ID

16685

Description

Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.; ODM derived from: https://clinicaltrials.gov/show/NCT00131313

Link

https://clinicaltrials.gov/show/NCT00131313

Keywords

Versions (1)
  1. 8/1/16 8/1/16 -
Uploaded on

August 1, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00131313

English

Eligibility Chronic Lymphocytic Leukemia NCT00131313

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage ii, iii or iv chronic lymphocytic leukemia
Description

Chronic Lymphocytic Leukemia | stage, chronic lymphocytic leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C0280248
disease requires chemotherapeutic treatment
Description

Disease Requirement Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0392920
ct or mri scan confirming measurable tumor size
Description

Tumor size Measurable | X-Ray Computed Tomography | Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1513040
UMLS CUI [2]
C0040405
UMLS CUI [3]
C0024485
documentation of cd markers
Description

CD Antigens Documentation

Data type

boolean

Alias
UMLS CUI [1,1]
C0003322
UMLS CUI [1,2]
C0175636
up to one prior treatment regimen
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
expected survival greater than 6 months
Description

Survival time Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C2919552
UMLS CUI [1,2]
C1517001
ecog performance status of 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate renal, bone marrow and liver functions
Description

Renal function | Bone Marrow function | Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0232741
negative pregnancy test (females of childbearing potential)
Description

Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
must agree to use acceptable birth control, if fertile
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
must complete informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
no heart disease and must have adequate cardiac function
Description

Heart Diseases | Cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0232164
must test negative for viral hepatitis b and c
Description

Hepatitis B test negative | Hepatitis C test negative

Data type

boolean

Alias
UMLS CUI [1]
C1611173
UMLS CUI [2]
C1619717
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than one prior treatment for chronic lymphocytic leukemia
Description

Prior Therapy Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0023434
known sensitivity to nipent, rituxan or cytoxan or any component of these drugs
Description

Hypersensitivity Nipent | Hypersensitivity Rituxan | Hypersensitivity Cytoxan | Hypersensitivity Nipent Compound | Hypersensitivity Rituxan Compound | Hypersensitivity Cytoxan Compound

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0591865
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0732355
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0699319
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0591865
UMLS CUI [4,3]
C1706082
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0732355
UMLS CUI [5,3]
C1706082
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0699319
UMLS CUI [6,3]
C1706082
known hiv or aids illness
Description

HIV | Acquired Immunodeficiency Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0001175
thyroid disease requiring medication
Description

Thyroid Disease Requirement Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
history of any malignancy that could affect the diagnosis or assessment of the study treatment
Description

Malignant Neoplasms Affecting Diagnosis | Malignant Neoplasms Affecting research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0011900
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0683954
pregnancy or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
evidence of hepatitis b or c infection
Description

Hepatitis B Evidence | Hepatitis C Evidence

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0332120
inability to comply with the requirements of the study
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00131313

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia | stage, chronic lymphocytic leukemia
Item
stage ii, iii or iv chronic lymphocytic leukemia
boolean
C0023434 (UMLS CUI [1])
C0280248 (UMLS CUI [2])
Disease Requirement Chemotherapy
Item
disease requires chemotherapeutic treatment
boolean
C0012634 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Tumor size Measurable | X-Ray Computed Tomography | Magnetic Resonance Imaging
Item
ct or mri scan confirming measurable tumor size
boolean
C0475440 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0040405 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
CD Antigens Documentation
Item
documentation of cd markers
boolean
C0003322 (UMLS CUI [1,1])
C0175636 (UMLS CUI [1,2])
Prior Therapy
Item
up to one prior treatment regimen
boolean
C1514463 (UMLS CUI [1])
Survival time Expected
Item
expected survival greater than 6 months
boolean
C2919552 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Renal function | Bone Marrow function | Liver function
Item
adequate renal, bone marrow and liver functions
boolean
C0232804 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3])
Childbearing Potential Pregnancy test negative
Item
negative pregnancy test (females of childbearing potential)
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Fertility Contraceptive methods
Item
must agree to use acceptable birth control, if fertile
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed consent
Item
must complete informed consent
boolean
C0021430 (UMLS CUI [1])
Heart Diseases | Cardiac function
Item
no heart disease and must have adequate cardiac function
boolean
C0018799 (UMLS CUI [1])
C0232164 (UMLS CUI [2])
Hepatitis B test negative | Hepatitis C test negative
Item
must test negative for viral hepatitis b and c
boolean
C1611173 (UMLS CUI [1])
C1619717 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Chronic Lymphocytic Leukemia
Item
more than one prior treatment for chronic lymphocytic leukemia
boolean
C1514463 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
Hypersensitivity Nipent | Hypersensitivity Rituxan | Hypersensitivity Cytoxan | Hypersensitivity Nipent Compound | Hypersensitivity Rituxan Compound | Hypersensitivity Cytoxan Compound
Item
known sensitivity to nipent, rituxan or cytoxan or any component of these drugs
boolean
C0020517 (UMLS CUI [1,1])
C0591865 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0732355 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0699319 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0591865 (UMLS CUI [4,2])
C1706082 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0732355 (UMLS CUI [5,2])
C1706082 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0699319 (UMLS CUI [6,2])
C1706082 (UMLS CUI [6,3])
HIV | Acquired Immunodeficiency Syndrome
Item
known hiv or aids illness
boolean
C0019682 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
Thyroid Disease Requirement Pharmaceutical Preparations
Item
thyroid disease requiring medication
boolean
C0040128 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Malignant Neoplasms Affecting Diagnosis | Malignant Neoplasms Affecting research results
Item
history of any malignancy that could affect the diagnosis or assessment of the study treatment
boolean
C0006826 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis B Evidence | Hepatitis C Evidence
Item
evidence of hepatitis b or c infection
boolean
C0019163 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Protocol Compliance
Item
inability to comply with the requirements of the study
boolean
C0525058 (UMLS CUI [1])
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