ID

28065

Descripción

The Humanized Monoclonal Antibody Milatuzumab for Refractory Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT00868478

Link

https://clinicaltrials.gov/show/NCT00868478

Palabras clave

Versiones (1)
  1. 14/12/17 14/12/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

14 de diciembre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00868478

Inglés

Eligibility Chronic Lymphocytic Leukemia NCT00868478

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
b-cll confirmed according to nci criteria
Descripción

Chronic Lymphocytic Leukemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023434
cll relapsed or refractory to prior antineoplastic therapy
Descripción

Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory Antineoplastic Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0854802
UMLS CUI [2,1]
C0278791
UMLS CUI [2,2]
C2346834
signs of progressive disease; at least one:
Descripción

Signs Quantity Progressive Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0220912
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1335499
b symptoms
Descripción

B-Symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1706867
lymphocyte doubling time of < 6 months
Descripción

Lymphocyte Doubling Time

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024264
UMLS CUI [1,2]
C2986483
symptomatic lymphadenopathy or splenomegaly
Descripción

Lymphadenopathy Symptomatic | Splenomegaly Symptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0038002
UMLS CUI [2,2]
C0231220
cytopenias due to bone marrow failure)
Descripción

Cytopenia Due to Bone marrow failure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0010828
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1855710
age > 18 years, and less then 80
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
serum alat, asat, bilirubin, creatinine < 2x upper limit of normal
Descripción

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201976
life expectancy > 6 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
patient's written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
active bacterial or viral infection
Descripción

Bacterial Infections | Virus Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2]
C0042769
hypersensitivity to humanized monoclonal antibodies
Descripción

Hypersensitivity Humanized Monoclonal Antibodies

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2985546
concurrent antineoplastic treatment for cll or other malignant disease
Descripción

Antineoplastic Therapy CLL | Antineoplastic Therapy Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2346834
UMLS CUI [1,2]
C0023434
UMLS CUI [2,1]
C2346834
UMLS CUI [2,2]
C0006826
absolute neutrophil count < 1.5 k/
Descripción

Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00868478

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia
Item
b-cll confirmed according to nci criteria
boolean
C0023434 (UMLS CUI [1])
Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory Antineoplastic Therapy
Item
cll relapsed or refractory to prior antineoplastic therapy
boolean
C0854802 (UMLS CUI [1])
C0278791 (UMLS CUI [2,1])
C2346834 (UMLS CUI [2,2])
Signs Quantity Progressive Disease
Item
signs of progressive disease; at least one:
boolean
C0220912 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1335499 (UMLS CUI [1,3])
B-Symptoms
Item
b symptoms
boolean
C1706867 (UMLS CUI [1])
Lymphocyte Doubling Time
Item
lymphocyte doubling time of < 6 months
boolean
C0024264 (UMLS CUI [1,1])
C2986483 (UMLS CUI [1,2])
Lymphadenopathy Symptomatic | Splenomegaly Symptomatic
Item
symptomatic lymphadenopathy or splenomegaly
boolean
C0497156 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0038002 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Cytopenia Due to Bone marrow failure
Item
cytopenias due to bone marrow failure)
boolean
C0010828 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1855710 (UMLS CUI [1,3])
Age
Item
age > 18 years, and less then 80
boolean
C0001779 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum
Item
serum alat, asat, bilirubin, creatinine < 2x upper limit of normal
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
Life Expectancy
Item
life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
patient's written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bacterial Infections | Virus Diseases
Item
active bacterial or viral infection
boolean
C0004623 (UMLS CUI [1])
C0042769 (UMLS CUI [2])
Hypersensitivity Humanized Monoclonal Antibodies
Item
hypersensitivity to humanized monoclonal antibodies
boolean
C0020517 (UMLS CUI [1,1])
C2985546 (UMLS CUI [1,2])
Antineoplastic Therapy CLL | Antineoplastic Therapy Malignant Neoplasms
Item
concurrent antineoplastic treatment for cll or other malignant disease
boolean
C2346834 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C2346834 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Absolute neutrophil count
Item
absolute neutrophil count < 1.5 k/
boolean
C0948762 (UMLS CUI [1])
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