ID

20091

Beschreibung

Lower But More Frequent Dose Rituximab to Treat Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00366418

Link

https://clinicaltrials.gov/show/NCT00366418

Stichworte

Versionen (1)
  1. 06.02.17 06.02.17 -
Hochgeladen am

6. Februar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukaemia Refractory NCT00366418

Englisch

Eligibility Chronic Lymphocytic Leukaemia Refractory NCT00366418

1 Formulare  
Criteria
Beschreibung

Criteria

patients diagnosed with chronic lymphocytic leukemia
Beschreibung

Chronic Lymphocytic Leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0023434
prior therapy with fludarabine or a fludarabine containing regimen
Beschreibung

fludarabine | Regimen fludarabine containing

Datentyp

boolean

Alias
UMLS CUI [1]
C0059985
UMLS CUI [2,1]
C0040808
UMLS CUI [2,2]
C0059985
UMLS CUI [2,3]
C0332256
cd20 expression on cll cells
Beschreibung

CD20 Expression Chronic Lymphocytic Leukemia Cells

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0054946
UMLS CUI [1,2]
C0017262
UMLS CUI [1,3]
C0023434
UMLS CUI [1,4]
C0007634
neutrophil count anc greater than 500/mm(3)
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet count greater than 30k/mm(3)
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
age 21-99
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
bulky lymphadenopathy, defined as greater than 1 lymph node with greater than 5cm in largest diameter
Beschreibung

Lymphadenopathy Bulky | Lymph nodes Quantity Diameter size

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C1511341
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1301886
UMLS CUI [2,4]
C0456389
evidence for transformation into high grade lymphoma (richter's transformation)
Beschreibung

Transformation High Grade Lymphoma Evidence of | Richter's syndrome

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3714584
UMLS CUI [1,2]
C0079740
UMLS CUI [1,3]
C0332120
UMLS CUI [2]
C0349631
ecog performance 3 or higher
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
other concurrent anticancer therapies
Beschreibung

cancer treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
less than 3 months from last systemic therapy for cll
Beschreibung

systemic therapy Chronic Lymphocytic Leukemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0023434
less than 6 months from last monoclonal antibody therapy
Beschreibung

Monoclonal Antibody Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0279694
more than 10 doses rituximab, within 12 months preceeding protocol enrollment, either as single agent or in a combination chemotherapy regimen
Beschreibung

rituximab Dose Quantity | rituximab Chemotherapy, multiple agents (combination regimen)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0393022
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0393022
UMLS CUI [2,2]
C3846439
chronic or current clinically significant infection, including hiv positivity or hepatitis c
Beschreibung

Communicable Disease Clinical Significance | HIV Seropositivity | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0019699
UMLS CUI [3]
C0019196
moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy
Beschreibung

Moribund | Liver disease Severe | Kidney Disease Severe | Heart Disease Severe | nervous system disorder Severe | Lung disease Severe | Communicable Disease Severe | Metabolic Disease Severe | Disease Severe Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1]
C0424547
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0027765
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0024115
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0009450
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C0025517
UMLS CUI [8,2]
C0205082
UMLS CUI [9,1]
C0012634
UMLS CUI [9,2]
C0205082
UMLS CUI [9,3]
C0525058
UMLS CUI [9,4]
C1299582
history of mucocutaneous reactions (paraneoplastic pemphigus, stevens-johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis)
Beschreibung

Mucous Membrane Reaction | Paraneoplastic pemphigus | Stevens-Johnson Syndrome | Lichenoid Eruptions | Skin Diseases, Vesiculobullous | Toxic Epidermal Necrolysis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026724
UMLS CUI [1,2]
C0443286
UMLS CUI [2]
C1112570
UMLS CUI [3]
C0038325
UMLS CUI [4]
C0162848
UMLS CUI [5]
C0037275
UMLS CUI [6]
C0014518
known anaphylaxis or ige mediated hypersensitivity to murine proteins or to any component of this product
Beschreibung

Anaphylaxis Murine protein | IgE-mediated hypersensitivity Murine protein | Anaphylaxis Murine protein Component | IgE-mediated hypersensitivity Murine protein Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C1699668
UMLS CUI [2,1]
C0020523
UMLS CUI [2,2]
C1699668
UMLS CUI [3,1]
C0002792
UMLS CUI [3,2]
C1699668
UMLS CUI [3,3]
C1705248
UMLS CUI [4,1]
C0020523
UMLS CUI [4,2]
C1699668
UMLS CUI [4,3]
C1705248
inability to self inject the study medication or to have it administered by a third person
Beschreibung

Investigational New Drug Injection Self Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C0036588
UMLS CUI [1,4]
C1299582
inability to understand the investigational nature of the study ability to provide informed consent
Beschreibung

