ID

24505

Description

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

Keywords

Versions (1)
  1. 8/3/17 8/3/17 -
Uploaded on

August 3, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Leukemia NCT00466726

English

Eligibility Leukemia NCT00466726

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00466726
Criteria
Description

Criteria

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

Myeloid Leukemia, Chronic | Criteria Fulfill

Data type

boolean

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

Disease Philadelphia chromosome positive

Data type

boolean

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

b3a2 Breakpoint Mutation

Data type

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
Description

Imatinib mesylate

Data type

boolean

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

Cytogenetic Complete Response Examined Quantity

Data type

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)
Description

Residual disease Persistence Molecular Detectable | BCR-ABL Transcript Level

Data type

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
Description

Imatinib mesylate Dose Same

Data type

boolean

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

Client Characteristics

Data type

boolean

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

WHO performance status scale

Data type

boolean

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

Serum total bilirubin measurement

Data type

boolean

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

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

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

Creatinine measurement, serum

Data type

boolean

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

Pregnancy Exclusion | Breast Feeding Exclusion

Data type

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
Description

Pregnancy test negative

Data type

boolean

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

Fertility Contraceptive methods

Data type

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
Description

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

Data type

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
Description

Immunologic Deficiency Syndromes Exclusion

Data type

boolean

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

Autoimmune Diseases Exclusion

Data type

boolean

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

Therapeutic procedure

Data type

boolean

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

Therapeutic immunosuppression Exclusion | Immunosuppressive Agents Systemic Exclusion

Data type

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
Description

Imatinib mesylate Dose Escalation Exclusion

Data type

boolean

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

Investigational New Drugs Exclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C2828389
Back to the top of the page

Similar models

Eligibility Leukemia NCT00466726

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00466726
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial