ID

17893

Descripción

Oxaliplatin, Fludarabine, Cytarabine and Rituximab in Richter's Syndrome, Refractory CLL and PLL; ODM derived from: https://clinicaltrials.gov/show/NCT00452374

Link

https://clinicaltrials.gov/show/NCT00452374

Palabras clave

Versiones (2)
  1. 6/10/16 6/10/16 -
  2. 7/10/16 7/10/16 -
Subido en

7 de octubre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Leukemia NCT00452374

Inglés

Eligibility Leukemia NCT00452374

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00452374
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed richter's transformation, fludarabine-refractory chronic lymphocytic leukemia or prolymphocytic leukemia.
Descripción

Richter's syndrome | Chronic Lymphocytic Leukemia refractory | Prolymphocytic Leukemia refractory | fludarabine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0349631
UMLS CUI [2,1]
C0023434
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C0023486
UMLS CUI [3,2]
C0205269
UMLS CUI [4]
C0059985
2. patients must be 18 years of age or older.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
3. patients must have a performance status of 0-2 (zubrod scale).
Descripción

Zubrod Performance Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3714786
4. patients must have adequate renal function (serum creatinine below or equal to 2mg/dl or creatinine clearance greater than 30ml/min), unless renal dysfunction is considered due to organ infiltration by disease.
Descripción

Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Renal dysfunction Due to Organ Infiltration caused by Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
UMLS CUI [4,1]
C3279454
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0178784
UMLS CUI [4,4]
C0332448
UMLS CUI [4,5]
C0015127
UMLS CUI [4,6]
C0012634
5. patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; serum glutamic oxaloacetic transaminase (sgot) or serum glutamic pyruvic transaminase (sgpt) less than or equal to 3 times the upper limit of normal (uln) for the reference lab unless considered due to leukemia or congenital hemolytic disorder (for bilirubin).
Descripción

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | leukemia | Hemolytic disorder Congenital

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0023418
UMLS CUI [6,1]
C1263988
UMLS CUI [6,2]
C1744681
6. female patients of childbearing potential (including those <1 year post-menopausal) and male patients must agree to use contraception.
Descripción

Childbearing Potential Contraceptive methods | Postmenopausal state Duration Contraceptive methods | Gender Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0232970
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C0700589
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
7. patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
8. patients must have platelet counts greater or equal to 20,000, unless due to disease involvement, or autoimmune disorders.
Descripción

Platelet Count measurement | Disease Involvement with | Autoimmune Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1314939
UMLS CUI [3]
C0004364
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. untreated or uncontrolled life-threatening infection.
Descripción

Life-threatening infection untreated | Life-threatening infection Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1859430
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1859430
UMLS CUI [2,2]
C0205318
2. oxaliplatin, fludarabine, cytarabine or rituximab intolerance.
Descripción

intolerance to oxaliplatin | intolerance to fludarabine | intolerance to Cytarabine | intolerance to rituximab

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0069717
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0059985
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0010711
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0393022
3. pregnancy or lactation.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. chemotherapy and/or radiation therapy within 4 weeks.
Descripción

Chemotherapy | Therapeutic radiology procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
5. medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
Descripción

medical condition Interferes with Protocol Compliance | medical condition Interferes with research results | Mental disorders Interfere with Protocol Compliance | Mental disorders Interfere with research results | Substance Use Disorders Interfere with Protocol Compliance | Substance Use Disorders Interfere with research results

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
UMLS CUI [5,1]
C0038586
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0038586
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0683954
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Similar models

Eligibility Leukemia NCT00452374

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00452374
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Richter's syndrome | Chronic Lymphocytic Leukemia refractory | Prolymphocytic Leukemia refractory | fludarabine
Item
1. histologically or cytologically confirmed richter's transformation, fludarabine-refractory chronic lymphocytic leukemia or prolymphocytic leukemia.
boolean
C0349631 (UMLS CUI [1])
C0023434 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0023486 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0059985 (UMLS CUI [4])
Age
Item
2. patients must be 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Zubrod Performance Status
Item
3. patients must have a performance status of 0-2 (zubrod scale).
boolean
C3714786 (UMLS CUI [1])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Renal dysfunction Due to Organ Infiltration caused by Disease
Item
4. patients must have adequate renal function (serum creatinine below or equal to 2mg/dl or creatinine clearance greater than 30ml/min), unless renal dysfunction is considered due to organ infiltration by disease.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C3279454 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0178784 (UMLS CUI [4,3])
C0332448 (UMLS CUI [4,4])
C0015127 (UMLS CUI [4,5])
C0012634 (UMLS CUI [4,6])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | leukemia | Hemolytic disorder Congenital
Item
5. patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; serum glutamic oxaloacetic transaminase (sgot) or serum glutamic pyruvic transaminase (sgpt) less than or equal to 3 times the upper limit of normal (uln) for the reference lab unless considered due to leukemia or congenital hemolytic disorder (for bilirubin).
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0023418 (UMLS CUI [5])
C1263988 (UMLS CUI [6,1])
C1744681 (UMLS CUI [6,2])
Childbearing Potential Contraceptive methods | Postmenopausal state Duration Contraceptive methods | Gender Contraceptive methods
Item
6. female patients of childbearing potential (including those <1 year post-menopausal) and male patients must agree to use contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Informed Consent
Item
7. patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
boolean
C0021430 (UMLS CUI [1])
Platelet Count measurement | Disease Involvement with | Autoimmune Diseases
Item
8. patients must have platelet counts greater or equal to 20,000, unless due to disease involvement, or autoimmune disorders.
boolean
C0032181 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0004364 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Life-threatening infection untreated | Life-threatening infection Uncontrolled
Item
1. untreated or uncontrolled life-threatening infection.
boolean
C1859430 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1859430 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
intolerance to oxaliplatin | intolerance to fludarabine | intolerance to Cytarabine | intolerance to rituximab
Item
2. oxaliplatin, fludarabine, cytarabine or rituximab intolerance.
boolean
C1744706 (UMLS CUI [1,1])
C0069717 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0059985 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0010711 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0393022 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
3. pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure
Item
4. chemotherapy and/or radiation therapy within 4 weeks.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
medical condition Interferes with Protocol Compliance | medical condition Interferes with research results | Mental disorders Interfere with Protocol Compliance | Mental disorders Interfere with research results | Substance Use Disorders Interfere with Protocol Compliance | Substance Use Disorders Interfere with research results
Item
5. medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
C0038586 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0038586 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0683954 (UMLS CUI [6,3])
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