ID

41214

Beschreibung

Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01473628

Link

https://clinicaltrials.gov/show/NCT01473628

Stichworte

Versionen (2)
  1. 16.07.20 16.07.20 -
  2. 16.07.20 16.07.20 -
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See clinicaltrials.gov

Hochgeladen am

16. Juli 2020

DOI

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Creative Commons BY 4.0
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Eligibility Lymphoma NCT01473628

Englisch

Eligibility Lymphoma NCT01473628

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01473628
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. newly diagnosed patients with stage i and ii follicular lymphoma, pathologically confirmed at mdacc to be grade 1 or 2.
Beschreibung

Follicular Lymphoma Ann Arbor lymphoma staging system | Follicular Lymphoma Grade

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
UMLS CUI [2,1]
C0024301
UMLS CUI [2,2]
C0441800
2. prophylactic use of lamivudine in patients that have antibody +, but no active infection will be up to the treating physician.
Beschreibung

Prophylactic treatment Lamivudine | Antibody test positive | Communicable Disease Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0199176
UMLS CUI [1,2]
C0209738
UMLS CUI [2]
C0741132
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0332197
3. >/= 18 at the time of signing the informed consent form
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. patients are required to have adequate bone marrow reserve as indicated: * absolute neutrophil count (anc) /=> 1000/mm^3 *platelets >/= 80,000/mm^3, *hemoglobin >/= 8g/dl. these values must be obtained within two weeks before protocol entry.
Beschreibung

Bone Marrow Mature Neutrophils Present | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C1708947
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
5. patients must have adequate liver function as indicated by: *bilirubin </= 1.5 times the upper limit of normal (uln), *alanine transaminase (alt) </= 2 times the (uln) or aspartate transaminase (ast) </= 2 times the uln, these values must be obtained within two weeks before protocol entry. performance status >/= 2
Beschreibung

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
6. patients are required to have adequate renal function as indicated by a serum creatinine </= 2.5 mg/dl. this value must be obtained within two weeks before protocol entry.
Beschreibung

Renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
7. no prior known allergic reaction to monoclonal antibodies.
Beschreibung

Allergic Reaction Absent Monoclonal Antibodies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0003250
8. male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.
Beschreibung

Gender Barrier Contraception | Gender Sexual Abstinence Coitus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0036899
UMLS CUI [2,3]
C0009253
9. female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses > two years or surgically sterilized).
Beschreibung

Gender Barrier Contraception Quantity | Gender Sexual Abstinence Coitus | Postmenopausal state | Female Sterilization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0036899
UMLS CUI [2,3]
C0009253
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0015787
10. female patients of childbearing potential must have a negative serum pregnancy test (b hcg) within 72 hours of receiving the first dose of rituximab
Beschreibung

Childbearing Potential Serum pregnancy test (B-HCG) Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
11. patients must have the ability able to give informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with active hepatitis b and/or hepatitis c infection.
Beschreibung

Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
2. patients with known hiv infection
Beschreibung

HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
3. patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
Beschreibung

Communicable Diseases Requirement Anti-infective therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1141958
4. patients who had previous radiation dose to the site of the current primary disease, which would lead to violation of known radiation tolerance limit of that particular site if treated again.
Beschreibung

Prior Radiation Therapy Site Disease Current

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0521116
5. patients with pre-existing cardiovascular disease requiring ongoing treatment. this includes: a. congestive heart failure iii/iv as defined by new york heart association (nyha) b. uncontrolled cardiac arrhythmia, c. unstable angina pectoris, d. recent mi (within 6 months).
Beschreibung

Cardiovascular Disease Pre-existing Treatment required for | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Uncontrolled | Angina, Unstable | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C0332121
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0027051
6. patients who are pregnant or breast-feeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. patient with concurrent use of complementary or alternative medicines.
Beschreibung

Pharmaceutical Preparations Alternative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1523987
8. patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.
Beschreibung

