ID

21403

Beschrijving

Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF and PEG-INTRON(R); ODM derived from: https://clinicaltrials.gov/show/NCT00415857

Link

https://clinicaltrials.gov/show/NCT00415857

Trefwoorden

Versies (1)
  1. 19-04-17 19-04-17 -
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19 april 2017

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia NCT00415857

Engels

Eligibility Leukemia NCT00415857

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00415857
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients >/= 18 years with philadelphia chromosome (ph)- or bcr/ablpositive cml (as determined by cytogenetics, fish, or pcr).
Beschrijving

Age | Chronic Myeloid Leukemia Philadelphia negative Cytogenetic Analysis | BCR/ABL positive Chronic myelogenous leukemia Cytogenetic Analysis | Fluorescent in Situ Hybridization | Polymerase Chain Reaction

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0023473
UMLS CUI [2,2]
C0457341
UMLS CUI [2,3]
C0752095
UMLS CUI [3,1]
C1292771
UMLS CUI [3,2]
C0752095
UMLS CUI [4]
C0162789
UMLS CUI [5]
C0032520
2. patients must have received imatinib therapy for at least 18 months and not have increased their dose of imatinib in the last 6 months.
Beschrijving

imatinib | Dose Increased Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0935989
UMLS CUI [2,1]
C1707810
UMLS CUI [2,2]
C0332197
3. patients must be in complete cytogenetic remission.
Beschrijving

Cytogenetic Complete Response

Datatype

boolean

Alias
UMLS CUI [1]
C4050364
4. patients must have detectable bcr-abl transcript levels meeting at least one of the following criteria: 1) patient has never achieved a major molecular response (i.e., never reached levels <0.05%), and transcript levels have shown in at least two consecutive measures separated by at least 1 month to have increased by any value, or
Beschrijving

bcr-abl Transcript Levels Detectable | Molecular Major Response failed | Transcript Levels Increased | Measurement Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004891
UMLS CUI [1,2]
C3481430
UMLS CUI [1,3]
C0441889
UMLS CUI [1,4]
C3830527
UMLS CUI [2,1]
C4049637
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C3481430
UMLS CUI [3,2]
C0441889
UMLS CUI [3,3]
C0205217
UMLS CUI [4,1]
C0242485
UMLS CUI [4,2]
C1265611
5. continued from above: 2) achieved a major molecular response that has been lost with an increase in transcript levels by at least 1-log over two consecutive analyses separated by at least 1 month, or 3) bcr-abl transcript levels have reached a plateau defined as a ratio that is not more than 0.25-log (one fourth of a log) lower than the lowest value obtained in the last at least 6 months, with at least 2 values obtained during this period.
Beschrijving

Molecular Major Response achieved | Transcript Levels Increased | Molecular Major Response lost | Analysis Quantity | bcr-abl Transcript Levels

Datatype

boolean

Alias
UMLS CUI [1,1]
C4049637
UMLS CUI [1,2]
C1272277
UMLS CUI [2,1]
C3481430
UMLS CUI [2,2]
C0441889
UMLS CUI [2,3]
C0205217
UMLS CUI [3,1]
C4049637
UMLS CUI [3,2]
C0745777
UMLS CUI [4,1]
C0002778
UMLS CUI [4,2]
C1265611
UMLS CUI [5,1]
C0004891
UMLS CUI [5,2]
C3481430
UMLS CUI [5,3]
C0441889
6. patients must not have had a continuous interruption of imatinib therapy of greater than 14 days or any interruptions totaling 6 weeks within the 6 months prior to enrollment.
Beschrijving

imatinib | Therapy interrupted Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0935989
UMLS CUI [2,1]
C1710384
UMLS CUI [2,2]
C0332197
7. patients must be hla-a2 positive at one allele
Beschrijving

HLA-A2 Positive | Allele Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019733
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0002085
UMLS CUI [2,2]
C1265611
8. patients must give informed consent and sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
Beschrijving

Informed Consent | Compliance behavior

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
9. eastern cooperative oncology group (ecog) performance status </= 2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
10. adequate organ function defined as: bilirubin <2 times upper limit of normal (uln), creatinine <1.5 times uln, and serum glutamate pyruvate transaminase (sgpt) <2.5 times uln.
Beschrijving

Organ function | Serum total bilirubin measurement | Creatinine measurement, serum | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0201836
11. women of childbearing potential should practice effective methods of contraception.
Beschrijving

Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with a history or clinical evidence of autoimmune disorders
Beschrijving

Autoimmune Diseases Evidence Clinical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205210
2. patients receiving immunosuppressive therapy including cyclosporine, or fk506 within 3 months of study entry
Beschrijving

Therapeutic immunosuppression | Cyclosporine | FK-506

Datatype

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0010592
UMLS CUI [3]
C0729218
3. chronic use (> 2 weeks) of greater than physiologic doses of corticosteroid agent (dose equivalent to > 10 mg/day of prednisone) within 28 days of the first day of study drug treatment (topical and inhaled corticosteroids are permitted)
Beschrijving

Adrenal Cortex Hormones High dose Chronic | Prednisone | Topical corticosteroids | inhaled steroids

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0444956
UMLS CUI [1,3]
C0205191
UMLS CUI [2]
C0032952
UMLS CUI [3]
C0304604
UMLS CUI [4]
C2065041
4. gm-csf or interferon administration within 1 month of first pr1 injection
Beschrijving

Granulocyte-Macrophage Colony-Stimulating Factor | Interferon

Datatype

boolean

Alias
UMLS CUI [1]
C0079460
UMLS CUI [2]
C0021747
5. patients receiving any other investigational agents currently or within the past 4 weeks. patients must have recovered from any adverse effects of investigational therapy.
Beschrijving

Investigational New Drugs | Investigational Therapy Adverse effects Patient recovered

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0879626
UMLS CUI [2,3]
C1115804
6. patients who are pregnant or breast-feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. patients with clinically significant heart disease (new york heart association (nyha) class iii or iv)
Beschrijving

Heart Disease New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
8. patients with positive canca
Beschrijving

c-ANCA positive

Datatype

boolean

Alias
UMLS CUI [1]
C0238874
9. history of hiv positivity or aids
Beschrijving

HIV Seropositivity | Acquired Immunodeficiency Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0001175
10. chloroma at time of study screening
Beschrijving

Chloroma

Datatype

boolean

Alias
UMLS CUI [1]
C0152276
11. prior vaccine therapy for chronic myelogenous leukemia (cml)
Beschrijving

Vaccine Therapy Chronic Myeloid Leukemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042209
UMLS CUI [1,2]
C0023473
12. known allergy to montanide isa-51 vg adjuvant
Beschrijving

Hypersensitivity Montanide ISA 51 VG Adjuvant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2827521
UMLS CUI [1,3]
C0001552
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Similar models

