ID

30167

Descrizione

Autologous Stem Cell Transplants for Chronic Myelogenous Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00446173

collegamento

https://clinicaltrials.gov/show/NCT00446173

Keywords

versioni (1)
  1. 16/05/18 16/05/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

16 maggio 2018

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Leukemia NCT00446173

Inglese

Eligibility Leukemia NCT00446173

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00446173
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with philadelphia (ph) chromosome positive cml < age 65 and older than 21 years.
Descrizione

Philadelphia chromosome positive CML | Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0279543
UMLS CUI [2]
C0001779
ph positive cml that is either in: 1. late 1st chronic phase (> 2 years from diagnosis) 2. early chronic phase who did not achieve complete cytogenetic remission after one year on imatinib 3. beyond first chronic phase 4. accelerated phase 5. blastic phase that has responded to therapy (characterized by the presence of < 10% bone marrow and/or circulating blasts at consent signing) 6. chronic phase, developing imatinib resistance (loss of molecular remission defined as at least a 1 log increase in the bcr-abl/abl ratio, in 2 time points at least 1 month apart, or loss of cytogenetic remission)
Descrizione

Philadelphia chromosome positive CML Chronic phase First Late | Philadelphia chromosome positive CML Chronic phase Early | Cytogenetic Complete Response failed | Imatinib | Philadelphia chromosome positive CML Except Chronic phase First | Philadelphia chromosome positive CML Accelerated phase | Philadelphia chromosome positive CML Blastic Phase | Disease Response | Bone Marrow Percentage | Blast cells present | Philadelphia chromosome positive CML Chronic phase | Imatinib Resistance | Loss Molecular Complete Response | Other Coding | Loss Cytogenetic Complete Response

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0279543
UMLS CUI [1,2]
C0457343
UMLS CUI [1,3]
C0205435
UMLS CUI [1,4]
C0205087
UMLS CUI [2,1]
C0279543
UMLS CUI [2,2]
C0457343
UMLS CUI [2,3]
C1279919
UMLS CUI [3,1]
C4050364
UMLS CUI [3,2]
C0231175
UMLS CUI [4]
C0935989
UMLS CUI [5,1]
C0279543
UMLS CUI [5,2]
C0332300
UMLS CUI [5,3]
C0457343
UMLS CUI [5,4]
C0205435
UMLS CUI [6,1]
C0279543
UMLS CUI [6,2]
C0457345
UMLS CUI [7,1]
C0279543
UMLS CUI [7,2]
C3899938
UMLS CUI [8]
C1704632
UMLS CUI [9,1]
C0005953
UMLS CUI [9,2]
C0439165
UMLS CUI [10]
C0427540
UMLS CUI [11,1]
C0279543
UMLS CUI [11,2]
C0457343
UMLS CUI [12,1]
C0935989
UMLS CUI [12,2]
C1514892
UMLS CUI [13,1]
C1517945
UMLS CUI [13,2]
C4050308
UMLS CUI [14]
C3846158
UMLS CUI [15,1]
C1517945
UMLS CUI [15,2]
C4050364
patients must have a zubrod ps < 3. creatinine < 1.8 mg/dl
Descrizione

Zubrod Performance Status | Creatinine measurement, serum

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3714786
UMLS CUI [2]
C0201976
serum bilirubin </= 1.5 mg/dl
Descrizione

Serum total bilirubin measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1278039
sgpt < 3 x normal values
Descrizione

Alanine aminotransferase measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201836
patients with an hla identical sibling are eligible if they refuse allogeneic transplantation, or if they are ineligible for allogeneic transplantation due to age.
Descrizione

Sibling HLA Identical | Homologous Transplantation Refused | Ineligibility Homologous Transplantation | Etiology Age

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0037047
UMLS CUI [1,2]
C0019721
UMLS CUI [1,3]
C0205280
UMLS CUI [2,1]
C0040739
UMLS CUI [2,2]
C1705116
UMLS CUI [3,1]
C1512714
UMLS CUI [3,2]
C0040739
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0001779
dlco >/= 50% of predicted
Descrizione

Carbon Monoxide Diffusing Capability Test

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1516251
cardiac ejection fraction >/= 40%
Descrizione

Cardiac ejection fraction

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232174
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled life-threatening infections or comorbid condition that could impair tolerance to the regimen.
Descrizione

Communicable Diseases Life Threatening Uncontrolled | Comorbidity Impairing Therapeutic procedure

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0087111
hiv positivity.
Descrizione

HIV Seropositivity

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019699
pregnant or lactating women.
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
cml in blastic phase that has not responded to therapy given prior to enrollment in this study (characterized by the presence of more than 9% bone marrow and/or peripheral blood blasts at the time of consent signing)
Descrizione

Blastic Phase CML Unresponsive to Treatment | Bone Marrow Percentage | Blast Cells Present in Peripheral Blood

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005699
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0439165
UMLS CUI [3]
C1332566
hepatitis b or c virus infection. hepatitis b infection defined by positive dna test, positive e and / or surface antigen.
Descrizione

Hepatitis B | Hepatitis C | Hepatitis B DNA assay positive | Hepatitis B e antigen positive | Hepatitis B surface antigen positive

