ID

21429

Beschrijving

Study of AMG 531 to Evaluate the Safety & Efficacy in Patients With Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00299182

Link

https://clinicaltrials.gov/show/NCT00299182

Trefwoorden

Versies (1)
  1. 21-04-17 21-04-17 -
Geüploaded op

21 april 2017

DOI

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Creative Commons BY 4.0
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Eligibility Lymphoma NCT00299182

Engels

Eligibility Lymphoma NCT00299182

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00299182
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with a diagnosis of previously untreated aggressive non-hodgkin's lymphoma, including patients with mantle cell lymphoma, who will be or are receiving treatment with r-hypercvad and r-ara-c/mtx. patients in whom rituximab is not used, due to contraindication, will be eligible. patients whose therapy was switched to (r)hyper-cvad after initial treatment with (r)chop, because of aggressive disease will also be eligible for the study.
Beschrijving

Aggressive non-hodgkin's lymphoma, therapy with r-hypercvad and r-ara-c/mtx, contraindication to rituximab, switch to (r)hyper-CVAD

Datatype

boolean

Alias
UMLS CUI [1]
C1332225
UMLS CUI [2]
C1881081
UMLS CUI [3,1]
C0393022
UMLS CUI [3,2]
C0522473
UMLS CUI [4,1]
C1742845
UMLS CUI [4,2]
C0392747
2. patients age >/= 18 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. karnofsky performance scale >/= 70.
Beschrijving

Karnofsky performance scale

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
4. adequate hematologic (anc >/= 1000/mm(3), platelet count >/= 100,000/mm(3) and hgb >/= 8gm/dl), renal (serum creatinine < 2mg/dl), and hepatic functions (total bilirubin </= 2 times, serum glutamate pyruvate transaminase (sgpt) or serum glutamate oxaloacetate transaminase (sgot) </= 3 times the upper limit of the respective normal range).
Beschrijving

ANC, platelet count, hemoglobin measurement, creatinine measurement, total bilirubin, sgpt

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0019046
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0201913
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201899
5. patients (male and female) with childbearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) must use adequate birth control.
Beschrijving

Contraceptive method

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
6. institutional review board (irb)-approved signed informed consent.
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or lactating women.
Beschrijving

Gynaecological status

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. history of central nervous system (cns) involvement.
Beschrijving

CNS involvement

Datatype

boolean

Alias
UMLS CUI [1]
C0449389
3. co-morbid medical or psychiatric illnesses that preclude treatment with intense dose chemotherapy.
Beschrijving

Comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
4. patients with history of deep vein thrombosis (dvt) or pulmonary embolus.
Beschrijving

Deep vein thrombosis or pulmonary embolus

Datatype

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2]
C0034065
5. history of any platelet disorders including idiopathic thrombocytopenic purpura (itp), thrombotic thrombocytopenic purpura (ttp) or bleeding disorders.
Beschrijving

Platelet or bleeding disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0005818
UMLS CUI [2]
C0005779
6. prior surgery or radiation therapy (rt) within 2 weeks of study entry.
Beschrijving

Prior Surgery or Radiation

Datatype

boolean

Alias
UMLS CUI [1]
C0744961
UMLS CUI [2]
C0279134
7. patients with significant cardiac disease (new york heart association (nyha) class iii or iv), dysrrhythmia, or recent history of myocardial ischemia (mi) or ischemia, transient ischemic attack or cerebrovascular accident (cva) within the previous 6 months of study entry.
Beschrijving

NYHA, arrhythmia, myocardial ischemia, cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0038454
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Similar models

Eligibility Lymphoma NCT00299182

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00299182
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Aggressive non-hodgkin's lymphoma, therapy with r-hypercvad and r-ara-c/mtx, contraindication to rituximab, switch to (r)hyper-CVAD
Item
1. patients with a diagnosis of previously untreated aggressive non-hodgkin's lymphoma, including patients with mantle cell lymphoma, who will be or are receiving treatment with r-hypercvad and r-ara-c/mtx. patients in whom rituximab is not used, due to contraindication, will be eligible. patients whose therapy was switched to (r)hyper-cvad after initial treatment with (r)chop, because of aggressive disease will also be eligible for the study.
boolean
C1332225 (UMLS CUI [1])
C1881081 (UMLS CUI [2])
C0393022 (UMLS CUI [3,1])
C0522473 (UMLS CUI [3,2])
C1742845 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
Age
Item
2. patients age >/= 18 years.
boolean
C0001779 (UMLS CUI [1])
Karnofsky performance scale
Item
3. karnofsky performance scale >/= 70.
boolean
C0206065 (UMLS CUI [1])
ANC, platelet count, hemoglobin measurement, creatinine measurement, total bilirubin, sgpt
Item
4. adequate hematologic (anc >/= 1000/mm(3), platelet count >/= 100,000/mm(3) and hgb >/= 8gm/dl), renal (serum creatinine < 2mg/dl), and hepatic functions (total bilirubin </= 2 times, serum glutamate pyruvate transaminase (sgpt) or serum glutamate oxaloacetate transaminase (sgot) </= 3 times the upper limit of the respective normal range).
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0201913 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
Contraceptive method
Item
5. patients (male and female) with childbearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) must use adequate birth control.
boolean
C0700589 (UMLS CUI [1])
Informed consent
Item
6. institutional review board (irb)-approved signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gynaecological status
Item
1. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
CNS involvement
Item
2. history of central nervous system (cns) involvement.
boolean
C0449389 (UMLS CUI [1])
Comorbidity
Item
3. co-morbid medical or psychiatric illnesses that preclude treatment with intense dose chemotherapy.
boolean
C0009488 (UMLS CUI [1])
Deep vein thrombosis or pulmonary embolus
Item
4. patients with history of deep vein thrombosis (dvt) or pulmonary embolus.
boolean
C0149871 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
Platelet or bleeding disorders
Item
5. history of any platelet disorders including idiopathic thrombocytopenic purpura (itp), thrombotic thrombocytopenic purpura (ttp) or bleeding disorders.
boolean
C0005818 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
Prior Surgery or Radiation
Item
6. prior surgery or radiation therapy (rt) within 2 weeks of study entry.
boolean
C0744961 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
NYHA, arrhythmia, myocardial ischemia, cerebrovascular accident
Item
7. patients with significant cardiac disease (new york heart association (nyha) class iii or iv), dysrrhythmia, or recent history of myocardial ischemia (mi) or ischemia, transient ischemic attack or cerebrovascular accident (cva) within the previous 6 months of study entry.
boolean
C1275491 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
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