ID

24684

Description

Peptide Vaccinations to Treat Patients With Low-Risk Myeloid Cancers; ODM derived from: https://clinicaltrials.gov/show/NCT00488592

Link

https://clinicaltrials.gov/show/NCT00488592

Keywords

Versions (1)
  1. 8/13/17 8/13/17 -
Uploaded on

August 13, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Myelodysplastic Syndrome (MDS) NCT00488592

English

Eligibility Myelodysplastic Syndrome (MDS) NCT00488592

1 forms  
Criteria
Description

Criteria

diagnosed with mds (b subtypes refractory anemia (ra), refractory anemia with ring sideroblasts (rars) -low risk) (mds with 5q- must have failed lenalidomide or been ineligible to receive it)
Description

MYELODYSPLASTIC SYNDROME | Subtype Refractory anemia | Subtype Refractory anemia with ringed sideroblasts Low Risk | 5q minus syndrome | Lenalidomide failed | Patient Ineligible Lenalidomide

Data type

boolean

Alias
UMLS CUI [1]
C3463824
UMLS CUI [2,1]
C0449560
UMLS CUI [2,2]
C0002893
UMLS CUI [3,1]
C0449560
UMLS CUI [3,2]
C1264195
UMLS CUI [3,3]
C3538919
UMLS CUI [4]
C1292779
UMLS CUI [5,1]
C1144149
UMLS CUI [5,2]
C0231175
UMLS CUI [6,1]
C0030705
UMLS CUI [6,2]
C1512714
UMLS CUI [6,3]
C1144149
diagnosed with aml and in complete remission within 5 years of treatment with less than 5% marrow blasts
Description

Acute myeloid leukemia in remission | Blasts Bone marrow Percentage

Data type

boolean

Alias
UMLS CUI [1]
C0153886
UMLS CUI [2,1]
C1982687
UMLS CUI [2,2]
C0439165
diagnosed with cml in chronic phase
Description

Leukemia, Myeloid, Chronic-Phase

Data type

boolean

Alias
UMLS CUI [1]
C0023474
unsuitable for stem cell transplantation (sct) (age over sixty or unavailability of a fully-matched donor)
Description

Patient Inappropriate Stem cell transplantation | Age Relationship | Tissue Donor HLA Matched Unavailable

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1504389
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C0439849
UMLS CUI [3,1]
C0040288
UMLS CUI [3,2]
C1548978
UMLS CUI [3,3]
C0686905
made an informed decision not to undergo the transplant procedure
Description

Transplantation Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C1705116
are between 6 months 3 years following allogeneic sct and fulfill the following criteria:
Description

Allogeneic Stem Cell Transplantation Status post | Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C2242529
UMLS CUI [1,2]
C0231290
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
100% donor engraftment,
Description

Tissue Donor Graft acceptance Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0040288
UMLS CUI [1,2]
C0301944
UMLS CUI [1,3]
C0439165
less than 5% blasts in marrow
Description

Blasts Bone marrow Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1982687
UMLS CUI [1,2]
C0439165
normal marrow cellularity
Description

Bone marrow cellularity

Data type

boolean

Alias
UMLS CUI [1]
C1561532
human leukocyte antigen (hla-a020 1) positive at one allele
Description

HLA-A0201 Positive Allele Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1097566
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0002085
UMLS CUI [1,4]
C1265611
ages 18-85 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
off all lympho-ablative chemotherapeutic agents
Description

Lymph node Ablation | Antineoplastic Agents Discontinued

Data type

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0547070
UMLS CUI [2,1]
C0003392
UMLS CUI [2,2]
C1444662
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypoplastic mds
Description

MYELODYSPLASTIC SYNDROME Hypoplastic

Data type

boolean

Alias
UMLS CUI [1,1]
C3463824
UMLS CUI [1,2]
C0543481
relapsed aml
Description

Recurrent adult acute myeloid leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0278780
cml in accelerated phase or blast crisis
Description