Eligibility Leukemia NCT00415857

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00415857
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Chronic Myeloid Leukemia Philadelphia negative Cytogenetic Analysis | BCR/ABL positive Chronic myelogenous leukemia Cytogenetic Analysis | Fluorescent in Situ Hybridization | Polymerase Chain Reaction
Item
1. patients >/= 18 years with philadelphia chromosome (ph)- or bcr/ablpositive cml (as determined by cytogenetics, fish, or pcr).
boolean
C0001779 (UMLS CUI [1])
C0023473 (UMLS CUI [2,1])
C0457341 (UMLS CUI [2,2])
C0752095 (UMLS CUI [2,3])
C1292771 (UMLS CUI [3,1])
C0752095 (UMLS CUI [3,2])
C0162789 (UMLS CUI [4])
C0032520 (UMLS CUI [5])
imatinib | Dose Increased Absent
Item
2. patients must have received imatinib therapy for at least 18 months and not have increased their dose of imatinib in the last 6 months.
boolean
C0935989 (UMLS CUI [1])
C1707810 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Cytogenetic Complete Response
Item
3. patients must be in complete cytogenetic remission.
boolean
C4050364 (UMLS CUI [1])
bcr-abl Transcript Levels Detectable | Molecular Major Response failed | Transcript Levels Increased | Measurement Quantity
Item
4. patients must have detectable bcr-abl transcript levels meeting at least one of the following criteria: 1) patient has never achieved a major molecular response (i.e., never reached levels <0.05%), and transcript levels have shown in at least two consecutive measures separated by at least 1 month to have increased by any value, or
boolean
C0004891 (UMLS CUI [1,1])
C3481430 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
C3830527 (UMLS CUI [1,4])
C4049637 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C3481430 (UMLS CUI [3,1])
C0441889 (UMLS CUI [3,2])
C0205217 (UMLS CUI [3,3])
C0242485 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Molecular Major Response achieved | Transcript Levels Increased | Molecular Major Response lost | Analysis Quantity | bcr-abl Transcript Levels
Item
5. continued from above: 2) achieved a major molecular response that has been lost with an increase in transcript levels by at least 1-log over two consecutive analyses separated by at least 1 month, or 3) bcr-abl transcript levels have reached a plateau defined as a ratio that is not more than 0.25-log (one fourth of a log) lower than the lowest value obtained in the last at least 6 months, with at least 2 values obtained during this period.
boolean
C4049637 (UMLS CUI [1,1])
C1272277 (UMLS CUI [1,2])
C3481430 (UMLS CUI [2,1])
C0441889 (UMLS CUI [2,2])
C0205217 (UMLS CUI [2,3])
C4049637 (UMLS CUI [3,1])
C0745777 (UMLS CUI [3,2])
C0002778 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0004891 (UMLS CUI [5,1])
C3481430 (UMLS CUI [5,2])
C0441889 (UMLS CUI [5,3])
imatinib | Therapy interrupted Absent
Item
6. patients must not have had a continuous interruption of imatinib therapy of greater than 14 days or any interruptions totaling 6 weeks within the 6 months prior to enrollment.
boolean
C0935989 (UMLS CUI [1])
C1710384 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
HLA-A2 Positive | Allele Quantity
Item
7. patients must be hla-a2 positive at one allele
boolean
C0019733 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0002085 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Informed Consent | Compliance behavior
Item
8. patients must give informed consent and sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
ECOG performance status
Item
9. eastern cooperative oncology group (ecog) performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Organ function | Serum total bilirubin measurement | Creatinine measurement, serum | Alanine aminotransferase measurement
Item
10. adequate organ function defined as: bilirubin <2 times upper limit of normal (uln), creatinine <1.5 times uln, and serum glutamate pyruvate transaminase (sgpt) <2.5 times uln.
boolean
C0678852 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Childbearing Potential Contraceptive methods
Item
11. women of childbearing potential should practice effective methods of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Autoimmune Diseases Evidence Clinical
Item
1. patients with a history or clinical evidence of autoimmune disorders
boolean
C0004364 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Therapeutic immunosuppression | Cyclosporine | FK-506
Item
2. patients receiving immunosuppressive therapy including cyclosporine, or fk506 within 3 months of study entry
boolean
C0021079 (UMLS CUI [1])
C0010592 (UMLS CUI [2])
C0729218 (UMLS CUI [3])
Adrenal Cortex Hormones High dose Chronic | Prednisone | Topical corticosteroids | inhaled steroids
Item
3. chronic use (> 2 weeks) of greater than physiologic doses of corticosteroid agent (dose equivalent to > 10 mg/day of prednisone) within 28 days of the first day of study drug treatment (topical and inhaled corticosteroids are permitted)
boolean
C0001617 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0032952 (UMLS CUI [2])
C0304604 (UMLS CUI [3])
C2065041 (UMLS CUI [4])
Granulocyte-Macrophage Colony-Stimulating Factor | Interferon
Item
4. gm-csf or interferon administration within 1 month of first pr1 injection
boolean
C0079460 (UMLS CUI [1])
C0021747 (UMLS CUI [2])
Investigational New Drugs | Investigational Therapy Adverse effects Patient recovered
Item
5. patients receiving any other investigational agents currently or within the past 4 weeks. patients must have recovered from any adverse effects of investigational therapy.
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C1115804 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
6. patients who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart Disease New York Heart Association Classification
Item
7. patients with clinically significant heart disease (new york heart association (nyha) class iii or iv)
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
c-ANCA positive
Item
8. patients with positive canca
boolean
C0238874 (UMLS CUI [1])
HIV Seropositivity | Acquired Immunodeficiency Syndrome
Item
9. history of hiv positivity or aids
boolean
C0019699 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
Chloroma
Item
10. chloroma at time of study screening
boolean
C0152276 (UMLS CUI [1])
Vaccine Therapy Chronic Myeloid Leukemia
Item
11. prior vaccine therapy for chronic myelogenous leukemia (cml)
boolean
C0042209 (UMLS CUI [1,1])
C0023473 (UMLS CUI [1,2])
Hypersensitivity Montanide ISA 51 VG Adjuvant
Item
12. known allergy to montanide isa-51 vg adjuvant
boolean
C0020517 (UMLS CUI [1,1])
C2827521 (UMLS CUI [1,2])
C0001552 (UMLS CUI [1,3])
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