ID

25285

Descrizione

Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter's Transformation and Leukemias; ODM derived from: https://clinicaltrials.gov/show/NCT00472849

collegamento

https://clinicaltrials.gov/show/NCT00472849

Keywords

versioni (1)
  1. 30/08/17 30/08/17 -
Caricato su

30 agosto 2017

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Richter's Transformation NCT00472849

Inglese

Eligibility Richter's Transformation NCT00472849

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients with histologically or cytologically confirmed richter's transformation, prolymphocytic leukemia, aggressive, or relapsed/refractory b-cell chronic lymphocytic leukemia are eligible for this protocol.
Descrizione

Richter's syndrome | Prolymphocytic Leukemia | Chronic Lymphocytic Leukemia Aggressive | Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0349631
UMLS CUI [2]
C0023486
UMLS CUI [3,1]
C0023434
UMLS CUI [3,2]
C0580822
UMLS CUI [4]
C0854802
UMLS CUI [5]
C0278791
patients must be 18 years of age or older.
Descrizione

Age

Tipo di dati

boolean

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

Zubrod Performance Status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3714786
patients must have adequate renal function (serum creatinine <= 2 mg/dl or creatinine clearance > 50 ml/min). patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the principal investigator (pi) and consideration of appropriate dose adjustments.
Descrizione

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

Tipo di dati

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 [5,1]
C0178784
UMLS CUI [5,2]
C0332448
UMLS CUI [5,3]
C0015127
UMLS CUI [5,4]
C0012634
patients must have adequate hepatic function (bilirubin <= 2 mg/dl; aspartate aminotransferase (ast or sgot) and alanine aminotransferase (alt or sgpt) < 2.5 * the upper limit of normal (uln) for the reference lab unless due to leukemia or congenital hemolytic disorder [for bilirubin]). patients with hepatic dysfunction due to organ infiltration by disease may be eligible after discussion with the pi and consideration of appropriate dose adjustments.
Descrizione

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement Due to Leukemia | Serum total bilirubin measurement Due to Hemolytic disorder Congenital | Liver Dysfunction Due to Organ Infiltration | Organ Infiltration caused by Disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5,1]
C1278039
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0023418
UMLS CUI [6,1]
C1278039
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C1263988
UMLS CUI [6,4]
C1744681
UMLS CUI [7,1]
C0086565
UMLS CUI [7,2]
C0678226
UMLS CUI [7,3]
C0178784
UMLS CUI [7,4]
C0332448
UMLS CUI [8,1]
C0178784
UMLS CUI [8,2]
C0332448
UMLS CUI [8,3]
C0015127
UMLS CUI [8,4]
C0012634
female patients of childbearing potential (including those < 1 year post-menopausal) and male patients must agree to use contraception.
Descrizione

Childbearing Potential Contraceptive methods | Postmenopausal state | Gender Contraceptive methods

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
patients must have platelet counts > 20,000, unless lower counts are due to disease involvement or autoimmune disorders.
Descrizione

Platelet Count measurement | Platelet count Due to Involvement with Disease | Platelet count Due to Autoimmune Diseases

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C1287267
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1314939
UMLS CUI [2,4]
C0012634
UMLS CUI [3,1]
C1287267
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0004364
Exclusion Criteria
Descrizione

Exclusion Criteria

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

Life-threatening infections untreated | Life-threatening infections Uncontrolled

Tipo di dati

boolean

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

Intolerance to oxaliplatin | Intolerance to fludarabine | Intolerance to Cytarabine | Intolerance to rituximab

Tipo di dati

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
pregnancy or lactation.
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

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

Chemotherapy | Therapeutic radiology procedure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
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.
Descrizione

Medical condition Interferes with Informed Consent | Medical condition Interferes with Protocol Compliance | Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Interpretation Research results | Mental disorders | Substance Use Disorders

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0459471
UMLS CUI [4,4]
C0683954
UMLS CUI [5]
C0004936
UMLS CUI [6]
C0038586
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Similar models

Eligibility Richter's Transformation NCT00472849

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Richter's syndrome | Prolymphocytic Leukemia | Chronic Lymphocytic Leukemia Aggressive | Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory
Item
all patients with histologically or cytologically confirmed richter's transformation, prolymphocytic leukemia, aggressive, or relapsed/refractory b-cell chronic lymphocytic leukemia are eligible for this protocol.
boolean
C0349631 (UMLS CUI [1])
C0023486 (UMLS CUI [2])
C0023434 (UMLS CUI [3,1])
C0580822 (UMLS CUI [3,2])
C0854802 (UMLS CUI [4])
C0278791 (UMLS CUI [5])
Age
Item
patients must be 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Zubrod Performance Status
Item
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 | Organ Infiltration caused by Disease
Item
patients must have adequate renal function (serum creatinine <= 2 mg/dl or creatinine clearance > 50 ml/min). patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the principal investigator (pi) and consideration of appropriate dose adjustments.
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])
C0178784 (UMLS CUI [5,1])
C0332448 (UMLS CUI [5,2])
C0015127 (UMLS CUI [5,3])
C0012634 (UMLS CUI [5,4])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement Due to Leukemia | Serum total bilirubin measurement Due to Hemolytic disorder Congenital | Liver Dysfunction Due to Organ Infiltration | Organ Infiltration caused by Disease
Item
patients must have adequate hepatic function (bilirubin <= 2 mg/dl; aspartate aminotransferase (ast or sgot) and alanine aminotransferase (alt or sgpt) < 2.5 * the upper limit of normal (uln) for the reference lab unless due to leukemia or congenital hemolytic disorder [for bilirubin]). patients with hepatic dysfunction due to organ infiltration by disease may be eligible after discussion with the pi and consideration of appropriate dose adjustments.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C1278039 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0023418 (UMLS CUI [5,3])
C1278039 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C1263988 (UMLS CUI [6,3])
C1744681 (UMLS CUI [6,4])
C0086565 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C0178784 (UMLS CUI [7,3])
C0332448 (UMLS CUI [7,4])
C0178784 (UMLS CUI [8,1])
C0332448 (UMLS CUI [8,2])
C0015127 (UMLS CUI [8,3])
C0012634 (UMLS CUI [8,4])
Childbearing Potential Contraceptive methods | Postmenopausal state | Gender Contraceptive methods
Item
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])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Informed Consent
Item
patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
boolean
C0021430 (UMLS CUI [1])
Platelet Count measurement | Platelet count Due to Involvement with Disease | Platelet count Due to Autoimmune Diseases
Item
patients must have platelet counts > 20,000, unless lower counts are due to disease involvement or autoimmune disorders.
boolean
C0032181 (UMLS CUI [1])
C1287267 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0012634 (UMLS CUI [2,4])
C1287267 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0004364 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Life-threatening infections untreated | Life-threatening infections Uncontrolled
Item
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
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
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure
Item
chemotherapy and/or radiation therapy within 4 weeks.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Medical condition Interferes with Informed Consent | Medical condition Interferes with Protocol Compliance | Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Interpretation Research results | Mental disorders | Substance Use Disorders
Item
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])
C0021430 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0459471 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
C0004936 (UMLS CUI [5])
C0038586 (UMLS CUI [6])
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