ID

24505

Beschrijving

Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00466726

Link

https://clinicaltrials.gov/show/NCT00466726

Trefwoorden

Versies (1)
  1. 03-08-17 03-08-17 -
Geüploaded op

3 augustus 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Leukemia NCT00466726

Engels

Eligibility Leukemia NCT00466726

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00466726
Criteria
Beschrijving

Criteria

diagnosis of chronic myelogenous leukemia (cml) meeting the following criteria:
Beschrijving

Myeloid Leukemia, Chronic | Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1]
C0023473
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
philadelphia chromosome positive disease
Beschrijving

Disease Philadelphia chromosome positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0856536
b3a2 breakpoint mutation
Beschrijving

b3a2 Breakpoint Mutation

Datatype

boolean

Alias
UMLS CUI [1,1]
C1955181
UMLS CUI [1,2]
C2717920
UMLS CUI [1,3]
C0026882
prior treatment with conventional imatinib mesylate for ≥ 18 months required
Beschrijving

Imatinib mesylate

Datatype

boolean

Alias
UMLS CUI [1]
C0939537
complete cytogenetic response documented on ≥ 2 different examinations
Beschrijving

Cytogenetic Complete Response Examined Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C4050364
UMLS CUI [1,2]
C0332128
UMLS CUI [1,3]
C1265611
persistence of molecularly detectable residual disease (any level of bcr-abl transcript)
Beschrijving

Residual disease Persistence Molecular Detectable | BCR-ABL Transcript Level

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543478
UMLS CUI [1,2]
C0546816
UMLS CUI [1,3]
C1521991
UMLS CUI [1,4]
C3830527
UMLS CUI [2,1]
C1835417
UMLS CUI [2,2]
C1519595
UMLS CUI [2,3]
C0441889
patients continue to receive imatinib mesylate at the same dose (conventional treatment) during study treatment
Beschrijving

Imatinib mesylate Dose Same

Datatype

boolean

Alias
UMLS CUI [1,1]
C0939537
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0445247
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
who performance status 0-1
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
bilirubin ≤ 2 times upper limit of normal (uln)
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
ast and alt ≤ 2.5 times uln
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
creatinine ≤ 1.5 times uln
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
not pregnant or nursing
Beschrijving

Pregnancy Exclusion | Breast Feeding Exclusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C2828389
negative pregnancy test
Beschrijving

Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception
Beschrijving

Fertility Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no severe active infection or other serious medical illness that would preclude study completion
Beschrijving

Communicable Diseases Severe Exclude Completion of clinical trial | Illness Serious Excludes Completion of clinical trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C2732579
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0332196
UMLS CUI [2,4]
C2732579
no known immunodeficiency
Beschrijving

Immunologic Deficiency Syndromes Exclusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021051
UMLS CUI [1,2]
C2828389
no autoimmune disorders
Beschrijving

Autoimmune Diseases Exclusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C2828389
prior concurrent therapy:
Beschrijving

Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
no concurrent immunosuppression or systemic immunosuppressive medication
Beschrijving

Therapeutic immunosuppression Exclusion | Immunosuppressive Agents Systemic Exclusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C0205373
UMLS CUI [2,3]
C2828389
no concurrent dose escalation of imatinib mesylate
Beschrijving

Imatinib mesylate Dose Escalation Exclusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0939537
UMLS CUI [1,2]
C3816728
UMLS CUI [1,3]
C2828389
no other concurrent investigational products
Beschrijving

Investigational New Drugs Exclusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C2828389
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Similar models

Eligibility Leukemia NCT00466726

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00466726
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Myeloid Leukemia, Chronic | Criteria Fulfill
Item
diagnosis of chronic myelogenous leukemia (cml) meeting the following criteria:
boolean
C0023473 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Disease Philadelphia chromosome positive
Item
philadelphia chromosome positive disease
boolean
C0012634 (UMLS CUI [1,1])
C0856536 (UMLS CUI [1,2])
b3a2 Breakpoint Mutation
Item
b3a2 breakpoint mutation
boolean
C1955181 (UMLS CUI [1,1])
C2717920 (UMLS CUI [1,2])
C0026882 (UMLS CUI [1,3])
Imatinib mesylate
Item
prior treatment with conventional imatinib mesylate for ≥ 18 months required
boolean
C0939537 (UMLS CUI [1])
Cytogenetic Complete Response Examined Quantity
Item
complete cytogenetic response documented on ≥ 2 different examinations
boolean
C4050364 (UMLS CUI [1,1])
C0332128 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Residual disease Persistence Molecular Detectable | BCR-ABL Transcript Level
Item
persistence of molecularly detectable residual disease (any level of bcr-abl transcript)
boolean
C0543478 (UMLS CUI [1,1])
C0546816 (UMLS CUI [1,2])
C1521991 (UMLS CUI [1,3])
C3830527 (UMLS CUI [1,4])
C1835417 (UMLS CUI [2,1])
C1519595 (UMLS CUI [2,2])
C0441889 (UMLS CUI [2,3])
Imatinib mesylate Dose Same
Item
patients continue to receive imatinib mesylate at the same dose (conventional treatment) during study treatment
boolean
C0939537 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
WHO performance status scale
Item
who performance status 0-1
boolean
C1298650 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin ≤ 2 times upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast and alt ≤ 2.5 times uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
creatinine ≤ 1.5 times uln
boolean
C0201976 (UMLS CUI [1])
Pregnancy Exclusion | Breast Feeding Exclusion
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Communicable Diseases Severe Exclude Completion of clinical trial | Illness Serious Excludes Completion of clinical trial
Item
no severe active infection or other serious medical illness that would preclude study completion
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C2732579 (UMLS CUI [2,4])
Immunologic Deficiency Syndromes Exclusion
Item
no known immunodeficiency
boolean
C0021051 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Autoimmune Diseases Exclusion
Item
no autoimmune disorders
boolean
C0004364 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Therapeutic immunosuppression Exclusion | Immunosuppressive Agents Systemic Exclusion
Item
no concurrent immunosuppression or systemic immunosuppressive medication
boolean
C0021079 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Imatinib mesylate Dose Escalation Exclusion
Item
no concurrent dose escalation of imatinib mesylate
boolean
C0939537 (UMLS CUI [1,1])
C3816728 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
Investigational New Drugs Exclusion
Item
no other concurrent investigational products
boolean
C0013230 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Terug naar het begin van de pagina 

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