ID

21410

Description

A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT; ODM derived from: https://clinicaltrials.gov/show/NCT00460421

Link

https://clinicaltrials.gov/show/NCT00460421

Keywords

Versions (1)
  1. 4/19/17 4/19/17 -
Uploaded on

April 19, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00460421

English

Eligibility Leukemia NCT00460421

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00460421
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. acute lymphoblastic leukemia (all) or acute myeloid leukemia (aml) requiring hsct
Description

Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute | Hemopoietic stem cell transplant Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0023467
UMLS CUI [3,1]
C0472699
UMLS CUI [3,2]
C0686904
2. age ≥ 1 and ≤ 16 years at screening
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. lansky performance status > 60%
Description

Lansky Play-Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1522275
4. candidate for allogeneic hsct protocol:
Description

Indication Allogeneic Hematopoietic Stem Cell Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1705576
adequate kidney function: serum creatinine: ≤ 1.5 mg/dl or creatinine clearance or radioisotope glomerular filtration rate (gfr) ≥ 60 ml/min/1.73m2
Description

Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Glomerular Filtration Rate Radioisotope

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
UMLS CUI [4,1]
C0017654
UMLS CUI [4,2]
C0011916
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
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Albumin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201838
adequate cardiac function: shortening fraction > 29% documented by echocardiogram, or ejection fraction ≥ 50% documented by multigated acquisition scan (muga).
Description

Cardiac function | Shortening Fraction Echocardiography | Ejection fraction Multiple gated acquisition scanning

Data type

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2,1]
C1335957
UMLS CUI [2,2]
C0013516
UMLS CUI [3,1]
C0489482
UMLS CUI [3,2]
C0521317
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
Description

Pulmonary function Carbon Monoxide Diffusing Capability Test | Oxygen saturation measurement on room air | Pulmonary function tests

Data type

boolean

Alias
UMLS CUI [1,1]
C0231921
UMLS CUI [1,2]
C1516251
UMLS CUI [2,1]
C0523807
UMLS CUI [2,2]
C2709070
UMLS CUI [3]
C0024119
negative for human immunodeficiency virus (hiv), hepatitis c virus (hcv), human t cell lymphotropic virus (htlv)
Description

HIV negative | Hepatitis C virus Negative | Human t cell lymphotropic virus Negative

Data type

boolean

Alias
UMLS CUI [1]
C0481430
UMLS CUI [2,1]
C0220847
UMLS CUI [2,2]
C1513916
UMLS CUI [3,1]
C0086427
UMLS CUI [3,2]
C1513916
5. identification of an hla-compatible donor per institutional standards
Description

Identification HLA Matching Donor

Data type

boolean

Alias
UMLS CUI [1,1]
C0205396
UMLS CUI [1,2]
C2348930
UMLS CUI [1,3]
C0375877
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.
Description

Assent Minor

Data type

boolean

Alias
UMLS CUI [1,1]
C1879749
UMLS CUI [1,2]
C0026193
7. serum amylase and lipase: ≤ 1.2 x iuln
Description

Amylase measurement, serum | Serum lipase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201885
UMLS CUI [2]
C0428316
8. negative serum/urine pregnancy test for females with childbearing potential within 4 days before administration of the first palifermin dose
Description

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
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)
Description

Reproductive potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior treatment with palifermin or other keratinocyte growth factors
Description

Palifermin | Keratinocyte growth factor

Data type

boolean

Alias
UMLS CUI [1]
C0677829
UMLS CUI [2]
C0064294
2. received an investigational product or device, with the exception investigational stem cell separators, in another clinical trial within 30 days before enrollment.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Stem cell Separators Investigational

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4,1]
C0038250
UMLS CUI [4,2]
C0920434
UMLS CUI [4,3]
C1517586
3. known to have a life threatening infection not responding well to treatment
Description

Life-threatening infections Poor response to treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1859430
UMLS CUI [1,2]
C1320680
4. past history of veno-occlusive disease of the liver
Description

Hepatic Veno-Occlusive Disease

Data type

boolean

Alias
UMLS CUI [1]
C0019156
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].
Description

Hypersensitivity Product Escherichia coli Derived | Hypersensitivity Grade l-asparaginase

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1514468
UMLS CUI [1,3]
C0014834
UMLS CUI [1,4]
C1441547
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0441800
UMLS CUI [2,3]
C0003993
6. receiving glutamine or any other medication to reduce the incidence of oral mucositis (om) within 30 days before enrollment
Description

Glutamine | Pharmaceutical Preparations Reducing Oral Mucositis

Data type

boolean

Alias
UMLS CUI [1]
C0017797
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392756
UMLS CUI [2,3]
C1568868
7. previous or concurrent malignancy other than entry diagnostic criteria and/or solid organ transplantation and/or treatment of congenital immunodeficiency
Description

Malignant Neoplasms | Solid organ transplant | Therapeutic procedure Immunodeficiency congenital

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0730400
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0853602
8. history of pancreatitis
Description

Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305
9. breastfeeding (giving)
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Leukemia NCT00460421

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00460421
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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