ID

30184

Beschrijving

JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00860522

Link

https://clinicaltrials.gov/show/NCT00860522

Trefwoorden

Versies (1)
  1. 18-05-18 18-05-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

18 mei 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Leukemia NCT00860522

Engels

Eligibility Leukemia NCT00860522

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00860522
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histologically or cytologically documented relapsed or refractory acute leukemia
Beschrijving

Acute leukemia in relapse | Acute leukemia refractory

Datatype

boolean

Alias
UMLS CUI [1]
C2367453
UMLS CUI [2,1]
C0085669
UMLS CUI [2,2]
C0205269
unlikely to benefit from standard therapy in the opinion of the investigator or refuse standard therapy
Beschrijving

Standard therapy benefit Unlikely | Standard therapy Refused

Datatype

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0814225
UMLS CUI [1,3]
C0750558
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C1705116
ecog performance status 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate renal and hepatic function
Beschrijving

Renal function | Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
no hematologic criteria for wbc, hbg or platelets
Beschrijving

Criteria Hematologic Absent | White Blood Cell Count procedure | Hemoglobin | Blood Platelets

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0205488
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0019046
UMLS CUI [4]
C0005821
negative virology screen for hiv, hepatitis b surface antigen & hepatitis c
Beschrijving

HIV negative | Hepatitis B surface antigen negative | Hepatitis C test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0481430
UMLS CUI [2]
C0919711
UMLS CUI [3]
C1619717
female patients of childbearing potential must have a negative serum pregnancy test
Beschrijving

Childbearing Potential Serum pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
male & female patients must agree to use a medically acceptable barrier and/or chemical contraceptive method during the study and for a minimum of 3 months afte the last dose of study treatment.
Beschrijving

Gender | Agreement Barrier Contraception | Agreement Chemical contraception

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0680240
UMLS CUI [2,2]
C0004764
UMLS CUI [3,1]
C0680240
UMLS CUI [3,2]
C1868784
patients post blood or marrow transplant should demonstrate a circulating cd8 count of at lest 200 cells/ul
Beschrijving

Status post Blood Transplantation | Status post Bone Marrow Transplantation | Absolute CD8 count Circulating blood

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040732
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0005961
UMLS CUI [3,1]
C1277777
UMLS CUI [3,2]
C0440738
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
active cns leukemia
Beschrijving

Central nervous system leukaemia

Datatype

boolean

Alias
UMLS CUI [1]
C1332884
current concomitant chemotherapy, radiation therapy or immunotherapy
Beschrijving

Chemotherapy | Therapeutic radiology procedure | Immunotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
receipt of any investigational agent within 28 days of first dose of jvrs-100
Beschrijving

Investigational New Drugs | Relationship JVRS-100

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C2830046
persistent clinically significant toxicity from prior anticancer therapy that is > grade 2 (nci ctcae v3.0)
Beschrijving

Toxicity persistent CTCAE Grades | Etiology Cancer treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0205322
UMLS CUI [1,3]
C1516728
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0920425
bone marrow or stem cell transplant within 3 months prior to first dose of jvrs-100
Beschrijving

Bone Marrow Transplantation | Stem cell transplant | Relationship JVRS-100

Datatype

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C1504389
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C2830046
chronic administration of immunosuppressive agents within 14 days of first dose of jvrs-100. use of inhaled steroids, nasal sprays, eye drops, and topical creams for small body areas is allowed.
Beschrijving

Immunosuppressive Agents chronic | Relationship JVRS-100 | Inhaled steroids allowed | Nasal Sprays allowed | Eye Drops allowed | Topical Cream allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C2830046
UMLS CUI [3,1]
C2065041
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C2608293
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C0015399
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C0991551
UMLS CUI [6,2]
C0683607
pregnant or lactating
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of prior malignancy other than leukemia within the past 5 years, excluding basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
Beschrijving

Cancer Other | Exception Leukemia | Basal cell carcinoma Excluded | Squamous cell carcinoma of skin Excluded | Carcinoma in situ of uterine cervix Excluded

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0023418
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C0332196
UMLS CUI [4,1]
C0553723
UMLS CUI [4,2]
C0332196
UMLS CUI [5,1]
C0851140
UMLS CUI [5,2]
C0332196
patients with a systemic fungal, bacterial, viral, or other infection not controlled
Beschrijving

Systemic mycosis | Bacterial Infection Systemic | Virus Disease Systemic

Datatype

boolean

Alias
UMLS CUI [1]
C0553576
UMLS CUI [2,1]
C0004623
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C0042769
UMLS CUI [3,2]
C0205373
any condition which, in the opinion of the investigator, would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
Beschrijving