Mental disorders Limiting Medication Compliance | Social situation Limiting Medication Compliance | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C3489773
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C3489773
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0748872
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0525058
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Ähnliche Modelle

Eligibility Lymphoma NCT01473628

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01473628
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Follicular Lymphoma Ann Arbor lymphoma staging system | Follicular Lymphoma Grade
Item
1. newly diagnosed patients with stage i and ii follicular lymphoma, pathologically confirmed at mdacc to be grade 1 or 2.
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C0024301 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
Prophylactic treatment Lamivudine | Antibody test positive | Communicable Disease Absent
Item
2. prophylactic use of lamivudine in patients that have antibody +, but no active infection will be up to the treating physician.
boolean
C0199176 (UMLS CUI [1,1])
C0209738 (UMLS CUI [1,2])
C0741132 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Age
Item
3. >/= 18 at the time of signing the informed consent form
boolean
C0001779 (UMLS CUI [1])
Bone Marrow Mature Neutrophils Present | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
4. patients are required to have adequate bone marrow reserve as indicated: * absolute neutrophil count (anc) /=> 1000/mm^3 *platelets >/= 80,000/mm^3, *hemoglobin >/= 8g/dl. these values must be obtained within two weeks before protocol entry.
boolean
C0005953 (UMLS CUI [1,1])
C1708947 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
5. patients must have adequate liver function as indicated by: *bilirubin </= 1.5 times the upper limit of normal (uln), *alanine transaminase (alt) </= 2 times the (uln) or aspartate transaminase (ast) </= 2 times the uln, these values must be obtained within two weeks before protocol entry. performance status >/= 2
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
Renal function | Creatinine measurement, serum
Item
6. patients are required to have adequate renal function as indicated by a serum creatinine </= 2.5 mg/dl. this value must be obtained within two weeks before protocol entry.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Allergic Reaction Absent Monoclonal Antibodies
Item
7. no prior known allergic reaction to monoclonal antibodies.
boolean
C1527304 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0003250 (UMLS CUI [1,3])
Gender Barrier Contraception | Gender Sexual Abstinence Coitus
Item
8. male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C0009253 (UMLS CUI [2,3])
Gender Barrier Contraception Quantity | Gender Sexual Abstinence Coitus | Postmenopausal state | Female Sterilization
Item
9. female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses > two years or surgically sterilized).
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C0009253 (UMLS CUI [2,3])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
10. female patients of childbearing potential must have a negative serum pregnancy test (b hcg) within 72 hours of receiving the first dose of rituximab
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Informed Consent
Item
11. patients must have the ability able to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hepatitis B | Hepatitis C
Item
1. patients with active hepatitis b and/or hepatitis c infection.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
HIV Infection
Item
2. patients with known hiv infection
boolean
C0019693 (UMLS CUI [1])
Communicable Diseases Requirement Anti-infective therapy
Item
3. patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1141958 (UMLS CUI [1,3])
Prior Radiation Therapy Site Disease Current
Item
4. patients who had previous radiation dose to the site of the current primary disease, which would lead to violation of known radiation tolerance limit of that particular site if treated again.
boolean
C0279134 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
Cardiovascular Disease Pre-existing Treatment required for | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Uncontrolled | Angina, Unstable | Myocardial Infarction
Item
5. patients with pre-existing cardiovascular disease requiring ongoing treatment. this includes: a. congestive heart failure iii/iv as defined by new york heart association (nyha) b. uncontrolled cardiac arrhythmia, c. unstable angina pectoris, d. recent mi (within 6 months).
boolean
C0007222 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
6. patients who are pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pharmaceutical Preparations Alternative
Item
7. patient with concurrent use of complementary or alternative medicines.
boolean
C0013227 (UMLS CUI [1,1])
C1523987 (UMLS CUI [1,2])
Mental disorders Limiting Medication Compliance | Social situation Limiting Medication Compliance | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
8. patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C3489773 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C3489773 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0748872 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
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