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C1168040
UMLS CUI [4]
C0392390
UMLS CUI [5]
C0149709
cml in first molecular remission.
Descrizione

CML Molecular Complete Response First

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0023473
UMLS CUI [1,2]
C4050308
UMLS CUI [1,3]
C0205435
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Similar models

Eligibility Leukemia NCT00446173

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00446173
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Philadelphia chromosome positive CML | Age
Item
patients with philadelphia (ph) chromosome positive cml < age 65 and older than 21 years.
boolean
C0279543 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Philadelphia chromosome positive CML Chronic phase First Late | Philadelphia chromosome positive CML Chronic phase Early | Cytogenetic Complete Response failed | Imatinib | Philadelphia chromosome positive CML Except Chronic phase First | Philadelphia chromosome positive CML Accelerated phase | Philadelphia chromosome positive CML Blastic Phase | Disease Response | Bone Marrow Percentage | Blast cells present | Philadelphia chromosome positive CML Chronic phase | Imatinib Resistance | Loss Molecular Complete Response | Other Coding | Loss Cytogenetic Complete Response
Item
ph positive cml that is either in: 1. late 1st chronic phase (> 2 years from diagnosis) 2. early chronic phase who did not achieve complete cytogenetic remission after one year on imatinib 3. beyond first chronic phase 4. accelerated phase 5. blastic phase that has responded to therapy (characterized by the presence of < 10% bone marrow and/or circulating blasts at consent signing) 6. chronic phase, developing imatinib resistance (loss of molecular remission defined as at least a 1 log increase in the bcr-abl/abl ratio, in 2 time points at least 1 month apart, or loss of cytogenetic remission)
boolean
C0279543 (UMLS CUI [1,1])
C0457343 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0205087 (UMLS CUI [1,4])
C0279543 (UMLS CUI [2,1])
C0457343 (UMLS CUI [2,2])
C1279919 (UMLS CUI [2,3])
C4050364 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0935989 (UMLS CUI [4])
C0279543 (UMLS CUI [5,1])
C0332300 (UMLS CUI [5,2])
C0457343 (UMLS CUI [5,3])
C0205435 (UMLS CUI [5,4])
C0279543 (UMLS CUI [6,1])
C0457345 (UMLS CUI [6,2])
C0279543 (UMLS CUI [7,1])
C3899938 (UMLS CUI [7,2])
C1704632 (UMLS CUI [8])
C0005953 (UMLS CUI [9,1])
C0439165 (UMLS CUI [9,2])
C0427540 (UMLS CUI [10])
C0279543 (UMLS CUI [11,1])
C0457343 (UMLS CUI [11,2])
C0935989 (UMLS CUI [12,1])
C1514892 (UMLS CUI [12,2])
C1517945 (UMLS CUI [13,1])
C4050308 (UMLS CUI [13,2])
C3846158 (UMLS CUI [14])
C1517945 (UMLS CUI [15,1])
C4050364 (UMLS CUI [15,2])
Zubrod Performance Status | Creatinine measurement, serum
Item
patients must have a zubrod ps < 3. creatinine < 1.8 mg/dl
boolean
C3714786 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Serum total bilirubin measurement
Item
serum bilirubin </= 1.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
sgpt < 3 x normal values
boolean
C0201836 (UMLS CUI [1])
Sibling HLA Identical | Homologous Transplantation Refused | Ineligibility Homologous Transplantation | Etiology Age
Item
patients with an hla identical sibling are eligible if they refuse allogeneic transplantation, or if they are ineligible for allogeneic transplantation due to age.
boolean
C0037047 (UMLS CUI [1,1])
C0019721 (UMLS CUI [1,2])
C0205280 (UMLS CUI [1,3])
C0040739 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
C1512714 (UMLS CUI [3,1])
C0040739 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0001779 (UMLS CUI [4,2])
Carbon Monoxide Diffusing Capability Test
Item
dlco >/= 50% of predicted
boolean
C1516251 (UMLS CUI [1])
Cardiac ejection fraction
Item
cardiac ejection fraction >/= 40%
boolean
C0232174 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Diseases Life Threatening Uncontrolled | Comorbidity Impairing Therapeutic procedure
Item
uncontrolled life-threatening infections or comorbid condition that could impair tolerance to the regimen.
boolean
C0009450 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
HIV Seropositivity
Item
hiv positivity.
boolean
C0019699 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Blastic Phase CML Unresponsive to Treatment | Bone Marrow Percentage | Blast Cells Present in Peripheral Blood
Item
cml in blastic phase that has not responded to therapy given prior to enrollment in this study (characterized by the presence of more than 9% bone marrow and/or peripheral blood blasts at the time of consent signing)
boolean
C0005699 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0005953 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1332566 (UMLS CUI [3])
Hepatitis B | Hepatitis C | Hepatitis B DNA assay positive | Hepatitis B e antigen positive | Hepatitis B surface antigen positive
Item
hepatitis b or c virus infection. hepatitis b infection defined by positive dna test, positive e and / or surface antigen.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C1168040 (UMLS CUI [3])
C0392390 (UMLS CUI [4])
C0149709 (UMLS CUI [5])
CML Molecular Complete Response First
Item
cml in first molecular remission.
boolean
C0023473 (UMLS CUI [1,1])
C4050308 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
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