ID

16817

Description

CFAR Study in Patients With Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00525603

Link

https://clinicaltrials.gov/show/NCT00525603

Keywords

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

August 8, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Leukemia NCT00525603

English

Eligibility Leukemia NCT00525603

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00525603
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must have a diagnosis of cll by immunophenotyping and flow cytometry analysis of blood or bone marrow and be previously untreated.
Description

Untreated chronic lymphocytic leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0332155
all patients must be younger than 70 years and have a serum beta-2 microglobulin of >/= 4.0mg/l.
Description

Age, serum beta-2 microglobulin

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0201910
all patients with rai stage iii-iv are eligible for treatment on this protocol. - or- all patients with rai stage 0-ii who meet one or more indication for treatment as defined by the nci-sponsored working group are eligible for treatment on this protocol.
Description

Rai stage

Data type

boolean

Alias
UMLS CUI [1]
C1514715
all patients must have a zubrod performance status of 0-3.
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
all patients must have adequate renal and hepatic function (serum creatinine </= 2mg/dl; total bilirubin </= 2.5mg/dl). patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the principle investigator and appropriate dose adjustment considered.
Description

renal and hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0201913
patients may not receive concurrent chemotherapy, radiotherapy, or immunotherapy. localized radiotherapy to an area not compromising bone marrow function does not apply, nor do hematopoietic growth factors such as erythropoietin, granulocyte colony-stimulating factor (g-csf), granulocyte-macrophage colony stimulating factor (gm-csf), etc.
Description

Concurrent Chemotherapy, Radiotherapy, or Immunotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C0009429
UMLS CUI [2,2]
C1522449
UMLS CUI [3,1]
C0009429
UMLS CUI [3,2]
C0021083
patients must not have untreated or uncontrolled life-threatening infection.
Description

Infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
patients must sign informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients older than 70 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Back to the top of the page

Similar models

Eligibility Leukemia NCT00525603

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00525603
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Untreated chronic lymphocytic leukemia
Item
all patients must have a diagnosis of cll by immunophenotyping and flow cytometry analysis of blood or bone marrow and be previously untreated.
boolean
C0023434 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Age, serum beta-2 microglobulin
Item
all patients must be younger than 70 years and have a serum beta-2 microglobulin of >/= 4.0mg/l.
boolean
C0001779 (UMLS CUI [1])
C0201910 (UMLS CUI [2])
Rai stage
Item
all patients with rai stage iii-iv are eligible for treatment on this protocol. - or- all patients with rai stage 0-ii who meet one or more indication for treatment as defined by the nci-sponsored working group are eligible for treatment on this protocol.
boolean
C1514715 (UMLS CUI [1])
Zubrod Performance Status
Item
all patients must have a zubrod performance status of 0-3.
boolean
C3714786 (UMLS CUI [1])
renal and hepatic function
Item
all patients must have adequate renal and hepatic function (serum creatinine </= 2mg/dl; total bilirubin </= 2.5mg/dl). patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the principle investigator and appropriate dose adjustment considered.
boolean
C0201976 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
Concurrent Chemotherapy, Radiotherapy, or Immunotherapy
Item
patients may not receive concurrent chemotherapy, radiotherapy, or immunotherapy. localized radiotherapy to an area not compromising bone marrow function does not apply, nor do hematopoietic growth factors such as erythropoietin, granulocyte colony-stimulating factor (g-csf), granulocyte-macrophage colony stimulating factor (gm-csf), etc.
boolean
C0009429 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0009429 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0009429 (UMLS CUI [3,1])
C0021083 (UMLS CUI [3,2])
Infection
Item
patients must not have untreated or uncontrolled life-threatening infection.
boolean
C0009450 (UMLS CUI [1])
Informed consent
Item
patients must sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
patients older than 70 years.
boolean
C0001779 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial