ID

28049

Description

Study of AMD3100 (Plerixafor) and Rituximab in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00694590

Link

https://clinicaltrials.gov/show/NCT00694590

Keywords

Versions (1)
  1. 12/12/17 12/12/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 12, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia (CLL) NCT00694590

English

Eligibility Chronic Lymphocytic Leukemia (CLL) NCT00694590

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period or be surgically sterile. males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during treatment and for 3 months after the treatment period or be surgically sterile.
Description

Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods | Female Sterilization | Gender | Sexual Abstinence | Contraceptive methods | Male sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0079399
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0700589
UMLS CUI [7]
C0024559
diagnosis of cll or sll, relapsed from at least one prior therapy.
Description

Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | Prior Therapy Quantity | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C0855095
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0277556
cll/sll cells expressing cd20 documented during screening.
Description

CLL Cells CD20 Expression | SLL Cells CD20 Expression

Data type

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0007634
UMLS CUI [1,3]
C0054946
UMLS CUI [1,4]
C0017262
UMLS CUI [2,1]
C0855095
UMLS CUI [2,2]
C0007634
UMLS CUI [2,3]
C0054946
UMLS CUI [2,4]
C0017262
eastern cooperative oncology group (ecog) performance status of ≤2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 12 weeks.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
serum creatinine ≤2.0 mg/dl.
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
total bilirubin ≤2.0 mg/dl.
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
alt (alanine aminotransferase) and ast (aspartate aminotransaminase) ≤2 times the upper limit of normal (uln); for patients with liver involvement of cll/sll disease, this limit is increased to ≤5 times the uln.
Description

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Involvement with CLL/SLL

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3,1]
C0023884
UMLS CUI [3,2]
C1314939
UMLS CUI [3,3]
C1302547
at the time of enrollment, patients must be >4 weeks since major surgery, radiotherapy, chemotherapy (>6 weeks for some chemotherapies), immunotherapy, biotherapy/targeted or investigational therapies and recovered from the toxicity of prior treatment to ≤ grade 1.
Description

Major surgery | Therapeutic radiology procedure | Chemotherapy | Immunotherapy | Biological treatment | Targeted Therapy | Therapy, Investigational | Toxicity Due to Prior Therapy | Patient recovered | Toxicity CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0021083
UMLS CUI [5]
C1531518
UMLS CUI [6]
C2985566
UMLS CUI [7]
C0949266
UMLS CUI [8,1]
C0600688
UMLS CUI [8,2]
C0678226
UMLS CUI [8,3]
C1514463
UMLS CUI [9]
C1115804
UMLS CUI [10,1]
C0600688
UMLS CUI [10,2]
C1516728
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
white blood cells (wbc) >250 x 10^9 cells/l.
Description

White Blood Cell Count

Data type

boolean

Alias
UMLS CUI [1]
C0023508
disease refractory to rituximab therapy- defined as a failure to respond to prior rituximab-containing regimen.
Description

Refractory Disease | Rituximab Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1]
C1514815
UMLS CUI [2,1]
C0393022
UMLS CUI [2,2]
C0205269
women who are breastfeeding.
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
active viral hepatitis.
Description

Viral hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0042721
active infection or treatment with antimicrobial or antiviral therapy within 1 week of enrollment with the exception of prophylactic therapy.
Description

Communicable Disease | Antimicrobial Therapeutic procedure | Antiviral Therapy | Exception Prophylactic treatment

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0003232
UMLS CUI [2,2]
C0087111
UMLS CUI [3]
C0280274
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0199176
history of prior allergic reaction to plerixafor or rituximab.
Description

Allergic Reaction Plerixafor | Allergic Reaction rituximab

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1955474
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0393022
significant lung disease.
Description

Lung disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
serious cardiac disease such as a history of sustained ventricular arrhythmia, uncontrolled and serious congestive heart failure (chf), angina, acute coronary syndrome, or myocardial infarction within 6 months of enrollment or other significant medical or psychosocial conditions that warrants exclusion.
Description

Heart Disease Serious | Ventricular arrhythmia (sustained VT) | Congestive heart failure Serious Uncontrolled | Angina Pectoris | Acute Coronary Syndrome | Myocardial Infarction | Medical condition Study Subject Participation Status Excluded | Psychosocial condition Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C2674344
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0205318
UMLS CUI [4]
C0002962
UMLS CUI [5]
C0948089
UMLS CUI [6]
C0027051
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C2348568
UMLS CUI [7,3]
C2828389
UMLS CUI [8,1]
C0337459
UMLS CUI [8,2]
C2348568
UMLS CUI [8,3]
C2828389
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Similar models

