ID

43868

Descripción

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

Palabras clave

Versiones (2)
  1. 7/2/17 7/2/17 -
  2. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Chronic Lymphocytic Leukemia NCT00286780

Inglés

Eligibility Chronic Lymphocytic Leukemia NCT00286780

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Chronic Lymphocytic Leukemia

Tipo de datos

boolean

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

Systemic Chemotherapy Standard | Immunotherapy

Tipo de datos

boolean

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

Progressive Disease | Recurrent disease Post Therapeutic procedure

Tipo de datos

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)
Descripción

Indication Therapeutic procedure

Tipo de datos

boolean

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

ECOG performance status

Tipo de datos

boolean

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

Liver function | Renal function | Bone Marrow function

Tipo de datos

boolean

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

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.
Descripción

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

Tipo de datos

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
Descripción

Heart Disease New York Heart Association Classification

Tipo de datos

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)
Descripción

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

Tipo de datos

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
Descripción

Secondary Malignant Neoplasm | Malignant Neoplasms

Tipo de datos

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).
Descripción

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

Tipo de datos

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
Descripción

Medical contraindication rituximab

Tipo de datos

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;
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023494
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0039194
Volver a la parte superior de la página

Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00286780

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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