Leukemia, Myeloid, Accelerated Phase | Chronic myelogenous leukemia with crisis of blast cells

Data type

boolean

Alias
UMLS CUI [1]
C0023472
UMLS CUI [2]
C2861579
hypocellular bone marrow (less than 20%)
Description

Bone marrow depression Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0151773
UMLS CUI [1,2]
C0439165
history of wegener's granulomatosis
Description

Granulomatosis with polyangiitis

Data type

boolean

Alias
UMLS CUI [1]
C3495801
serologic antibody against proteinase-3 (anca positive)
Description

Proteinase-3 antibody Serologic | ANCA positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0443910
UMLS CUI [1,2]
C0205473
UMLS CUI [2]
C0238874
previous allergic reaction to montanide adjuvant
Description

Allergic Reaction Montanide ISA 51 Adjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1311732
UMLS CUI [1,3]
C0001552
positive test for hiv
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
treatment with systemic corticosteroids or immunosuppressants within 14 days prior to study entry
Description

CORTICOSTEROIDS FOR SYSTEMIC USE | Immunosuppressive Agents Systemic

Data type

boolean

Alias
UMLS CUI [1]
C3653708
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C0205373
co-morbidity of such severity that it would preclude the patient's ability to tolerate protocol therapy
Description

Comorbidity Severe | Investigational Therapy Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C1299582
predicted survival less than 28 days
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
pregnant or breast feeding (all female patients must have a urine pregnancy test within 1 week prior to vaccine administration)
Description

Pregnancy | Breast Feeding | Gender Urine pregnancy test | Administration of vaccine

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0430056
UMLS CUI [4]
C2368628
unwilling to practice abstinence or effective contraception (men and women) during the study period.
Description

Sexual Abstinence Unwilling | Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0036899
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
enrolled in another drug or vaccine clinical trial during the study period
Description

Study Subject Participation Status | Investigational New Drugs | Vaccines

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0042210
inability to comprehend the investigational nature of the study and provide informed consent
Description

Study Protocol Comprehension Unable | Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Myelodysplastic Syndrome (MDS) NCT00488592

