ID

21958

Beskrivning

Cellular Therapy With Cord Blood Cells; ODM derived from: https://clinicaltrials.gov/show/NCT00427557

Länk

https://clinicaltrials.gov/show/NCT00427557

Nyckelord

Versioner (1)
  1. 2017-05-09 2017-05-09 -
Uppladdad den

9 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00427557

Engelsk

Eligibility Multiple Myeloma NCT00427557

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with multiple myeloma (mm), acute myeloid leukemia (aml), myelodysplastic syndrome (mds), acute lymphoblastic leukemia (all), non-hodgkin's lymphoma (nhl), hodgkin's lymphoma (hl), or chronic lymphocytic leukemia (cll) in greater than first complete remission who are candidates for a non-ablative or reduced intensity conditioning regimen.
Beskrivning

Multiple Myeloma | Leukemia, Myelocytic, Acute | MYELODYSPLASTIC SYNDROME | Acute lymphocytic leukemia | Lymphoma, Non-Hodgkin | Hodgkin Disease | Chronic Lymphocytic Leukemia | In complete remission | Therapeutic procedure Without Ablation | Therapeutic procedure With intensity Reduced

Datatyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0023467
UMLS CUI [3]
C3463824
UMLS CUI [4]
C0023449
UMLS CUI [5]
C0024305
UMLS CUI [6]
C0019829
UMLS CUI [7]
C0023434
UMLS CUI [8]
C0677874
UMLS CUI [9,1]
C0087111
UMLS CUI [9,2]
C0332288
UMLS CUI [9,3]
C0547070
UMLS CUI [10,1]
C0087111
UMLS CUI [10,2]
C0522510
UMLS CUI [10,3]
C0392756
2. age up to 80 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. a related or unrelated donor who is hla-matched at hla, a, b, c, dr and dq loci is acceptable (i.e. 10/10 matched related or unrelated donor, matched with molecular high-resolution technique per current standard for the bmt program). donor must be willing to donate peripheral blood or bone marrow progenitor cells.
Beskrivning

Donor Relative | Unrelated Donors | Histocompatibility crossmatch | HLA-A Antigens | HLA-B Antigens | HLA-C Antigens | HLA-DR locus | HLA-DQ Antigens | Peripheral blood stem cell | Bone marrow stem cell

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0080103
UMLS CUI [2]
C3179133
UMLS CUI [3]
C0549171
UMLS CUI [4]
C0019728
UMLS CUI [5]
C0019737
UMLS CUI [6]
C0019751
UMLS CUI [7]
C0221128
UMLS CUI [8]
C0019761
UMLS CUI [9]
C1518999
UMLS CUI [10]
C1511246
4. available cord blood unit must contain a minimum of 1.5 * 10^7 total nucleated cells per kg, and be at least a 4/6 hla match with patient.
Beskrivning

Umbilical Cord Blood Unit Available | Nucleated cell Quantity | Histocompatibility crossmatch

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162371
UMLS CUI [1,2]
C0439148
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C1180059
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0549171
5. zubrod ps less than or equal to 2 or lansky ps greater than or equal to 50%.
Beskrivning

Zubrod Performance Status | Lansky Play-Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C3714786
UMLS CUI [2]
C1522275
6. left ventricular ejection fraction >40%. no uncontrolled arrhythmias or symptomatic heart disease.
Beskrivning

Left ventricular ejection fraction | Cardiac Arrhythmia Uncontrolled Absent | Heart Disease Symptomatic Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0231220
UMLS CUI [3,3]
C0332197
7. forced expiratory volume in 1 second (fev1), forced vital capacity (fvc) and diffusion capacity (dlco) >40%.
Beskrivning

FEV1 | Forced vital capacity | Carbon Monoxide Diffusing Capability Test

Datatyp

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C1287681
UMLS CUI [3]
C1516251
8. serum creatinine <2.0 mg/dl. serum bilirubin <3 * upper limit of normal, sgpt <4 *
Beskrivning

Creatinine measurement, serum | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
upper limit of normal.
Beskrivning

Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with active cns disease
Beskrivning

CNS disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0007682
2. positive beta hcg in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
Beskrivning

Childbearing Potential Beta HCG positive | Postmenopausal state Absent | Female Sterilization Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0813152
UMLS CUI [2,1]
C0232970
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0015787
UMLS CUI [3,2]
C0332197
3. serious medical or psychiatric illness likely to interfere with participation in this clinical study, including but not limited to active uncontrolled infection, uncontrolled cardiac arrhythmia or ischemic event, or uncontrolled psychosis, major depression, or mania.
Beskrivning

Illness Serious Interferes with Study Subject Participation Status | Mental disorder Serious Interferes with Study Subject Participation Status | Communicable Disease Uncontrolled | Cardiac Arrhythmia Uncontrolled | Event Ischemic | Psychotic Disorder Uncontrolled | Major Depressive Disorder | Manic Disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C2348568
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0441471
UMLS CUI [5,2]
C0475224
UMLS CUI [6,1]
C0033975
UMLS CUI [6,2]
C0205318
UMLS CUI [7]
C1269683
UMLS CUI [8]
C0024713
4. evidence of chronic, active hepatitis or cirrhosis, or hiv
Beskrivning

Chronic Hepatitis Evidence of | Liver Cirrhosis Evidence of | HIV Infection Evidence of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019189
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0332120
UMLS CUI [3,1]
C0019693
UMLS CUI [3,2]
C0332120
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Similar models

