ID

30181

Description

Oral Clofarabine in Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT00800566

Link

https://clinicaltrials.gov/show/NCT00800566

Keywords

Versions (1)
  1. 5/18/18 5/18/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 18, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00800566

English

Eligibility Leukemia NCT00800566

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00800566
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with chronic lymphocytic leukemia (cll), cll/pll (as defined by fab [french-american-british classification]), small lymphocytic lymphoma (sll) and prolymphocytic leukemia (pll) who have relapsed from or are refractory to at least one fludarabine-based regimen and no greater than 2 regimens.
Description

Chronic Lymphocytic Leukemia French-American-British Classification | Prolymphocytic Leukemia French-American-British Classification | Small lymphocytic lymphoma recurrent | Small lymphocytic lymphoma refractory | Prolymphocytic Leukemia Recurrent | Prolymphocytic Leukemia refractory | Therapeutic procedure Based Fludarabine | Therapeutic procedure Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C2984084
UMLS CUI [2,1]
C0023486
UMLS CUI [2,2]
C2984084
UMLS CUI [3]
C0855096
UMLS CUI [4]
C0855097
UMLS CUI [5,1]
C0023486
UMLS CUI [5,2]
C0277556
UMLS CUI [6,1]
C0023486
UMLS CUI [6,2]
C0205269
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C1705938
UMLS CUI [7,3]
C0059985
UMLS CUI [8,1]
C0087111
UMLS CUI [8,2]
C1265611
absolute neutrophil count (anc) >= 1 x 109/l and platelet count >= 50 x 109/l.
Description

Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
adequate organ function as indicated by the following laboratory values: serum creatinine </= 1 mg/dl; if serum creatinine > 1 mg/dl, then the estimated glomerular filtration rate (gfr) must be > 60 ml/min/1.73 m2 as calculated by the modification of diet in renal disease equation; serum bilirubin </= 1.5 mg/dl x uln; aspartate transaminase (ast)or alanine transaminase (alt) </= 2.5 x uln; alkaline phosphatase </= 2.5 x uln.
Description

Organ function | Creatinine measurement, serum | Estimated Glomerular Filtration Rate Modification of diet in renal disease formula | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C3811844
UMLS CUI [3,2]
C3839656
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201850
ecog performance status <= 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
age >/= 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with nyha >/= grade 3 heart disease as assessed by history and/or physical examination.
Description

Heart Disease New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
pregnant or breastfeeding women or patients who are unwilling or unable to practice adequate contraception. positive pregnancy test for women of child bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization).
Description

Pregnancy | Breast Feeding | Contraceptive methods Unwilling | Contraceptive methods Unable | Childbearing Potential Pregnancy test positive | Postmenopausal state Absent | Female Sterilization Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0558080
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C1299582
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0240802
UMLS CUI [6,1]
C0232970
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0015787
UMLS CUI [7,2]
C0332197
chemotherapy within 4 weeks of starting therapy, or concurrent anticancer therapy (chemotherapy, radiotherapy, or biologic therapy).
Description

Chemotherapy | Cancer treatment | Therapeutic radiology procedure | Biological treatment

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0920425
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
UMLS CUI [5]
C1531518
other malignancy within 3 years except in situ carcinoma.
Description

Cancer Other | Exception Carcinoma in Situ

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007099
unwilling or unable to provide informed consent.
Description

Informed Consent Unwilling | Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
known hypersensitivity to nucleoside analogues.
Description

Hypersensitivity Nucleoside Analogs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1579410
any other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, ventricular arrhythmia, active infection, and known hepatitis.
Description

Other medical condition compromises Safety | Other medical condition compromises Compliance behavior | Other medical condition compromises Completion of clinical trial | Uncontrolled hypertension | Angina, Unstable | Myocardial Infarction | Ventricular arrhythmia | Communicable Disease | Hepatitis

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0036043
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1321605
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C2732579
UMLS CUI [4]
C1868885
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0027051
UMLS CUI [7]
C0085612
UMLS CUI [8]
C0009450
UMLS CUI [9]
C0019158
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Similar models

