ID

18486

Beschrijving

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

Trefwoorden

  1. 07-11-16 07-11-16 -
Geüploaded op

7 november 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Chronic Lymphocytic Leukemia NCT00558961

Eligibility Chronic Lymphocytic Leukemia NCT00558961

Inclusion Criteria
Beschrijving

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.
Beschrijving

B-cell chronic lymphocytic leukemia variant | Rai Staging System

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Leukocytes

Datatype

boolean

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

ECOG performance status

Datatype

boolean

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

Renal function | Liver function

Datatype

boolean

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

undefined item

Datatype

boolean

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

neutrophil | Transfusion (procedure)

Datatype

boolean

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

Exclusion Criteria

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

undefined item

Datatype

boolean

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

Cardiovascular Diseases | New York Heart Association Classification

Datatype

boolean

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

Comorbidity; Affecting; Ribavirin

Datatype

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
Beschrijving

Long-term current use of steroid

Datatype

boolean

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

HIV Seropositivity | Hepatitis B | Hepatitis C

Datatype

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).
Beschrijving

Comorbidity | Malignant neoplasm of skin; Carcinoma in Situ

Datatype

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.
Beschrijving

Chronic Lymphocytic Leukemia; Therapeutic procedure

Datatype

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)
Datatype
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])

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