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
MYELODYSPLASTIC SYNDROME | Subtype Refractory anemia | Subtype Refractory anemia with ringed sideroblasts Low Risk | 5q minus syndrome | Lenalidomide failed | Patient Ineligible Lenalidomide
Item
diagnosed with mds (b subtypes refractory anemia (ra), refractory anemia with ring sideroblasts (rars) -low risk) (mds with 5q- must have failed lenalidomide or been ineligible to receive it)
boolean
C3463824 (UMLS CUI [1])
C0449560 (UMLS CUI [2,1])
C0002893 (UMLS CUI [2,2])
C0449560 (UMLS CUI [3,1])
C1264195 (UMLS CUI [3,2])
C3538919 (UMLS CUI [3,3])
C1292779 (UMLS CUI [4])
C1144149 (UMLS CUI [5,1])
C0231175 (UMLS CUI [5,2])
C0030705 (UMLS CUI [6,1])
C1512714 (UMLS CUI [6,2])
C1144149 (UMLS CUI [6,3])
Acute myeloid leukemia in remission | Blasts Bone marrow Percentage
Item
diagnosed with aml and in complete remission within 5 years of treatment with less than 5% marrow blasts
boolean
C0153886 (UMLS CUI [1])
C1982687 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Leukemia, Myeloid, Chronic-Phase
Item
diagnosed with cml in chronic phase
boolean
C0023474 (UMLS CUI [1])
Patient Inappropriate Stem cell transplantation | Age Relationship | Tissue Donor HLA Matched Unavailable
Item
unsuitable for stem cell transplantation (sct) (age over sixty or unavailability of a fully-matched donor)
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1504389 (UMLS CUI [1,3])
C0001779 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0040288 (UMLS CUI [3,1])
C1548978 (UMLS CUI [3,2])
C0686905 (UMLS CUI [3,3])
Transplantation Refused
Item
made an informed decision not to undergo the transplant procedure
boolean
C0040732 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Allogeneic Stem Cell Transplantation Status post | Criteria Fulfill
Item
are between 6 months 3 years following allogeneic sct and fulfill the following criteria:
boolean
C2242529 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Tissue Donor Graft acceptance Percentage
Item
100% donor engraftment,
boolean
C0040288 (UMLS CUI [1,1])
C0301944 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Blasts Bone marrow Percentage
Item
less than 5% blasts in marrow
boolean
C1982687 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Bone marrow cellularity
Item
normal marrow cellularity
boolean
C1561532 (UMLS CUI [1])
HLA-A0201 Positive Allele Quantity
Item
human leukocyte antigen (hla-a020 1) positive at one allele
boolean
C1097566 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0002085 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Age
Item
ages 18-85 years old
boolean
C0001779 (UMLS CUI [1])
Lymph node Ablation | Antineoplastic Agents Discontinued
Item
off all lympho-ablative chemotherapeutic agents
boolean
C0024204 (UMLS CUI [1,1])
C0547070 (UMLS CUI [1,2])
C0003392 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
MYELODYSPLASTIC SYNDROME Hypoplastic
Item
hypoplastic mds
boolean
C3463824 (UMLS CUI [1,1])
C0543481 (UMLS CUI [1,2])
Recurrent adult acute myeloid leukemia
Item
relapsed aml
boolean
C0278780 (UMLS CUI [1])
Leukemia, Myeloid, Accelerated Phase | Chronic myelogenous leukemia with crisis of blast cells
Item
cml in accelerated phase or blast crisis
boolean
C0023472 (UMLS CUI [1])
C2861579 (UMLS CUI [2])
Bone marrow depression Percentage
Item
hypocellular bone marrow (less than 20%)
boolean
C0151773 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Granulomatosis with polyangiitis
Item
history of wegener's granulomatosis
boolean
C3495801 (UMLS CUI [1])
Proteinase-3 antibody Serologic | ANCA positive
Item
serologic antibody against proteinase-3 (anca positive)
boolean
C0443910 (UMLS CUI [1,1])
C0205473 (UMLS CUI [1,2])
C0238874 (UMLS CUI [2])
Allergic Reaction Montanide ISA 51 Adjuvant
Item
previous allergic reaction to montanide adjuvant
boolean
C1527304 (UMLS CUI [1,1])
C1311732 (UMLS CUI [1,2])
C0001552 (UMLS CUI [1,3])
HIV Seropositivity
Item
positive test for hiv
boolean
C0019699 (UMLS CUI [1])
CORTICOSTEROIDS FOR SYSTEMIC USE | Immunosuppressive Agents Systemic
Item
treatment with systemic corticosteroids or immunosuppressants within 14 days prior to study entry
boolean
C3653708 (UMLS CUI [1])
C0021081 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
Comorbidity Severe | Investigational Therapy Receive Unable
Item
co-morbidity of such severity that it would preclude the patient's ability to tolerate protocol therapy
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Life Expectancy
Item
predicted survival less than 28 days
boolean
C0023671 (UMLS CUI [1])
Pregnancy | Breast Feeding | Gender Urine pregnancy test | Administration of vaccine
Item
pregnant or breast feeding (all female patients must have a urine pregnancy test within 1 week prior to vaccine administration)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0430056 (UMLS CUI [3,2])
C2368628 (UMLS CUI [4])
Sexual Abstinence Unwilling | Contraceptive methods Unwilling
Item
unwilling to practice abstinence or effective contraception (men and women) during the study period.
boolean
C0036899 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Study Subject Participation Status | Investigational New Drugs | Vaccines
Item
enrolled in another drug or vaccine clinical trial during the study period
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0042210 (UMLS CUI [3])
Study Protocol Comprehension Unable | Informed Consent Unable
Item
inability to comprehend the investigational nature of the study and provide informed consent
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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