ID

18486

Description

Dose Escalation Study of Gleevec and Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00558961

Link

https://clinicaltrials.gov/show/NCT00558961

Keywords

  1. 11/7/16 11/7/16 -
Uploaded on

November 7, 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.

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 Chronic Lymphocytic Leukemia NCT00558961

Eligibility Chronic Lymphocytic Leukemia NCT00558961

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
b-cell chronic lymphocytic leukemia (a) rai stage 0-ii with indication for treatment by nci working group criteria: or (b) rai stage iii or iv.
Description

B-cell chronic lymphocytic leukemia variant | Rai Staging System

Data type

boolean

Alias
UMLS CUI [1]
C0475774
UMLS CUI [2]
C1514715
received a minimum of one prior chemotherapy regimen. prior treatment with corticosteroids, immunotherapies, monoclonal antibodies or radiation therapy is permitted.
Description

Chemotherapy Regimen | Steroid therapy | Immunotherapy | Monoclonal Antibodies | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0149783
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0003250
UMLS CUI [5]
C1522449
white blood cell count > 25 x 10^9/l
Description

Leukocytes

Data type

boolean

Alias
UMLS CUI [1]
C0023516
ecog 0, 1,or 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate renal and hepatic function
Description

Renal function | Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
platelets > 75 x 10^9/l, transfusion independent.
Description

undefined item

Data type

boolean

Alias
UMLS CUI [1]
C0005821
UMLS CUI [2]
C1879316
neutrophils > 1.0 x 10^9/l, transfusion independent
Description

neutrophil | Transfusion (procedure)

Data type

boolean

Alias
UMLS CUI [1]
C0027950
UMLS CUI [2]
C1879316
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
documented prolymphocytic leukemia (pll; prolymphocytes, 55% in blood)
Description

undefined item

Data type

boolean

Alias
UMLS CUI [1]
C0023486
active cardiovascular disease as defined by nyha class iii-iv categorization.
Description

Cardiovascular Diseases | New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C1275491
intercurrent illness or medical condition precluding safe administration of ribavirin.
Description

Comorbidity; Affecting; Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0035525
concurrent use of chronic steroids, except as replacement therapy for adrenal insufficiency
Description

Long-term current use of steroid

Data type

boolean

Alias
UMLS CUI [1]
C4039307
known infection with hiv, hepatitis b or c.
Description

HIV Seropositivity | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
concurrent malignancy (other than resected basal or squamous cell skin cancers or in-situ carcinoma).
Description

Comorbidity | Malignant neoplasm of skin; Carcinoma in Situ

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C0007114
UMLS CUI [2,2]
C0007099
received any previous therapy for cll within 28 days prior to study entry.
Description

Chronic Lymphocytic Leukemia; Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0087111

Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00558961

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
B-cell chronic lymphocytic leukemia variant | Rai Staging System
Item
b-cell chronic lymphocytic leukemia (a) rai stage 0-ii with indication for treatment by nci working group criteria: or (b) rai stage iii or iv.
boolean
C0475774 (UMLS CUI [1])
C1514715 (UMLS CUI [2])
Chemotherapy Regimen | Steroid therapy | Immunotherapy | Monoclonal Antibodies | Therapeutic radiology procedure
Item
received a minimum of one prior chemotherapy regimen. prior treatment with corticosteroids, immunotherapies, monoclonal antibodies or radiation therapy is permitted.
boolean
C0392920 (UMLS CUI [1])
C0149783 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0003250 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
Leukocytes
Item
white blood cell count > 25 x 10^9/l
boolean
C0023516 (UMLS CUI [1])
ECOG performance status
Item
ecog 0, 1,or 2.
boolean
C1520224 (UMLS CUI [1])
Renal function | Liver function
Item
adequate renal and hepatic function
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
undefined item
Item
platelets > 75 x 10^9/l, transfusion independent.
boolean
C0005821 (UMLS CUI [1])
C1879316 (UMLS CUI [2])
neutrophil | Transfusion (procedure)
Item
neutrophils > 1.0 x 10^9/l, transfusion independent
boolean
C0027950 (UMLS CUI [1])
C1879316 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
undefined item
Item
documented prolymphocytic leukemia (pll; prolymphocytes, 55% in blood)
boolean
C0023486 (UMLS CUI [1])
Cardiovascular Diseases | New York Heart Association Classification
Item
active cardiovascular disease as defined by nyha class iii-iv categorization.
boolean
C0007222 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Comorbidity; Affecting; Ribavirin
Item
intercurrent illness or medical condition precluding safe administration of ribavirin.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0035525 (UMLS CUI [1,3])
Long-term current use of steroid
Item
concurrent use of chronic steroids, except as replacement therapy for adrenal insufficiency
boolean
C4039307 (UMLS CUI [1])
HIV Seropositivity | Hepatitis B | Hepatitis C
Item
known infection with hiv, hepatitis b or c.
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Comorbidity | Malignant neoplasm of skin; Carcinoma in Situ
Item
concurrent malignancy (other than resected basal or squamous cell skin cancers or in-situ carcinoma).
boolean
C0009488 (UMLS CUI [1])
C0007114 (UMLS CUI [2,1])
C0007099 (UMLS CUI [2,2])
Chronic Lymphocytic Leukemia; Therapeutic procedure
Item
received any previous therapy for cll within 28 days prior to study entry.
boolean
C0023434 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])

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

Fields marked with * are required.

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