ID

21228

Description

Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00363779

Link

https://clinicaltrials.gov/show/NCT00363779

Keywords

Versions (2)
  1. 4/13/17 4/13/17 -
  2. 4/13/17 4/13/17 -
Uploaded on

April 13, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Large Granular Lymphocytic Leukemia NCT00363779

English

Eligibility Large Granular Lymphocytic Leukemia NCT00363779

1 forms  
Criteria
Description

Criteria

1. all patients must have a histologic or cytologic diagnosis of t-cell lgl leukemia as determined by the laboratory of pathology or hematology at the clinical center, national institutes of health
Description

T-Cell Large Granular Lymphocyte Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1955861
2. all patients must have hemocytopenias such as granulocyte count less than 1,200/ul, platelet count less than 100,000/ul or hemoglobin less than 10 g/dl, or require hematopoietic support (transfusion or colony stimulating factors) to maintain counts at these or higher levels.
Description

Hemocytes Count Decreased | Granulocyte count | Platelet Count measurement | Hemoglobin measurement | Support Hematopoietic Patient need for | Blood Transfusion | Colony-Stimulating Factors

Data type

boolean

Alias
UMLS CUI [1,1]
C0019000
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0205216
UMLS CUI [2]
C0857490
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
UMLS CUI [5,1]
C1521721
UMLS CUI [5,2]
C0229601
UMLS CUI [5,3]
C0686904
UMLS CUI [6]
C0005841
UMLS CUI [7]
C0009392
3. patients must have measurable or evaluable disease
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
4. patients must have a creatinine of less than 2.0 mg/dl.
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
5. omission of cytotoxic chemotherapy for 3 weeks prior to entry into the trial is required. however, patients receiving stable corticosteroids will be eligible.
Description

Cytotoxic Chemotherapy Omission | Adrenal Cortex Hormones Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C3845736
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0205360
6. age greater than 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
7. karnofsky performance greater than 70%
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
8. patients must have a life expectancy of greater than 3 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
9. patients must be able to understand and sign an informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
10. all female patients must use adequate contraception during participation in this trial and for three months after completing therapy.
Description

Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
2. pregnant and nursing patients are not eligible for the study as csa crosses the placenta. based on clinical use, premature births and low birth weight were consistently observed. breast-feeding is contraindicated because csa enters the blood milk and may possibly be administered to the child.
Description

Pregnancy | Breast Feeding | Cyclosporine | Premature Birth | Low Birth Weight

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0010592
UMLS CUI [4]
C0151526
UMLS CUI [5]
C0024032
3. underlying immunodeficiency state including human immunodeficiency virus (hiv) seropositivity.
Description

Immunodeficiency | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C0019699
4. positive for antibodies to hepatitis c or positive for hepatitis b surface antigen,
Description

Hepatitis C antibody positive | Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0281863
UMLS CUI [2]
C0149709
5. patients with serious intercurrent illnesses, concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious or metabolic disease of such severity that it would preclude the patients' ability to tolerate cyclosporine.
Description

Comorbidity Serious Excluding Cyclosporine | Liver disease | Kidney Disease | Heart Disease | nervous system disorder | Lung disease | Communicable Disease | Metabolic Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2828389
UMLS CUI [1,4]
C0010592
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0027765
UMLS CUI [6]
C0024115
UMLS CUI [7]
C0009450
UMLS CUI [8]
C0025517
6. patients who received cyclosporine for lgl leukemia previously and failed to respond.
Description

Cyclosporine | Large Granular Lymphocytic Leukemia Absent response to treatment

Data type

boolean

Alias
UMLS CUI [1]
C0010592
UMLS CUI [2,1]
C1522378
UMLS CUI [2,2]
C0438286
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Similar models

Eligibility Large Granular Lymphocytic Leukemia NCT00363779

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
T-Cell Large Granular Lymphocyte Leukemia
Item
1. all patients must have a histologic or cytologic diagnosis of t-cell lgl leukemia as determined by the laboratory of pathology or hematology at the clinical center, national institutes of health
boolean
C1955861 (UMLS CUI [1])
Hemocytes Count Decreased | Granulocyte count | Platelet Count measurement | Hemoglobin measurement | Support Hematopoietic Patient need for | Blood Transfusion | Colony-Stimulating Factors
Item
2. all patients must have hemocytopenias such as granulocyte count less than 1,200/ul, platelet count less than 100,000/ul or hemoglobin less than 10 g/dl, or require hematopoietic support (transfusion or colony stimulating factors) to maintain counts at these or higher levels.
boolean
C0019000 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0205216 (UMLS CUI [1,3])
C0857490 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C1521721 (UMLS CUI [5,1])
C0229601 (UMLS CUI [5,2])
C0686904 (UMLS CUI [5,3])
C0005841 (UMLS CUI [6])
C0009392 (UMLS CUI [7])
Measurable Disease | Evaluable Disease
Item
3. patients must have measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Creatinine measurement, serum
Item
4. patients must have a creatinine of less than 2.0 mg/dl.
boolean
C0201976 (UMLS CUI [1])
Cytotoxic Chemotherapy Omission | Adrenal Cortex Hormones Stable
Item
5. omission of cytotoxic chemotherapy for 3 weeks prior to entry into the trial is required. however, patients receiving stable corticosteroids will be eligible.
boolean
C0677881 (UMLS CUI [1,1])
C3845736 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Age
Item
6. age greater than 18 years
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
7. karnofsky performance greater than 70%
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
8. patients must have a life expectancy of greater than 3 months.
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
9. patients must be able to understand and sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Gender Contraceptive methods
Item
10. all female patients must use adequate contraception during participation in this trial and for three months after completing therapy.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Uncontrolled hypertension
Item
1. patients with uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Pregnancy | Breast Feeding | Cyclosporine | Premature Birth | Low Birth Weight
Item
2. pregnant and nursing patients are not eligible for the study as csa crosses the placenta. based on clinical use, premature births and low birth weight were consistently observed. breast-feeding is contraindicated because csa enters the blood milk and may possibly be administered to the child.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0010592 (UMLS CUI [3])
C0151526 (UMLS CUI [4])
C0024032 (UMLS CUI [5])
Immunodeficiency | HIV Seropositivity
Item
3. underlying immunodeficiency state including human immunodeficiency virus (hiv) seropositivity.
boolean
C0021051 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Hepatitis C antibody positive | Hepatitis B surface antigen positive
Item
4. positive for antibodies to hepatitis c or positive for hepatitis b surface antigen,
boolean
C0281863 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Comorbidity Serious Excluding Cyclosporine | Liver disease | Kidney Disease | Heart Disease | nervous system disorder | Lung disease | Communicable Disease | Metabolic Disease
Item
5. patients with serious intercurrent illnesses, concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious or metabolic disease of such severity that it would preclude the patients' ability to tolerate cyclosporine.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0010592 (UMLS CUI [1,4])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0024115 (UMLS CUI [6])
C0009450 (UMLS CUI [7])
C0025517 (UMLS CUI [8])
Cyclosporine | Large Granular Lymphocytic Leukemia Absent response to treatment
Item
6. patients who received cyclosporine for lgl leukemia previously and failed to respond.
boolean
C0010592 (UMLS CUI [1])
C1522378 (UMLS CUI [2,1])
C0438286 (UMLS CUI [2,2])
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