ID

30398

Description

Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00878254

Link

https://clinicaltrials.gov/show/NCT00878254

Keywords

Versions (1)
  1. 6/2/18 6/2/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 2, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00878254

English

Eligibility Lymphoma NCT00878254

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00878254
Criteria
Description

Criteria

histologically confirmed mantle cell lymphoma
Description

Mantle cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0334634
previously untreated disease
Description

Disease untreated

Data type

boolean

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

Measurable Disease | Evaluable Disease

Data type

boolean

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

Exclusion Central Nervous System Involvement

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C4050309
patient characteristics:
Description

Client Characteristics

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Life Expectancy

Data type

boolean

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

Serum total bilirubin measurement

Data type

boolean

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

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Exception Etiology Lymphomatous nodal involvement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0015127
UMLS CUI [3,3]
C0441949
serum creatinine < 1.5 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

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

Pregnancy Absent | Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
negative pregnancy test
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no grade 3-4 cardiac failure
Description

Exclusion Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C1275491
lvef ≥ 50%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
no known history of hiv or aids
Description

Exclusion Criteria | HIV Infection | Acquired Immunodeficiency Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0001175
no hepatitis or hepatitis b virus infection
Description

Exclusion Criteria | Hepatitis | Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0019163
no other concurrent active malignancy, except carcinoma in situ of the cervix and basal cell carcinoma of the skin
Description

Exclusion Cancer Other | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
no psychological, familial, sociological, or geographical conditions that would prohibit treatment and/or medical follow-up required to comply with study protocol
Description

Exclusion Criteria | Mental condition Preventing Protocol Compliance | Condition Familial Preventing Protocol Compliance | Sociological Factors Preventing Protocol Compliance | Geographic Factors Preventing Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0241888
UMLS CUI [3,3]
C1292733
UMLS CUI [3,4]
C0525058
UMLS CUI [4,1]
C3850138
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0017444
UMLS CUI [5,2]
C1292733
UMLS CUI [5,3]
C0525058
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
no prior chemotherapy, immunotherapy, or radiotherapy for this lymphoma
Description

Exclusion Criteria | Chemotherapy Lymphoma | Immunotherapy Lymphoma | Therapeutic radiology procedure Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0024299
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0024299
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0024299
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Similar models

Eligibility Lymphoma NCT00878254

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00878254
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Mantle cell lymphoma
Item
histologically confirmed mantle cell lymphoma
boolean
C0334634 (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])
Exclusion Central Nervous System Involvement
Item
no cns involvement
boolean
C2828389 (UMLS CUI [1,1])
C4050309 (UMLS CUI [1,2])
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 | Exception Etiology Lymphomatous nodal involvement
Item
sgot and sgpt < 2.5 times upper limit of normal (unless due to lymphomatous involvement)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0015127 (UMLS CUI [3,2])
C0441949 (UMLS CUI [3,3])
Creatinine measurement, serum
Item
serum creatinine < 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Exclusion Heart failure New York Heart Association Classification
Item
no grade 3-4 cardiac failure
boolean
C2828389 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Left ventricular ejection fraction
Item
lvef ≥ 50%
boolean
C0428772 (UMLS CUI [1])
Exclusion Criteria | HIV Infection | Acquired Immunodeficiency Syndrome
Item
no known history of hiv or aids
boolean
C0680251 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0001175 (UMLS CUI [3])
Exclusion Criteria | Hepatitis | Hepatitis B
Item
no hepatitis or hepatitis b virus infection
boolean
C0680251 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
Exclusion Cancer Other | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma
Item
no other concurrent active malignancy, except carcinoma in situ of the cervix and basal cell carcinoma of the skin
boolean
C2828389 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
Exclusion Criteria | Mental condition Preventing Protocol Compliance | Condition Familial Preventing Protocol Compliance | Sociological Factors Preventing Protocol Compliance | Geographic Factors Preventing Protocol Compliance
Item
no psychological, familial, sociological, or geographical conditions that would prohibit treatment and/or medical follow-up required to comply with study protocol
boolean
C0680251 (UMLS CUI [1])
C3840291 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0241888 (UMLS CUI [3,2])
C1292733 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C3850138 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0017444 (UMLS CUI [5,1])
C1292733 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Exclusion Criteria | Chemotherapy Lymphoma | Immunotherapy Lymphoma | Therapeutic radiology procedure Lymphoma
Item
no prior chemotherapy, immunotherapy, or radiotherapy for this lymphoma
boolean
C0680251 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0024299 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0024299 (UMLS CUI [4,2])
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