CUI [2,1])
C0558295 (UMLS CUI [2,2])
Donor Haploidentical | Natural Killer Cells Reactivity Allograft | HLA-C locus HLA Typing High resolution
Item
2. if the biological mother is not available, then other available haploidentical donors will be selected based upon the presence of nk alloreactivity between donor and recipient. the donor will be selected based on the presence of nk alloreactivity as determined by high-resolution hla typing of the c locus of both donor and recipient. recipients lacking a kir-ligand present in the donor along with the corresponding kir defines "nk alloreactivity". an nk alloreactive donor will be preferentially chosen.
boolean
C0013018 (UMLS CUI [1,1])
C3829897 (UMLS CUI [1,2])
C0022688 (UMLS CUI [2,1])
C0443286 (UMLS CUI [2,2])
C0040739 (UMLS CUI [2,3])
C0019751 (UMLS CUI [3,1])
C0242318 (UMLS CUI [3,2])
C1719039 (UMLS CUI [3,3])
Donor | Natural Killer Cells Reactivity Allograft | Cytomegalovirus Seronegative
Item
3. if more than 1 nk alloreactive donor is available, then preference will be to use an nk alloreactive donor that is cmv seronegative.
boolean
C0013018 (UMLS CUI [1])
C0022688 (UMLS CUI [2,1])
C0443286 (UMLS CUI [2,2])
C0040739 (UMLS CUI [2,3])
C0010825 (UMLS CUI [3,1])
C0521144 (UMLS CUI [3,2])
Exclusion Criteria Recipient
Item
exclusion criteria:recipient exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
Recipient Appropriate Autologous Transplantation | Recipient Appropriate Homologous Transplantation | Availability of Donor Related Match | Availability of Unrelated Donor Match
Item
3.2.1 the recipient is a suitable candidate for autologous transplantation or allogeneic transplantation with an available matched related or unrelated donor.
boolean
C1709854 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0040736 (UMLS CUI [1,3])
C1709854 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0040739 (UMLS CUI [2,3])
C0470187 (UMLS CUI [3,1])
C0013018 (UMLS CUI [3,2])
C0080103 (UMLS CUI [3,3])
C1708943 (UMLS CUI [3,4])
C0470187 (UMLS CUI [4,1])
C3179133 (UMLS CUI [4,2])
C1708943 (UMLS CUI [4,3])
HIV Seropositivity | Hepatitis B Surface Antigens Seropositive | Hepatitis B Surface Antigens Polymerase chain reaction positive | Hepatitis C Antibodies Seropositive | Hepatitis C Antibodies Polymerase chain reaction positive | Invasive aspergillosis | Bacterial Infection Uncontrolled | Virus Disease Uncontrolled | Mycoses Uncontrolled | CNS disorder Involvement Uncontrolled | Recipient Breast Feeding
Item
3.2.2 seropositive for any of the following: hiv ab, hepatitis b sag or pcr+ or hepatitis c ab or pcr+ 3.2.3 history of invasive aspergillosis; presence of any other active, uncontrolled bacterial, viral or fungal infection 3.2.4 uncontrolled cns disease involvement 3.2.7 the recipient is a lactating female
boolean
C0019699 (UMLS CUI [1])
C0019168 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0019168 (UMLS CUI [3,1])
C3888499 (UMLS CUI [3,2])
C0166049 (UMLS CUI [4,1])
C0521143 (UMLS CUI [4,2])
C0166049 (UMLS CUI [5,1])
C3888499 (UMLS CUI [5,2])
C0238013 (UMLS CUI [6])
C0004623 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0042769 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
C0026946 (UMLS CUI [9,1])
C0205318 (UMLS CUI [9,2])
C0007682 (UMLS CUI [10,1])
C1314939 (UMLS CUI [10,2])
C0205318 (UMLS CUI [10,3])
C1709854 (UMLS CUI [11,1])
C0006147 (UMLS CUI [11,2])
Donor Exclusion Criteria | Communicable Disease | Viral hepatitis | At risk Leukapheresis Complication | At risk G-CSF therapy Complication | Breast Feeding | HIV Seropositivity
Item
3.4 donor exclusion criteria 3.4.1 evidence of active infection or viral hepatitis 3.4.3 factors which place the donor at increased risk for complications from leukapheresis or g-csf therapy 3.4.4 lactating female 3.4.5 hiv positive
boolean
C0013018 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0042721 (UMLS CUI [3])
C1444641 (UMLS CUI [4,1])
C0023416 (UMLS CUI [4,2])
C0009566 (UMLS CUI [4,3])
C1444641 (UMLS CUI [5,1])
C0860380 (UMLS CUI [5,2])
C0009566 (UMLS CUI [5,3])
C0006147 (UMLS CUI [6])
C0019699 (UMLS CUI [7])
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