Eligibility Leukemia NCT00800566

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00800566
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia French-American-British Classification | Prolymphocytic Leukemia French-American-British Classification | Small lymphocytic lymphoma recurrent | Small lymphocytic lymphoma refractory | Prolymphocytic Leukemia Recurrent | Prolymphocytic Leukemia refractory | Therapeutic procedure Based Fludarabine | Therapeutic procedure Quantity
Item
patients with chronic lymphocytic leukemia (cll), cll/pll (as defined by fab [french-american-british classification]), small lymphocytic lymphoma (sll) and prolymphocytic leukemia (pll) who have relapsed from or are refractory to at least one fludarabine-based regimen and no greater than 2 regimens.
boolean
C0023434 (UMLS CUI [1,1])
C2984084 (UMLS CUI [1,2])
C0023486 (UMLS CUI [2,1])
C2984084 (UMLS CUI [2,2])
C0855096 (UMLS CUI [3])
C0855097 (UMLS CUI [4])
C0023486 (UMLS CUI [5,1])
C0277556 (UMLS CUI [5,2])
C0023486 (UMLS CUI [6,1])
C0205269 (UMLS CUI [6,2])
C0087111 (UMLS CUI [7,1])
C1705938 (UMLS CUI [7,2])
C0059985 (UMLS CUI [7,3])
C0087111 (UMLS CUI [8,1])
C1265611 (UMLS CUI [8,2])
Absolute neutrophil count | Platelet Count measurement
Item
absolute neutrophil count (anc) >= 1 x 109/l and platelet count >= 50 x 109/l.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Organ function | Creatinine measurement, serum | Estimated Glomerular Filtration Rate Modification of diet in renal disease formula | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement
Item
adequate organ function as indicated by the following laboratory values: serum creatinine </= 1 mg/dl; if serum creatinine > 1 mg/dl, then the estimated glomerular filtration rate (gfr) must be > 60 ml/min/1.73 m2 as calculated by the modification of diet in renal disease equation; serum bilirubin </= 1.5 mg/dl x uln; aspartate transaminase (ast)or alanine transaminase (alt) </= 2.5 x uln; alkaline phosphatase </= 2.5 x uln.
boolean
C0678852 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C3811844 (UMLS CUI [3,1])
C3839656 (UMLS CUI [3,2])
C1278039 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
ECOG performance status
Item
ecog performance status <= 2.
boolean
C1520224 (UMLS CUI [1])
Age
Item
age >/= 18 years.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart Disease New York Heart Association Classification
Item
patients with nyha >/= grade 3 heart disease as assessed by history and/or physical examination.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Contraceptive methods Unwilling | Contraceptive methods Unable | Childbearing Potential Pregnancy test positive | Postmenopausal state Absent | Female Sterilization Absent
Item
pregnant or breastfeeding women or patients who are unwilling or unable to practice adequate contraception. positive pregnancy test for women of child bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0240802 (UMLS CUI [5,2])
C0232970 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0015787 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
Chemotherapy | Cancer treatment | Therapeutic radiology procedure | Biological treatment
Item
chemotherapy within 4 weeks of starting therapy, or concurrent anticancer therapy (chemotherapy, radiotherapy, or biologic therapy).
boolean
C0392920 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
Cancer Other | Exception Carcinoma in Situ
Item
other malignancy within 3 years except in situ carcinoma.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007099 (UMLS CUI [2,2])
Informed Consent Unwilling | Informed Consent Unable
Item
unwilling or unable to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Hypersensitivity Nucleoside Analogs
Item
known hypersensitivity to nucleoside analogues.
boolean
C0020517 (UMLS CUI [1,1])
C1579410 (UMLS CUI [1,2])
Other medical condition compromises Safety | Other medical condition compromises Compliance behavior | Other medical condition compromises Completion of clinical trial | Uncontrolled hypertension | Angina, Unstable | Myocardial Infarction | Ventricular arrhythmia | Communicable Disease | Hepatitis
Item
any other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, ventricular arrhythmia, active infection, and known hepatitis.
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0036043 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C1868885 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
C0085612 (UMLS CUI [7])
C0009450 (UMLS CUI [8])
C0019158 (UMLS CUI [9])
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