Eligibility Chronic Lymphocytic Leukemia (CLL) NCT00694590

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods | Female Sterilization | Gender | Sexual Abstinence | Contraceptive methods | Male sterilization
Item
females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period or be surgically sterile. males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during treatment and for 3 months after the treatment period or be surgically sterile.
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0015787 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C0700589 (UMLS CUI [6])
C0024559 (UMLS CUI [7])
Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | Prior Therapy Quantity | Recurrent disease
Item
diagnosis of cll or sll, relapsed from at least one prior therapy.
boolean
C0023434 (UMLS CUI [1])
C0855095 (UMLS CUI [2])
C1514463 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0277556 (UMLS CUI [4])
CLL Cells CD20 Expression | SLL Cells CD20 Expression
Item
cll/sll cells expressing cd20 documented during screening.
boolean
C0023434 (UMLS CUI [1,1])
C0007634 (UMLS CUI [1,2])
C0054946 (UMLS CUI [1,3])
C0017262 (UMLS CUI [1,4])
C0855095 (UMLS CUI [2,1])
C0007634 (UMLS CUI [2,2])
C0054946 (UMLS CUI [2,3])
C0017262 (UMLS CUI [2,4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of ≤2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine ≤2.0 mg/dl.
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin ≤2.0 mg/dl.
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Involvement with CLL/SLL
Item
alt (alanine aminotransferase) and ast (aspartate aminotransaminase) ≤2 times the upper limit of normal (uln); for patients with liver involvement of cll/sll disease, this limit is increased to ≤5 times the uln.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0023884 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C1302547 (UMLS CUI [3,3])
Major surgery | Therapeutic radiology procedure | Chemotherapy | Immunotherapy | Biological treatment | Targeted Therapy | Therapy, Investigational | Toxicity Due to Prior Therapy | Patient recovered | Toxicity CTCAE Grades
Item
at the time of enrollment, patients must be >4 weeks since major surgery, radiotherapy, chemotherapy (>6 weeks for some chemotherapies), immunotherapy, biotherapy/targeted or investigational therapies and recovered from the toxicity of prior treatment to ≤ grade 1.
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
C2985566 (UMLS CUI [6])
C0949266 (UMLS CUI [7])
C0600688 (UMLS CUI [8,1])
C0678226 (UMLS CUI [8,2])
C1514463 (UMLS CUI [8,3])
C1115804 (UMLS CUI [9])
C0600688 (UMLS CUI [10,1])
C1516728 (UMLS CUI [10,2])
Item Group
C0680251 (UMLS CUI)
White Blood Cell Count
Item
white blood cells (wbc) >250 x 10^9 cells/l.
boolean
C0023508 (UMLS CUI [1])
Refractory Disease | Rituximab Unresponsive to Treatment
Item
disease refractory to rituximab therapy- defined as a failure to respond to prior rituximab-containing regimen.
boolean
C1514815 (UMLS CUI [1])
C0393022 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Breast Feeding
Item
women who are breastfeeding.
boolean
C0006147 (UMLS CUI [1])
Viral hepatitis
Item
active viral hepatitis.
boolean
C0042721 (UMLS CUI [1])
Communicable Disease | Antimicrobial Therapeutic procedure | Antiviral Therapy | Exception Prophylactic treatment
Item
active infection or treatment with antimicrobial or antiviral therapy within 1 week of enrollment with the exception of prophylactic therapy.
boolean
C0009450 (UMLS CUI [1])
C0003232 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0280274 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0199176 (UMLS CUI [4,2])
Allergic Reaction Plerixafor | Allergic Reaction rituximab
Item
history of prior allergic reaction to plerixafor or rituximab.
boolean
C1527304 (UMLS CUI [1,1])
C1955474 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0393022 (UMLS CUI [2,2])
Lung disease
Item
significant lung disease.
boolean
C0024115 (UMLS CUI [1])
Heart Disease Serious | Ventricular arrhythmia (sustained VT) | Congestive heart failure Serious Uncontrolled | Angina Pectoris | Acute Coronary Syndrome | Myocardial Infarction | Medical condition Study Subject Participation Status Excluded | Psychosocial condition Study Subject Participation Status Excluded
Item
serious cardiac disease such as a history of sustained ventricular arrhythmia, uncontrolled and serious congestive heart failure (chf), angina, acute coronary syndrome, or myocardial infarction within 6 months of enrollment or other significant medical or psychosocial conditions that warrants exclusion.
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2674344 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0002962 (UMLS CUI [4])
C0948089 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
C3843040 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
C2828389 (UMLS CUI [7,3])
C0337459 (UMLS CUI [8,1])
C2348568 (UMLS CUI [8,2])
C2828389 (UMLS CUI [8,3])
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