Eligibility Multiple Myeloma NCT00427557

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Leukemia, Myelocytic, Acute | MYELODYSPLASTIC SYNDROME | Acute lymphocytic leukemia | Lymphoma, Non-Hodgkin | Hodgkin Disease | Chronic Lymphocytic Leukemia | In complete remission | Therapeutic procedure Without Ablation | Therapeutic procedure With intensity Reduced
Item
1. patients with multiple myeloma (mm), acute myeloid leukemia (aml), myelodysplastic syndrome (mds), acute lymphoblastic leukemia (all), non-hodgkin's lymphoma (nhl), hodgkin's lymphoma (hl), or chronic lymphocytic leukemia (cll) in greater than first complete remission who are candidates for a non-ablative or reduced intensity conditioning regimen.
boolean
C0026764 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
C3463824 (UMLS CUI [3])
C0023449 (UMLS CUI [4])
C0024305 (UMLS CUI [5])
C0019829 (UMLS CUI [6])
C0023434 (UMLS CUI [7])
C0677874 (UMLS CUI [8])
C0087111 (UMLS CUI [9,1])
C0332288 (UMLS CUI [9,2])
C0547070 (UMLS CUI [9,3])
C0087111 (UMLS CUI [10,1])
C0522510 (UMLS CUI [10,2])
C0392756 (UMLS CUI [10,3])
Age
Item
2. age up to 80 years.
boolean
C0001779 (UMLS CUI [1])
Donor Relative | Unrelated Donors | Histocompatibility crossmatch | HLA-A Antigens | HLA-B Antigens | HLA-C Antigens | HLA-DR locus | HLA-DQ Antigens | Peripheral blood stem cell | Bone marrow stem cell
Item
3. a related or unrelated donor who is hla-matched at hla, a, b, c, dr and dq loci is acceptable (i.e. 10/10 matched related or unrelated donor, matched with molecular high-resolution technique per current standard for the bmt program). donor must be willing to donate peripheral blood or bone marrow progenitor cells.
boolean
C0013018 (UMLS CUI [1,1])
C0080103 (UMLS CUI [1,2])
C3179133 (UMLS CUI [2])
C0549171 (UMLS CUI [3])
C0019728 (UMLS CUI [4])
C0019737 (UMLS CUI [5])
C0019751 (UMLS CUI [6])
C0221128 (UMLS CUI [7])
C0019761 (UMLS CUI [8])
C1518999 (UMLS CUI [9])
C1511246 (UMLS CUI [10])
Umbilical Cord Blood Unit Available | Nucleated cell Quantity | Histocompatibility crossmatch
Item
4. available cord blood unit must contain a minimum of 1.5 * 10^7 total nucleated cells per kg, and be at least a 4/6 hla match with patient.
boolean
C0162371 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C1180059 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0549171 (UMLS CUI [3])
Zubrod Performance Status | Lansky Play-Performance Status
Item
5. zubrod ps less than or equal to 2 or lansky ps greater than or equal to 50%.
boolean
C3714786 (UMLS CUI [1])
C1522275 (UMLS CUI [2])
Left ventricular ejection fraction | Cardiac Arrhythmia Uncontrolled Absent | Heart Disease Symptomatic Absent
Item
6. left ventricular ejection fraction >40%. no uncontrolled arrhythmias or symptomatic heart disease.
boolean
C0428772 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0018799 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
FEV1 | Forced vital capacity | Carbon Monoxide Diffusing Capability Test
Item
7. forced expiratory volume in 1 second (fev1), forced vital capacity (fvc) and diffusion capacity (dlco) >40%.
boolean
C0748133 (UMLS CUI [1])
C1287681 (UMLS CUI [2])
C1516251 (UMLS CUI [3])
Creatinine measurement, serum | Serum total bilirubin measurement
Item
8. serum creatinine <2.0 mg/dl. serum bilirubin <3 * upper limit of normal, sgpt <4 *
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Alanine aminotransferase measurement
Item
upper limit of normal.
boolean
C0201836 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CNS disorder
Item
1. patients with active cns disease
boolean
C0007682 (UMLS CUI [1])
Childbearing Potential Beta HCG positive | Postmenopausal state Absent | Female Sterilization Absent
Item
2. positive beta hcg in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
boolean
C3831118 (UMLS CUI [1,1])
C0813152 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0015787 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Illness Serious Interferes with Study Subject Participation Status | Mental disorder Serious Interferes with Study Subject Participation Status | Communicable Disease Uncontrolled | Cardiac Arrhythmia Uncontrolled | Event Ischemic | Psychotic Disorder Uncontrolled | Major Depressive Disorder | Manic Disorder
Item
3. serious medical or psychiatric illness likely to interfere with participation in this clinical study, including but not limited to active uncontrolled infection, uncontrolled cardiac arrhythmia or ischemic event, or uncontrolled psychosis, major depression, or mania.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0009450 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0441471 (UMLS CUI [5,1])
C0475224 (UMLS CUI [5,2])
C0033975 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C1269683 (UMLS CUI [7])
C0024713 (UMLS CUI [8])
Chronic Hepatitis Evidence of | Liver Cirrhosis Evidence of | HIV Infection Evidence of
Item
4. evidence of chronic, active hepatitis or cirrhosis, or hiv
boolean
C0019189 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0019693 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
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