ID

13146

Description

Study Using Vaccination With Heat Shock Protein 70 (HSP70) for the Treatment of CML in Chronic Phase; ODM derived from: https://clinicaltrials.gov/show/NCT00027144

Link

https://clinicaltrials.gov/show/NCT00027144

Keywords

Versions (1)
  1. 1/19/16 1/19/16 -
Uploaded on

January 19, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia,Myeloid, Chronic NCT00027144

English

Eligibility Leukemia,Myeloid, Chronic NCT00027144

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
ecog performance score(ps) less than 2.
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
must be at least 18 years of age and capable of giving informed consent.
Description

age, informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
must be less than three years from the original diagnosis of philadelphia chromosome positive cml in chronic phase.
Description

philadelphia chromosome positive cml in chronic phase

Data type

boolean

Alias
UMLS CUI [1,1]
C0023474
UMLS CUI [1,2]
C0856536
patient is not in cytogenetic remission.
Description

remission

Data type

boolean

Alias
UMLS CUI [1]
C0544452
no anticipation of bone marrow or stem cell transplant for six months unless these therapies are deemed necessary by a treatment physician due to the evolution of the disease;
Description

transplant

Data type

boolean

Alias
UMLS CUI [1]
C0472699
concurrent treatment with hydroxyurea or gleevec is allowed.past treatment with ifn alpha, ara-c or other cytoxic agents is allowed
Description

medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
must not have any serious illness such that their medical condition might be compromised by participation in the study.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
must have adequate renal function (serum creatinine < 2.0), hepatic function (bilirubin and transaminase less than 2.0 x of the upper normal limit).
Description

creatinine, bilirubin, transaminases

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0002594
must not be on corticosteroid therapy, or other immunosuppressive medications.
Description

immunosuppressive agents

Data type

boolean

Alias
UMLS CUI [1]
C0021081
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI-1
C0680251
patients with an ecog performance score greater than or equal to 2.
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patient is greater than or equal to 3 years out from the original diagnosis.
Description

time of diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0040223
significant anemia (hemoglobin < 10 g/dl) and thrombocytopenia (platelet < 20,000/ml) requiring transfusion.
Description

transfusion

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0032181
UMLS CUI [3]
C1879316
peripheral blast count is over 10%.
Description

peripheral blast count

Data type

boolean

Alias
UMLS CUI [1]
C0523113
positive urine or blood pregnancy test.
Description

pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
impaired renal function (serum creatinine > 2.0), hepatic function (bilirubin and transaminase more than 2.0 x of the upper normal limit).
Description

creatinine, bilirubin, transaminases

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0002594
patient with significant active infection requiring hospitalization at the time of enrollment.
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
patient with significant behavioral or psychological problems that prevent adequate follow-up.
Description

follow-up

Data type

boolean

Alias
UMLS CUI [1]
C1522577
concurrent treatment with ifn alpha ara-c or other cytotoxic agents (gleevec and hydroxyurea are allowed.
Description

concurrent treatment

Data type

boolean

Alias
UMLS CUI [1]
C0013227
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Similar models

Eligibility Leukemia,Myeloid, Chronic NCT00027144

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
ecog
Item
ecog performance score(ps) less than 2.
boolean
C1520224 (UMLS CUI [1])
age, informed consent
Item
must be at least 18 years of age and capable of giving informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
philadelphia chromosome positive cml in chronic phase
Item
must be less than three years from the original diagnosis of philadelphia chromosome positive cml in chronic phase.
boolean
C0023474 (UMLS CUI [1,1])
C0856536 (UMLS CUI [1,2])
remission
Item
patient is not in cytogenetic remission.
boolean
C0544452 (UMLS CUI [1])
transplant
Item
no anticipation of bone marrow or stem cell transplant for six months unless these therapies are deemed necessary by a treatment physician due to the evolution of the disease;
boolean
C0472699 (UMLS CUI [1])
medication
Item
concurrent treatment with hydroxyurea or gleevec is allowed.past treatment with ifn alpha, ara-c or other cytoxic agents is allowed
boolean
C0013227 (UMLS CUI [1])
comorbidity
Item
must not have any serious illness such that their medical condition might be compromised by participation in the study.
boolean
C0009488 (UMLS CUI [1])
creatinine, bilirubin, transaminases
Item
must have adequate renal function (serum creatinine < 2.0), hepatic function (bilirubin and transaminase less than 2.0 x of the upper normal limit).
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0002594 (UMLS CUI [3])
immunosuppressive agents
Item
must not be on corticosteroid therapy, or other immunosuppressive medications.
boolean
C0021081 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
ecog
Item
patients with an ecog performance score greater than or equal to 2.
boolean
C1520224 (UMLS CUI [1])
time of diagnosis
Item
patient is greater than or equal to 3 years out from the original diagnosis.
boolean
C0011900 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
transfusion
Item
significant anemia (hemoglobin < 10 g/dl) and thrombocytopenia (platelet < 20,000/ml) requiring transfusion.
boolean
C0518015 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C1879316 (UMLS CUI [3])
peripheral blast count
Item
peripheral blast count is over 10%.
boolean
C0523113 (UMLS CUI [1])
pregnancy test
Item
positive urine or blood pregnancy test.
boolean
C0032976 (UMLS CUI [1])
creatinine, bilirubin, transaminases
Item
impaired renal function (serum creatinine > 2.0), hepatic function (bilirubin and transaminase more than 2.0 x of the upper normal limit).
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0002594 (UMLS CUI [3])
infection
Item
patient with significant active infection requiring hospitalization at the time of enrollment.
boolean
C0009450 (UMLS CUI [1])
follow-up
Item
patient with significant behavioral or psychological problems that prevent adequate follow-up.
boolean
C1522577 (UMLS CUI [1])
concurrent treatment
Item
concurrent treatment with ifn alpha ara-c or other cytotoxic agents (gleevec and hydroxyurea are allowed.
boolean
C0013227 (UMLS CUI [1])
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