ID

25285

Description

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

Link

https://clinicaltrials.gov/show/NCT00472849

Keywords

  1. 8/30/17 8/30/17 -
Uploaded on

August 30, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Richter's Transformation NCT00472849

Eligibility Richter's Transformation NCT00472849

Inclusion Criteria
Description

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.
Description

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

Data type

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.
Description

Age

Data type

boolean

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

Zubrod Performance Status

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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.
Description

Childbearing Potential Contraceptive methods | Postmenopausal state | Gender Contraceptive methods

Data type

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.
Description

Informed Consent

Data type

boolean

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

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

Data type

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
Description

Exclusion Criteria

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

Life-threatening infections untreated | Life-threatening infections Uncontrolled

Data type

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.
Description

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

Data type

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.
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Chemotherapy | Therapeutic radiology procedure

Data type

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.
Description

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

Data type

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

Similar models

Eligibility Richter's Transformation NCT00472849

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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