Condition compromises Patient safety | Condition compromises Compliance behavior | Condition Interferes with Informed Consent | Condition Interferes with Study Subject Participation Status | Condition Interferes with Follow-up | Condition Interferes with Interpretation Research results

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1321605
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C3274571
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0459471
UMLS CUI [6,4]
C0683954
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Similar models

Eligibility Leukemia NCT00860522

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00860522
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age
boolean
C0001779 (UMLS CUI [1])
Acute leukemia in relapse | Acute leukemia refractory
Item
histologically or cytologically documented relapsed or refractory acute leukemia
boolean
C2367453 (UMLS CUI [1])
C0085669 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Standard therapy benefit Unlikely | Standard therapy Refused
Item
unlikely to benefit from standard therapy in the opinion of the investigator or refuse standard therapy
boolean
C2936643 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C0750558 (UMLS CUI [1,3])
C2936643 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Renal function | Liver function
Item
adequate renal and hepatic function
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Criteria Hematologic Absent | White Blood Cell Count procedure | Hemoglobin | Blood Platelets
Item
no hematologic criteria for wbc, hbg or platelets
boolean
C0243161 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0023508 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
C0005821 (UMLS CUI [4])
HIV negative | Hepatitis B surface antigen negative | Hepatitis C test negative
Item
negative virology screen for hiv, hepatitis b surface antigen & hepatitis c
boolean
C0481430 (UMLS CUI [1])
C0919711 (UMLS CUI [2])
C1619717 (UMLS CUI [3])
Childbearing Potential Serum pregnancy test negative
Item
female patients of childbearing potential must have a negative serum pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Gender | Agreement Barrier Contraception | Agreement Chemical contraception
Item
male & female patients must agree to use a medically acceptable barrier and/or chemical contraceptive method during the study and for a minimum of 3 months afte the last dose of study treatment.
boolean
C0079399 (UMLS CUI [1])
C0680240 (UMLS CUI [2,1])
C0004764 (UMLS CUI [2,2])
C0680240 (UMLS CUI [3,1])
C1868784 (UMLS CUI [3,2])
Status post Blood Transplantation | Status post Bone Marrow Transplantation | Absolute CD8 count Circulating blood
Item
patients post blood or marrow transplant should demonstrate a circulating cd8 count of at lest 200 cells/ul
boolean
C0231290 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0005961 (UMLS CUI [2,2])
C1277777 (UMLS CUI [3,1])
C0440738 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Central nervous system leukaemia
Item
active cns leukemia
boolean
C1332884 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy
Item
current concomitant chemotherapy, radiation therapy or immunotherapy
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
Investigational New Drugs | Relationship JVRS-100
Item
receipt of any investigational agent within 28 days of first dose of jvrs-100
boolean
C0013230 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C2830046 (UMLS CUI [2,2])
Toxicity persistent CTCAE Grades | Etiology Cancer treatment
Item
persistent clinically significant toxicity from prior anticancer therapy that is > grade 2 (nci ctcae v3.0)
boolean
C0600688 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
Bone Marrow Transplantation | Stem cell transplant | Relationship JVRS-100
Item
bone marrow or stem cell transplant within 3 months prior to first dose of jvrs-100
boolean
C0005961 (UMLS CUI [1])
C1504389 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C2830046 (UMLS CUI [3,2])
Immunosuppressive Agents chronic | Relationship JVRS-100 | Inhaled steroids allowed | Nasal Sprays allowed | Eye Drops allowed | Topical Cream allowed
Item
chronic administration of immunosuppressive agents within 14 days of first dose of jvrs-100. use of inhaled steroids, nasal sprays, eye drops, and topical creams for small body areas is allowed.
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C2830046 (UMLS CUI [2,2])
C2065041 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C2608293 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0015399 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0991551 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other | Exception Leukemia | Basal cell carcinoma Excluded | Squamous cell carcinoma of skin Excluded | Carcinoma in situ of uterine cervix Excluded
Item
history of prior malignancy other than leukemia within the past 5 years, excluding basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0023418 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0553723 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0851140 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
Systemic mycosis | Bacterial Infection Systemic | Virus Disease Systemic
Item
patients with a systemic fungal, bacterial, viral, or other infection not controlled
boolean
C0553576 (UMLS CUI [1])
C0004623 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0042769 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
Condition compromises Patient safety | Condition compromises Compliance behavior | Condition Interferes with Informed Consent | Condition Interferes with Study Subject Participation Status | Condition Interferes with Follow-up | Condition Interferes with Interpretation Research results
Item
any condition which, in the opinion of the investigator, would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C3274571 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0459471 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
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