ID

17984

Descripción

Phase I Study of Sequential Cord Blood Transplants; ODM derived from: https://clinicaltrials.gov/show/NCT00299767

Link

https://clinicaltrials.gov/show/NCT00299767

Palabras clave

Versiones (1)
  1. 13/10/16 13/10/16 -
Subido en

13 de octubre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00299767

Inglés

Eligibility Lymphoma NCT00299767

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00299767
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
disease status: nhl, hd, or mm refractory to chemotherapy or relapsed; cll rai stage iii/iv, or lymphocyte doubling time of 6 months, or stage i/ii resistant to 2 chemotherapy regimens; aml or all in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder
Descripción

Disease | Non-Hodgkin Lymphoma Chemotherapy refractory | Hodgkin Disease Chemotherapy refractory | Multiple Myeloma Chemotherapy refractory | Non-Hodgkin Lymphoma Recurrent disease | Hodgkin Disease Recurrent disease | Multiple Myeloma Recurrent disease | Chronic Lymphocytic Leukemia | Rai Staging System | Lymphocyte Doubling Time | Chronic Lymphocytic Leukemia Chemotherapy Quantity Resistant | Acute myeloid leukemia in remission | Acute lymphoid leukemia in remission | Cytogenetic Analysis adverse effects | Hematological Disease antecedent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2,1]
C0024305
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0205269
UMLS CUI [3,1]
C0019829
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C0205269
UMLS CUI [4,1]
C0026764
UMLS CUI [4,2]
C0392920
UMLS CUI [4,3]
C0205269
UMLS CUI [5,1]
C0024305
UMLS CUI [5,2]
C0277556
UMLS CUI [6,1]
C0019829
UMLS CUI [6,2]
C0277556
UMLS CUI [7,1]
C0026764
UMLS CUI [7,2]
C0277556
UMLS CUI [8]
C0023434
UMLS CUI [9]
C1514715
UMLS CUI [10,1]
C0024264
UMLS CUI [10,2]
C2986483
UMLS CUI [11,1]
C0023434
UMLS CUI [11,2]
C0392920
UMLS CUI [11,3]
C1265611
UMLS CUI [11,4]
C0332325
UMLS CUI [12]
C0153886
UMLS CUI [13]
C0153876
UMLS CUI [14,1]
C0752095
UMLS CUI [14,2]
C0001688
UMLS CUI [15,1]
C0018939
UMLS CUI [15,2]
C0683336
estimated disease-free survival of less than one year
Descripción

Disease-Free Survival Estimated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0242793
UMLS CUI [1,2]
C0750572
ecog performance status of 0, 1, 2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
lack of 6/6 or 5/6 hla matched related or 6/6 matched unrelated donor, or a donor is not available within the time frame necessary to perform a potentially curative stem cell transplant
Descripción

Living related donor HLA Matched Quantity Lack | Unrelated Donors HLA Matched Quantity Lack | Donor Unavailable | Hemopoietic stem cell transplant Curative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3494891
UMLS CUI [1,2]
C1548978
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0332268
UMLS CUI [2,1]
C3179133
UMLS CUI [2,2]
C1548978
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0332268
UMLS CUI [3,1]
C0013018
UMLS CUI [3,2]
C0686905
UMLS CUI [4,1]
C0472699
UMLS CUI [4,2]
C1276305
4/6 or greater hla a, b, crb1 cord blood units with a combined nucleated cell dose from of > 3.7 x 10(7) nc/kg
Descripción

Cord blood specimen HLA-A Antigens Quantity | Cord blood specimen HLA-B Antigens Quantity | Cord blood specimen CRB1 protein Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0457279
UMLS CUI [1,2]
C0019728
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0457279
UMLS CUI [2,2]
C0019737
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0457279
UMLS CUI [3,2]
C1120837
UMLS CUI [3,3]
C1265611
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
cardiac disease: symptomatic congestive hearth failure or rvg or echocardiogram determined left ventricular ejection fraction of < 45%, active angina pectoris, or uncontrolled hypertension
Descripción

Heart Diseases | Symptomatic congestive heart failure | Radionuclide Ventriculography | Echocardiography | Left ventricular ejection fraction | Angina Pectoris | Uncontrolled hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0742758
UMLS CUI [3]
C0034610
UMLS CUI [4]
C0013516
UMLS CUI [5]
C0428772
UMLS CUI [6]
C0002962
UMLS CUI [7]
C1868885
pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected dlco of < 50%
Descripción

Lung diseases | Severe chronic obstructive pulmonary disease | Restrictive lung disease Symptomatic | DLCO Corrected

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0730607
UMLS CUI [3,1]
C0085581
UMLS CUI [3,2]
C0231220
UMLS CUI [4,1]
C1516251
UMLS CUI [4,2]
C0205202
renal disease: serum creatinine > 2.0 mg/dl
Descripción

Kidney Diseases | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0201976
hepatic disease: serum bilirubin > 2.0 mg/dl (except in the case of gilbert's syndrome), sgpt or sgot > 3 x normal
Descripción

Liver diseases | Serum total bilirubin measurement | Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0017551
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
neurologic disease: symptomatic leukoencephalopathy, active dns malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
Descripción

nervous system disorder | Leukoencephalopathy Symptomatic | Malignant Neoplasms | Neuropsychiatric syndrome Excludes Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2,1]
C0270612
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0006826
UMLS CUI [4,1]
C3203509
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0040732
hiv antibody or hepatitis b surface antigen positivity
Descripción

HIV Seropositivity | Hepatitis B surface antigen positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
uncontrolled infection
Descripción

