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])