ID

43868

Description

Phase 2 Safety and Efficacy Study of AT-101 in Combination With Rituximab in Patients With Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00286780

Link

https://clinicaltrials.gov/show/NCT00286780

Keywords

Versions (2)
  1. 2/7/17 2/7/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00286780

English

Eligibility Chronic Lymphocytic Leukemia NCT00286780

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of cll as defined by the nci-working group
Description

Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023434
previous treatment with standard systemic chemotherapy or immunotherapy.
Description

Systemic Chemotherapy Standard | Immunotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C1442989
UMLS CUI [2]
C0021083
disease progression or relapse after treatment.
Description

Progressive Disease | Recurrent disease Post Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0087111
indication for treatment as defined by the nci working group guidelines (cheson, 1996)
Description

Indication Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0087111
ecog performance status ≤ 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate liver and renal and bone marrow function
Description

Liver function | Renal function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment of cll with chemotherapy, monoclonal antibody or radiotherapy within 60 days prior to entering the study. acute toxicities from prior therapy must have resolved to grade ≤ 1.
Description

Chemotherapy Chronic Lymphocytic Leukemia | Monoclonal Antibody Therapy Chronic Lymphocytic Leukemia | Therapeutic radiology procedure Chronic Lymphocytic Leukemia | Toxic effect resolved CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0023434
UMLS CUI [2,1]
C0279694
UMLS CUI [2,2]
C0023434
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0023434
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C1514893
UMLS CUI [4,3]
C1516728
class 3 or 4 cardiac disease as defined by the new york heart association functional classification
Description

Heart Disease New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, copd)
Description

Lung disease Severe | Lung disease Debilitation | Dyspnea at rest | Shortness of breath Significant | Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0742985
UMLS CUI [3]
C0743330
UMLS CUI [4,1]
C0013404
UMLS CUI [4,2]
C0750502
UMLS CUI [5]
C0024117
active secondary malignancy or history of other malignancy within the last five years
Description

Secondary Malignant Neoplasm | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C3266877
UMLS CUI [2]
C0006826
active symptomatic fungal, bacterial and/or viral infection including active hiv or viral hepatitis (a, b or c).
Description

Mycoses Symptomatic | Bacterial Infection Symptomatic | Virus Disease Symptomatic | HIV Infection | Hepatitis A | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0026946
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0004623
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0042769
UMLS CUI [3,2]
C0231220
UMLS CUI [4]
C0019693
UMLS CUI [5]
C0019159
UMLS CUI [6]
C0019163
UMLS CUI [7]
C0019196
patients who are contraindicated for treatment with rituximab
Description

Medical contraindication rituximab

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0393022
diagnosis of prolymphocytic leukemia, hairy cell leukemia, leukemic phase of non-hodgkin's lymphoma, or other non-b-cll b-cell malignancy;
Description

Prolymphocytic Leukemia | Hairy Cell Leukemia | Leukemic Phase of Non-Hodgkin's Lymphoma | Chronic Lymphocytic Leukemia | Malignant Neoplasm B-Lymphocytes

Data type

boolean

Alias
UMLS CUI [1]
C0023486
UMLS CUI [2]
C0023443
UMLS CUI [3]
C0852709
UMLS CUI [4]
C0023434
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C0004561
t-cll or other t-cell malignancy
Description

Leukemia, T-Cell, Chronic | Malignant Neoplasm T-Lymphocyte

Data type

boolean

Alias
UMLS CUI [1]
C0023494
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0039194
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00286780

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia
Item
diagnosis of cll as defined by the nci-working group
boolean
C0023434 (UMLS CUI [1])
Systemic Chemotherapy Standard | Immunotherapy
Item
previous treatment with standard systemic chemotherapy or immunotherapy.
boolean
C1883256 (UMLS CUI [1,1])
C1442989 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2])
Progressive Disease | Recurrent disease Post Therapeutic procedure
Item
disease progression or relapse after treatment.
boolean
C1335499 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Indication Therapeutic procedure
Item
indication for treatment as defined by the nci working group guidelines (cheson, 1996)
boolean
C3146298 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Liver function | Renal function | Bone Marrow function
Item
adequate liver and renal and bone marrow function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Chronic Lymphocytic Leukemia | Monoclonal Antibody Therapy Chronic Lymphocytic Leukemia | Therapeutic radiology procedure Chronic Lymphocytic Leukemia | Toxic effect resolved CTCAE Grades
Item
treatment of cll with chemotherapy, monoclonal antibody or radiotherapy within 60 days prior to entering the study. acute toxicities from prior therapy must have resolved to grade ≤ 1.
boolean
C0392920 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0279694 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0023434 (UMLS CUI [3,2])
C0600688 (UMLS CUI [4,1])
C1514893 (UMLS CUI [4,2])
C1516728 (UMLS CUI [4,3])
Heart Disease New York Heart Association Classification
Item
class 3 or 4 cardiac disease as defined by the new york heart association functional classification
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Lung disease Severe | Lung disease Debilitation | Dyspnea at rest | Shortness of breath Significant | Chronic Obstructive Airway Disease
Item
severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, copd)
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C0742985 (UMLS CUI [2,2])
C0743330 (UMLS CUI [3])
C0013404 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
C0024117 (UMLS CUI [5])
Secondary Malignant Neoplasm | Malignant Neoplasms
Item
active secondary malignancy or history of other malignancy within the last five years
boolean
C3266877 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Mycoses Symptomatic | Bacterial Infection Symptomatic | Virus Disease Symptomatic | HIV Infection | Hepatitis A | Hepatitis B | Hepatitis C
Item
active symptomatic fungal, bacterial and/or viral infection including active hiv or viral hepatitis (a, b or c).
boolean
C0026946 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0004623 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0042769 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0019693 (UMLS CUI [4])
C0019159 (UMLS CUI [5])
C0019163 (UMLS CUI [6])
C0019196 (UMLS CUI [7])
Medical contraindication rituximab
Item
patients who are contraindicated for treatment with rituximab
boolean
C1301624 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
Prolymphocytic Leukemia | Hairy Cell Leukemia | Leukemic Phase of Non-Hodgkin's Lymphoma | Chronic Lymphocytic Leukemia | Malignant Neoplasm B-Lymphocytes
Item
diagnosis of prolymphocytic leukemia, hairy cell leukemia, leukemic phase of non-hodgkin's lymphoma, or other non-b-cll b-cell malignancy;
boolean
C0023486 (UMLS CUI [1])
C0023443 (UMLS CUI [2])
C0852709 (UMLS CUI [3])
C0023434 (UMLS CUI [4])
C0006826 (UMLS CUI [5,1])
C0004561 (UMLS CUI [5,2])
Leukemia, T-Cell, Chronic | Malignant Neoplasm T-Lymphocyte
Item
t-cll or other t-cell malignancy
boolean
C0023494 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0039194 (UMLS CUI [2,2])
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