Communicable Disease Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
pregnancy or breast-feeding mother
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Lymphoma NCT00299767

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00299767
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Disease | Non-Hodgkin Lymphoma Chemotherapy refractory | Hodgkin Disease Chemotherapy refractory | Multiple Myeloma Chemotherapy refractory | Non-Hodgkin Lymphoma Recurrent disease | Hodgkin Disease Recurrent disease | Multiple Myeloma Recurrent disease | Chronic Lymphocytic Leukemia | Rai Staging System | Lymphocyte Doubling Time | Chronic Lymphocytic Leukemia Chemotherapy Quantity Resistant | Acute myeloid leukemia in remission | Acute lymphoid leukemia in remission | Cytogenetic Analysis adverse effects | Hematological Disease antecedent
Item
disease status: nhl, hd, or mm refractory to chemotherapy or relapsed; cll rai stage iii/iv, or lymphocyte doubling time of 6 months, or stage i/ii resistant to 2 chemotherapy regimens; aml or all in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder
boolean
C0012634 (UMLS CUI [1])
C0024305 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0019829 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0205269 (UMLS CUI [3,3])
C0026764 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
C0205269 (UMLS CUI [4,3])
C0024305 (UMLS CUI [5,1])
C0277556 (UMLS CUI [5,2])
C0019829 (UMLS CUI [6,1])
C0277556 (UMLS CUI [6,2])
C0026764 (UMLS CUI [7,1])
C0277556 (UMLS CUI [7,2])
C0023434 (UMLS CUI [8])
C1514715 (UMLS CUI [9])
C0024264 (UMLS CUI [10,1])
C2986483 (UMLS CUI [10,2])
C0023434 (UMLS CUI [11,1])
C0392920 (UMLS CUI [11,2])
C1265611 (UMLS CUI [11,3])
C0332325 (UMLS CUI [11,4])
C0153886 (UMLS CUI [12])
C0153876 (UMLS CUI [13])
C0752095 (UMLS CUI [14,1])
C0001688 (UMLS CUI [14,2])
C0018939 (UMLS CUI [15,1])
C0683336 (UMLS CUI [15,2])
Disease-Free Survival Estimated
Item
estimated disease-free survival of less than one year
boolean
C0242793 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status of 0, 1, 2
boolean
C1520224 (UMLS CUI [1])
Living related donor HLA Matched Quantity Lack | Unrelated Donors HLA Matched Quantity Lack | Donor Unavailable | Hemopoietic stem cell transplant Curative
Item
lack of 6/6 or 5/6 hla matched related or 6/6 matched unrelated donor, or a donor is not available within the time frame necessary to perform a potentially curative stem cell transplant
boolean
C3494891 (UMLS CUI [1,1])
C1548978 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332268 (UMLS CUI [1,4])
C3179133 (UMLS CUI [2,1])
C1548978 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0332268 (UMLS CUI [2,4])
C0013018 (UMLS CUI [3,1])
C0686905 (UMLS CUI [3,2])
C0472699 (UMLS CUI [4,1])
C1276305 (UMLS CUI [4,2])
Cord blood specimen HLA-A Antigens Quantity | Cord blood specimen HLA-B Antigens Quantity | Cord blood specimen CRB1 protein Quantity
Item
4/6 or greater hla a, b, crb1 cord blood units with a combined nucleated cell dose from of > 3.7 x 10(7) nc/kg
boolean
C0457279 (UMLS CUI [1,1])
C0019728 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0457279 (UMLS CUI [2,1])
C0019737 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0457279 (UMLS CUI [3,1])
C1120837 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Heart Diseases | Symptomatic congestive heart failure | Radionuclide Ventriculography | Echocardiography | Left ventricular ejection fraction | Angina Pectoris | Uncontrolled hypertension
Item
cardiac disease: symptomatic congestive hearth failure or rvg or echocardiogram determined left ventricular ejection fraction of < 45%, active angina pectoris, or uncontrolled hypertension
boolean
C0018799 (UMLS CUI [1])
C0742758 (UMLS CUI [2])
C0034610 (UMLS CUI [3])
C0013516 (UMLS CUI [4])
C0428772 (UMLS CUI [5])
C0002962 (UMLS CUI [6])
C1868885 (UMLS CUI [7])
Lung diseases | Severe chronic obstructive pulmonary disease | Restrictive lung disease Symptomatic | DLCO Corrected
Item
pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected dlco of < 50%
boolean
C0024115 (UMLS CUI [1])
C0730607 (UMLS CUI [2])
C0085581 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C1516251 (UMLS CUI [4,1])
C0205202 (UMLS CUI [4,2])
Kidney Diseases | Creatinine measurement, serum
Item
renal disease: serum creatinine > 2.0 mg/dl
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver diseases | Serum total bilirubin measurement | Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
hepatic disease: serum bilirubin > 2.0 mg/dl (except in the case of gilbert's syndrome), sgpt or sgot > 3 x normal
boolean
C0023895 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0017551 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
nervous system disorder | Leukoencephalopathy Symptomatic | Malignant Neoplasms | Neuropsychiatric syndrome Excludes Transplantation
Item
neurologic disease: symptomatic leukoencephalopathy, active dns malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
boolean
C0027765 (UMLS CUI [1])
C0270612 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3])
C3203509 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0040732 (UMLS CUI [4,3])
HIV Seropositivity | Hepatitis B surface antigen positive
Item
hiv antibody or hepatitis b surface antigen positivity
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Communicable Disease Uncontrolled
Item
uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding mother
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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