ID

17998

Beschrijving

Rituximab and Combination Chemotherapy Followed By Thalidomide in Treating Patients With Previously Untreated Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00450801

Link

https://clinicaltrials.gov/show/NCT00450801

Trefwoorden

Versies (1)
  1. 13-10-16 13-10-16 -
Geüploaded op

13 oktober 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00450801

Engels

Eligibility Lymphoma NCT00450801

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00450801
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
disease characteristics:
Beschrijving

disease characteristic

Datatype

boolean

Alias
UMLS CUI [1]
C0599878
histologically confirmed mantle cell lymphoma
Beschrijving

Mantle cell lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0334634
all stages allowed
Beschrijving

TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
previously untreated disease
Beschrijving

Disease untreated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332155
measurable or evaluable disease
Beschrijving

Measurable Disease | Evaluable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
no cns involvement
Beschrijving

Central Nervous System Involvement

Datatype

boolean

Alias
UMLS CUI [1]
C4050309
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 6 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
bilirubin < 3 mg/dl
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
sgot and/or sgpt < 2.5 times upper limit of normal (unless due to lymphomatous involvement)
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Lymphomatous nodal involvement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0441949
creatinine < 1.5 mg/dl
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
not pregnant or nursing
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
negative pregnancy test
Beschrijving

Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective double-method contraception during and for ≥ 4 weeks after completion of study treatment (if receiving thalidomide)
Beschrijving

Fertility Contraceptive methods | Fertility Contraception, Barrier | Thalidomide

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0015895
UMLS CUI [2,2]
C0004764
UMLS CUI [3]
C0039736
no other concurrent active malignancies, except for in situ carcinoma of the cervix or basal cell carcinoma of the skin
Beschrijving

Malignant Neoplasms | Carcinoma in situ of uterine cervix | Basal cell carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0851140
UMLS CUI [3]
C0007117
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
grade 3-4 cardiac failure
Beschrijving

Heart failure | New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C1275491
lvef that is less than ≥ 50%
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
psychological, familial, sociological, or geographical conditions that would preclude study compliance
Beschrijving

Condition Excludes Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
known history of hiv or aids
Beschrijving

HIV | Acquired Immunodeficiency Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0001175
hepatitis or hepatitis b virus infection
Beschrijving

Hepatitis | Hepatitis B

Datatype

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0019163
prior concurrent therapy:
Beschrijving

Prior Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
any prior chemotherapy, immunotherapy, or radiotherapy for this lymphoma
Beschrijving

Prior Chemotherapy Mantle cell lymphoma | Prior Immunotherapy Mantle cell lymphoma | prior radiation therapy Mantle cell lymphoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0334634
UMLS CUI [2,1]
C1514461
UMLS CUI [2,2]
C0334634
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0334634
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Similar models

Eligibility Lymphoma NCT00450801

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00450801
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
disease characteristic
Item
disease characteristics:
boolean
C0599878 (UMLS CUI [1])
Mantle cell lymphoma
Item
histologically confirmed mantle cell lymphoma
boolean
C0334634 (UMLS CUI [1])
TNM clinical staging
Item
all stages allowed
boolean
C3258246 (UMLS CUI [1])
Disease untreated
Item
previously untreated disease
boolean
C0012634 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Measurable Disease | Evaluable Disease
Item
measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Central Nervous System Involvement
Item
no cns involvement
boolean
C4050309 (UMLS CUI [1])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin < 3 mg/dl
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Lymphomatous nodal involvement
Item
sgot and/or sgpt < 2.5 times upper limit of normal (unless due to lymphomatous involvement)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0441949 (UMLS CUI [3])
Creatinine measurement, serum
Item
creatinine < 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods | Fertility Contraception, Barrier | Thalidomide
Item
fertile patients must use effective double-method contraception during and for ≥ 4 weeks after completion of study treatment (if receiving thalidomide)
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015895 (UMLS CUI [2,1])
C0004764 (UMLS CUI [2,2])
C0039736 (UMLS CUI [3])
Malignant Neoplasms | Carcinoma in situ of uterine cervix | Basal cell carcinoma
Item
no other concurrent active malignancies, except for in situ carcinoma of the cervix or basal cell carcinoma of the skin
boolean
C0006826 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Heart failure | New York Heart Association Classification
Item
grade 3-4 cardiac failure
boolean
C0018801 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Left ventricular ejection fraction
Item
lvef that is less than ≥ 50%
boolean
C0428772 (UMLS CUI [1])
Condition Excludes Protocol Compliance
Item
psychological, familial, sociological, or geographical conditions that would preclude study compliance
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
HIV | Acquired Immunodeficiency Syndrome
Item
known history of hiv or aids
boolean
C0019682 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
Hepatitis | Hepatitis B
Item
hepatitis or hepatitis b virus infection
boolean
C0019158 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
Prior Chemotherapy Mantle cell lymphoma | Prior Immunotherapy Mantle cell lymphoma | prior radiation therapy Mantle cell lymphoma
Item
any prior chemotherapy, immunotherapy, or radiotherapy for this lymphoma
boolean
C1514457 (UMLS CUI [1,1])
C0334634 (UMLS CUI [1,2])
C1514461 (UMLS CUI [2,1])
C0334634 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3,1])
C0334634 (UMLS CUI [3,2])
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