Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute | Hemopoietic stem cell transplant Patient need for
Item
1. acute lymphoblastic leukemia (all) or acute myeloid leukemia (aml) requiring hsct
boolean
C0023449 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
C0472699 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Age
Item
2. age ≥ 1 and ≤ 16 years at screening
boolean
C0001779 (UMLS CUI [1])
Lansky Play-Performance Status
Item
3. lansky performance status > 60%
boolean
C1522275 (UMLS CUI [1])
Indication Allogeneic Hematopoietic Stem Cell Transplantation
Item
4. candidate for allogeneic hsct protocol:
boolean
C3146298 (UMLS CUI [1,1])
C1705576 (UMLS CUI [1,2])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Glomerular Filtration Rate Radioisotope
Item
adequate kidney function: serum creatinine: ≤ 1.5 mg/dl or creatinine clearance or radioisotope glomerular filtration rate (gfr) ≥ 60 ml/min/1.73m2
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C0017654 (UMLS CUI [4,1])
C0011916 (UMLS CUI [4,2])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Albumin measurement
Item
adequate liver function: serum total bilirubin: ≤ 2.0 mg/dl; aspartate transaminase (ast)/alanine aminotransferase (alt) ≤ 4.0 x institutional upper limits of normal (iuln); albumin ≥ 2 g/dl
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201838 (UMLS CUI [5])
Cardiac function | Shortening Fraction Echocardiography | Ejection fraction Multiple gated acquisition scanning
Item
adequate cardiac function: shortening fraction > 29% documented by echocardiogram, or ejection fraction ≥ 50% documented by multigated acquisition scan (muga).
boolean
C0232164 (UMLS CUI [1])
C1335957 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C0489482 (UMLS CUI [3,1])
C0521317 (UMLS CUI [3,2])
Pulmonary function Carbon Monoxide Diffusing Capability Test | Oxygen saturation measurement on room air | Pulmonary function tests
Item
adequate pulmonary function documented by corrected lung diffusion capacity test (dlco) > 50% or oxygen saturation of ≥ 92% on room air if unable to perform pulmonary function tests
boolean
C0231921 (UMLS CUI [1,1])
C1516251 (UMLS CUI [1,2])
C0523807 (UMLS CUI [2,1])
C2709070 (UMLS CUI [2,2])
C0024119 (UMLS CUI [3])
HIV negative | Hepatitis C virus Negative | Human t cell lymphotropic virus Negative
Item
negative for human immunodeficiency virus (hiv), hepatitis c virus (hcv), human t cell lymphotropic virus (htlv)
boolean
C0481430 (UMLS CUI [1])
C0220847 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0086427 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
Identification HLA Matching Donor
Item
5. identification of an hla-compatible donor per institutional standards
boolean
C0205396 (UMLS CUI [1,1])
C2348930 (UMLS CUI [1,2])
C0375877 (UMLS CUI [1,3])
Assent Minor
Item
6. assent from a minor (if the child is capable of giving assent) per department of health and human services (dhhs) guidelines listed in 21cfr 50.55 and local institutional review board (irb) standards.
boolean
C1879749 (UMLS CUI [1,1])
C0026193 (UMLS CUI [1,2])
Amylase measurement, serum | Serum lipase measurement
Item
7. serum amylase and lipase: ≤ 1.2 x iuln
boolean
C0201885 (UMLS CUI [1])
C0428316 (UMLS CUI [2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
8. negative serum/urine pregnancy test for females with childbearing potential within 4 days before administration of the first palifermin dose
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Reproductive potential Contraceptive methods
Item
9. agreement by males and females of reproductive potential to use an effective means of contraception 30 days prior to enrollment through day +30 (end of treatment)
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Palifermin | Keratinocyte growth factor
Item
1. prior treatment with palifermin or other keratinocyte growth factors
boolean
C0677829 (UMLS CUI [1])
C0064294 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Stem cell Separators Investigational
Item
2. received an investigational product or device, with the exception investigational stem cell separators, in another clinical trial within 30 days before enrollment.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C0038250 (UMLS CUI [4,1])
C0920434 (UMLS CUI [4,2])
C1517586 (UMLS CUI [4,3])
Life-threatening infections Poor response to treatment
Item
3. known to have a life threatening infection not responding well to treatment
boolean
C1859430 (UMLS CUI [1,1])
C1320680 (UMLS CUI [1,2])
Hepatic Veno-Occlusive Disease
Item
4. past history of veno-occlusive disease of the liver
boolean
C0019156 (UMLS CUI [1])
Hypersensitivity Product Escherichia coli Derived | Hypersensitivity Grade l-asparaginase
Item
5. known sensitivity to any escherichia coli-derived products with grade 3 to 4 allergies to l-asparaginase [grade 1 to 2 allergies to l-asparaginase will be allowed].
boolean
C0020517 (UMLS CUI [1,1])
C1514468 (UMLS CUI [1,2])
C0014834 (UMLS CUI [1,3])
C1441547 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C0003993 (UMLS CUI [2,3])
Glutamine | Pharmaceutical Preparations Reducing Oral Mucositis
Item
6. receiving glutamine or any other medication to reduce the incidence of oral mucositis (om) within 30 days before enrollment
boolean
C0017797 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0392756 (UMLS CUI [2,2])
C1568868 (UMLS CUI [2,3])
Malignant Neoplasms | Solid organ transplant | Therapeutic procedure Immunodeficiency congenital
Item
7. previous or concurrent malignancy other than entry diagnostic criteria and/or solid organ transplantation and/or treatment of congenital immunodeficiency
boolean
C0006826 (UMLS CUI [1])
C0730400 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0853602 (UMLS CUI [3,2])
Pancreatitis
Item
8. history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
Breast Feeding
Item
9. breastfeeding (giving)
boolean
C0006147 (UMLS CUI [1])