Study Protocol Comprehension Unable | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0021430
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Ähnliche Modelle

Eligibility Chronic Lymphocytic Leukaemia Refractory NCT00366418

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Chronic Lymphocytic Leukemia
Item
patients diagnosed with chronic lymphocytic leukemia
boolean
C0023434 (UMLS CUI [1])
fludarabine | Regimen fludarabine containing
Item
prior therapy with fludarabine or a fludarabine containing regimen
boolean
C0059985 (UMLS CUI [1])
C0040808 (UMLS CUI [2,1])
C0059985 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
CD20 Expression Chronic Lymphocytic Leukemia Cells
Item
cd20 expression on cll cells
boolean
C0054946 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C0007634 (UMLS CUI [1,4])
Absolute neutrophil count
Item
neutrophil count anc greater than 500/mm(3)
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count greater than 30k/mm(3)
boolean
C0032181 (UMLS CUI [1])
Age
Item
age 21-99
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lymphadenopathy Bulky | Lymph nodes Quantity Diameter size
Item
bulky lymphadenopathy, defined as greater than 1 lymph node with greater than 5cm in largest diameter
boolean
C0497156 (UMLS CUI [1,1])
C1511341 (UMLS CUI [1,2])
C0024204 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0456389 (UMLS CUI [2,4])
Transformation High Grade Lymphoma Evidence of | Richter's syndrome
Item
evidence for transformation into high grade lymphoma (richter's transformation)
boolean
C3714584 (UMLS CUI [1,1])
C0079740 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0349631 (UMLS CUI [2])
ECOG performance status
Item
ecog performance 3 or higher
boolean
C1520224 (UMLS CUI [1])
cancer treatment
Item
other concurrent anticancer therapies
boolean
C0920425 (UMLS CUI [1])
systemic therapy Chronic Lymphocytic Leukemia
Item
less than 3 months from last systemic therapy for cll
boolean
C1515119 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
Monoclonal Antibody Therapy
Item
less than 6 months from last monoclonal antibody therapy
boolean
C0279694 (UMLS CUI [1])
rituximab Dose Quantity | rituximab Chemotherapy, multiple agents (combination regimen)
Item
more than 10 doses rituximab, within 12 months preceeding protocol enrollment, either as single agent or in a combination chemotherapy regimen
boolean
C0393022 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0393022 (UMLS CUI [2,1])
C3846439 (UMLS CUI [2,2])
Communicable Disease Clinical Significance | HIV Seropositivity | Hepatitis C
Item
chronic or current clinically significant infection, including hiv positivity or hepatitis c
boolean
C0009450 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0019699 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Moribund | Liver disease Severe | Kidney Disease Severe | Heart Disease Severe | nervous system disorder Severe | Lung disease Severe | Communicable Disease Severe | Metabolic Disease Severe | Disease Severe Protocol Compliance Unable
Item
moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy
boolean
C0424547 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0027765 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0024115 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0009450 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0025517 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0012634 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0525058 (UMLS CUI [9,3])
C1299582 (UMLS CUI [9,4])
Mucous Membrane Reaction | Paraneoplastic pemphigus | Stevens-Johnson Syndrome | Lichenoid Eruptions | Skin Diseases, Vesiculobullous | Toxic Epidermal Necrolysis
Item
history of mucocutaneous reactions (paraneoplastic pemphigus, stevens-johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis)
boolean
C0026724 (UMLS CUI [1,1])
C0443286 (UMLS CUI [1,2])
C1112570 (UMLS CUI [2])
C0038325 (UMLS CUI [3])
C0162848 (UMLS CUI [4])
C0037275 (UMLS CUI [5])
C0014518 (UMLS CUI [6])
Anaphylaxis Murine protein | IgE-mediated hypersensitivity Murine protein | Anaphylaxis Murine protein Component | IgE-mediated hypersensitivity Murine protein Component
Item
known anaphylaxis or ige mediated hypersensitivity to murine proteins or to any component of this product
boolean
C0002792 (UMLS CUI [1,1])
C1699668 (UMLS CUI [1,2])
C0020523 (UMLS CUI [2,1])
C1699668 (UMLS CUI [2,2])
C0002792 (UMLS CUI [3,1])
C1699668 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C0020523 (UMLS CUI [4,1])
C1699668 (UMLS CUI [4,2])
C1705248 (UMLS CUI [4,3])
Investigational New Drug Injection Self Unable
Item
inability to self inject the study medication or to have it administered by a third person
boolean
C0013230 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0036588 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Study Protocol Comprehension Unable | Informed Consent
Item
inability to understand the investigational nature of the study ability to provide informed consent
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2])
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