ID

17965

Beschreibung

Non-Myeloablative HLA-Matched Ex-Vivo T-Cell Depleted Stem Cell Transplantation for Hematologic Malignancies; ODM derived from: https://clinicaltrials.gov/show/NCT00113828

Link

https://clinicaltrials.gov/show/NCT00113828

Stichworte

Versionen (1)
  1. 12.10.16 12.10.16 -
Hochgeladen am

12. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00113828

Englisch

Eligibility Lymphoma NCT00113828

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00113828
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
disease statue: nhl, hd, or mm that are chemorefractory or relapsed; cll that is rai stage iii/iv, or lymphocyte doubling time of 6 months, or stage i/ii that is resistant to > 2 chemotherapy regimens; aml or all in 1st or subsequent remission with poor prognostic features; cml in accelerated or blast phae; mds with life-threatening cytopenias; patients who have had a previous autologous or allogeneic bone marrow or stem cell transplant; other hematologic disorders which allogeneic stem cell transplantation is appropriate where the risk of conventional transplantation is considered to be unacceptably high.
Beschreibung

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 Prognosis bad | Acute lymphoid leukemia in remission Prognosis bad | Leukemia, Myeloid, Accelerated Phase | Blast Phase | MYELODYSPLASTIC SYNDROME | Cytopenia Life Threatening | Autologous bone marrow transplant | Allogeneic bone marrow transplantation | Transplantation of autologous hematopoietic stem cell | Allogeneic Stem Cell Transplantation | Hematological Disease

Datentyp

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 [12,1]
C0153886
UMLS CUI [12,2]
C0278252
UMLS CUI [13,1]
C0153876
UMLS CUI [13,2]
C0278252
UMLS CUI [14]
C0023472
UMLS CUI [15]
C0005699
UMLS CUI [16]
C3463824
UMLS CUI [17,1]
C0010828
UMLS CUI [17,2]
C2826244
UMLS CUI [18]
C0194037
UMLS CUI [19]
C0149615
UMLS CUI [20]
C1831743
UMLS CUI [21]
C2242529
UMLS CUI [22]
C0018939
estimated disease-free survival of less than one year
Beschreibung

Disease-Free Survival Estimated

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
hla-genotypically or phenotypically matched (at a, b, dr loci) related donor
Beschreibung

Related donor HLA Matched Genotype | Related donor HLA Matched Phenotype | Genetic Loci | HLA-A | HLA-B | HLA-DR

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3494891
UMLS CUI [1,2]
C1548978
UMLS CUI [1,3]
C0017431
UMLS CUI [2,1]
C3494891
UMLS CUI [2,2]
C1548978
UMLS CUI [2,3]
C0031437
UMLS CUI [3]
C0678933
UMLS CUI [4]
C0019728
UMLS CUI [5]
C0019737
UMLS CUI [6]
C0019764
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who life expectancy is limited by diseases other than their hematologic malignancy.
Beschreibung

Life Expectancy Limited Due to Disease | Hematologic Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0012634
UMLS CUI [2]
C0376545
cardiac disease: symptomatic congestive hearth failure, or rvg, or ejection fraction of < 45%, active angina pectoris, or uncontrolled hypertension.
Beschreibung

Heart Diseases | Symptomatic congestive heart failure | Radionuclide Ventriculography | Cardiac ejection fraction | Angina Pectoris | Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0742758
UMLS CUI [3]
C0034610
UMLS CUI [4]
C0232174
UMLS CUI [5]
C0002962
UMLS CUI [6]
C1868885
pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or dlco of < 50%.
Beschreibung

Lung diseases | Severe chronic obstructive pulmonary disease | Restrictive lung disease Symptomatic | Carbon Monoxide Diffusing Capability Test

Datentyp

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0730607
UMLS CUI [3,1]
C0085581
UMLS CUI [3,2]
C0231220
UMLS CUI [4]
C1516251
renal disease: serum creatinine > 2.0 mg/dl or creatinine clearance < 50 ml/min.
Beschreibung

Kidney Diseases | Creatinine measurement, serum | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
hepatic disease: serum bilirubin > 2.0 mg/dl or alkaline phosphatase, sgot or sgpt > 3 times normal.
Beschreibung

Liver diseases | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201850
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
neurologic disease: symptomatic leukoencephalopathy, active cns malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
Beschreibung

nervous system disorder Excludes Transplantation | Leukoencephalopathies Symptomatic | Malignant neoplasm of central nervous system | Neuropsychiatric syndrome

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0040732
UMLS CUI [2,1]
C0270612
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0348374
UMLS CUI [4]
C3203509
hiv or htlv i antibody or hepatitis b surface antigen positivity
Beschreibung

