ID

21490

Description

This Study is Being Performed to Evaluate the Effect of Genasense on the Efficacy and the Safety of Rituximab/Fludarabine Combination Treatment in Previously Untreated Subjects With Chronic Lymphocyctic Leukemia(CLL); ODM derived from: https://clinicaltrials.gov/show/NCT00517218

Link

https://clinicaltrials.gov/show/NCT00517218

Keywords

Versions (1)
  1. 4/24/17 4/24/17 -
Uploaded on

April 24, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphocytic Leukemia NCT00517218

English

Eligibility Lymphocytic Leukemia NCT00517218

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
previously untreated subjects with intermediate-or high-risk cll(modified rai stages i-iv)
Description

Study Subject untreated | Chronic Lymphocytic Leukemia Intermediate Rai Staging System | Chronic Lymphocytic Leukemia High risk Rai Staging System

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0023434
UMLS CUI [2,2]
C0205103
UMLS CUI [2,3]
C1514715
UMLS CUI [3,1]
C0023434
UMLS CUI [3,2]
C0332167
UMLS CUI [3,3]
C1514715
measurable disease as primarily established by the national cancer institute-sponsored working group(nci-wg) guidelines for the diagnosis of cll
Description

Measurable Disease | Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0023434
requiring therapy for active disease, as primarily defined by the nci-wg guidelines
Description

Disease Requirement Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
eastern cooperative oncology group performance status < 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function determined , 14 days prior to the first dose of study medication
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
absolute lymphocyte count > 100,000/ul
Description

Absolute lymphocyte count

Data type

boolean

Alias
UMLS CUI [1]
C3544087
prior chemotherapy or other therapy for cll, including allogeneic transplant
Description

Chemotherapy Chronic Lymphocytic Leukemia | Therapeutic procedure Chronic Lymphocytic Leukemia | Transplantation, Homologous

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0023434
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0023434
UMLS CUI [3]
C0040739
less than 3 weeks from any prior major surgery at the time of informed consent
Description

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
failure to recover from any serious adverse effect of surgery
Description

Operative Surgical Procedures Adverse effects Serious | Recovering failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0879626
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C0521108
UMLS CUI [2,2]
C0231175
history of autoimmune hemolytic anemia or autoimmune thrombocytopenia
Description

Autoimmune hemolytic anemia | Autoimmune thrombocytopenia

Data type

boolean

Alias
UMLS CUI [1]
C0002880
UMLS CUI [2]
C0242584
active serious infection requiring systemic anti-infective therapy
Description

Communicable Disease Serious | Anti-infective therapy Systemic Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1141958
UMLS CUI [2,2]
C0205373
UMLS CUI [2,3]
C0686904
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Similar models

Eligibility Lymphocytic Leukemia NCT00517218

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject untreated | Chronic Lymphocytic Leukemia Intermediate Rai Staging System | Chronic Lymphocytic Leukemia High risk Rai Staging System
Item
previously untreated subjects with intermediate-or high-risk cll(modified rai stages i-iv)
boolean
C0681850 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0023434 (UMLS CUI [2,1])
C0205103 (UMLS CUI [2,2])
C1514715 (UMLS CUI [2,3])
C0023434 (UMLS CUI [3,1])
C0332167 (UMLS CUI [3,2])
C1514715 (UMLS CUI [3,3])
Measurable Disease | Chronic Lymphocytic Leukemia
Item
measurable disease as primarily established by the national cancer institute-sponsored working group(nci-wg) guidelines for the diagnosis of cll
boolean
C1513041 (UMLS CUI [1])
C0023434 (UMLS CUI [2])
Disease Requirement Therapeutic procedure
Item
requiring therapy for active disease, as primarily defined by the nci-wg guidelines
boolean
C0012634 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group performance status < 2
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function determined , 14 days prior to the first dose of study medication
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Absolute lymphocyte count
Item
absolute lymphocyte count > 100,000/ul
boolean
C3544087 (UMLS CUI [1])
Chemotherapy Chronic Lymphocytic Leukemia | Therapeutic procedure Chronic Lymphocytic Leukemia | Transplantation, Homologous
Item
prior chemotherapy or other therapy for cll, including allogeneic transplant
boolean
C0392920 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])
C0040739 (UMLS CUI [3])
major surgery
Item
less than 3 weeks from any prior major surgery at the time of informed consent
boolean
C0679637 (UMLS CUI [1])
Operative Surgical Procedures Adverse effects Serious | Recovering failed
Item
failure to recover from any serious adverse effect of surgery
boolean
C0543467 (UMLS CUI [1,1])
C0879626 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0521108 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Autoimmune hemolytic anemia | Autoimmune thrombocytopenia
Item
history of autoimmune hemolytic anemia or autoimmune thrombocytopenia
boolean
C0002880 (UMLS CUI [1])
C0242584 (UMLS CUI [2])
Communicable Disease Serious | Anti-infective therapy Systemic Patient need for
Item
active serious infection requiring systemic anti-infective therapy
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1141958 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
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