HIV | HTLV-I Antibodies | Hepatitis B surface antigen positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0020095
UMLS CUI [3]
C0149709
uncontrolled infection
Beschreibung

Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
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Ähnliche Modelle

Eligibility Lymphoma NCT00113828

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00113828
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 Prognosis bad | Acute lymphoid leukemia in remission Prognosis bad | Leukemia, Myeloid, Accelerated Phase | Blast Phase | MYELODYSPLASTIC SYNDROME | Cytopenia Life Threatening | Autologous bone marrow transplant | Allogeneic bone marrow transplantation | Transplantation of autologous hematopoietic stem cell | Allogeneic Stem Cell Transplantation | Hematological Disease
Item
disease statue: nhl, hd, or mm that are chemorefractory or relapsed; cll that is rai stage iii/iv, or lymphocyte doubling time of 6 months, or stage i/ii that is resistant to > 2 chemotherapy regimens; aml or all in 1st or subsequent remission with poor prognostic features; cml in accelerated or blast phae; mds with life-threatening cytopenias; patients who have had a previous autologous or allogeneic bone marrow or stem cell transplant; other hematologic disorders which allogeneic stem cell transplantation is appropriate where the risk of conventional transplantation is considered to be unacceptably high.
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 [12,1])
C0278252 (UMLS CUI [12,2])
C0153876 (UMLS CUI [13,1])
C0278252 (UMLS CUI [13,2])
C0023472 (UMLS CUI [14])
C0005699 (UMLS CUI [15])
C3463824 (UMLS CUI [16])
C0010828 (UMLS CUI [17,1])
C2826244 (UMLS CUI [17,2])
C0194037 (UMLS CUI [18])
C0149615 (UMLS CUI [19])
C1831743 (UMLS CUI [20])
C2242529 (UMLS CUI [21])
C0018939 (UMLS CUI [22])
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, or 2
boolean
C1520224 (UMLS CUI [1])
Related donor HLA Matched Genotype | Related donor HLA Matched Phenotype | Genetic Loci | HLA-A | HLA-B | HLA-DR
Item
hla-genotypically or phenotypically matched (at a, b, dr loci) related donor
boolean
C3494891 (UMLS CUI [1,1])
C1548978 (UMLS CUI [1,2])
C0017431 (UMLS CUI [1,3])
C3494891 (UMLS CUI [2,1])
C1548978 (UMLS CUI [2,2])
C0031437 (UMLS CUI [2,3])
C0678933 (UMLS CUI [3])
C0019728 (UMLS CUI [4])
C0019737 (UMLS CUI [5])
C0019764 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Life Expectancy Limited Due to Disease | Hematologic Neoplasms
Item
patients who life expectancy is limited by diseases other than their hematologic malignancy.
boolean
C0023671 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
C0376545 (UMLS CUI [2])
Heart Diseases | Symptomatic congestive heart failure | Radionuclide Ventriculography | Cardiac ejection fraction | Angina Pectoris | Uncontrolled hypertension
Item
cardiac disease: symptomatic congestive hearth failure, or rvg, or ejection fraction of < 45%, active angina pectoris, or uncontrolled hypertension.
boolean
C0018799 (UMLS CUI [1])
C0742758 (UMLS CUI [2])
C0034610 (UMLS CUI [3])
C0232174 (UMLS CUI [4])
C0002962 (UMLS CUI [5])
C1868885 (UMLS CUI [6])
Lung diseases | Severe chronic obstructive pulmonary disease | Restrictive lung disease Symptomatic | Carbon Monoxide Diffusing Capability Test
Item
pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or 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])
Kidney Diseases | Creatinine measurement, serum | Creatinine clearance measurement
Item
renal disease: serum creatinine > 2.0 mg/dl or creatinine clearance < 50 ml/min.
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Liver diseases | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
hepatic disease: serum bilirubin > 2.0 mg/dl or alkaline phosphatase, sgot or sgpt > 3 times normal.
boolean
C0023895 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
nervous system disorder Excludes Transplantation | Leukoencephalopathies Symptomatic | Malignant neoplasm of central nervous system | Neuropsychiatric syndrome
Item
neurologic disease: symptomatic leukoencephalopathy, active cns malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
boolean
C0027765 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
C0270612 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0348374 (UMLS CUI [3])
C3203509 (UMLS CUI [4])
HIV | HTLV-I Antibodies | Hepatitis B surface antigen positive
Item
hiv or htlv i antibody or hepatitis b surface antigen positivity
boolean
C0019682 (UMLS CUI [1])
C0020095 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
Communicable Disease Uncontrolled
Item
uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
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