ID

32509

Description

Gleevec in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00684411

Link

https://clinicaltrials.gov/show/NCT00684411

Keywords

Versions (1)
  1. 11/5/18 11/5/18 -
Copyright Holder

See clinicaltrials.gov

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November 5, 2018

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License

Creative Commons BY 4.0
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Eligibility T Cell Non-Hodgkin Lymphoma NCT00684411

English

Eligibility T Cell Non-Hodgkin Lymphoma NCT00684411

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed t nhl, excluding t prolymphocytic leukemia, t lymphoblastic lymphoma, and t/nk large granular lymphocytic leukemia.
Description

T-Cell Lymphoma | Exception T-Cell Prolymphocytic Leukemia | Exception Lymphoblastic T-cell lymphoma | Exception T-Cell Large Granular Lymphocyte Leukemia | Exception Natural Killer Cell Large Granular Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0079772
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2363142
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2853920
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1955861
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1955860
measurable disease, defined as at least one bidimensionally measurable site of disease measuring at least 1.5cm in greatest diameter.
Description

Measurable Disease | Anatomic Site Quantity Measurable 2-Dimensional | Anatomic Site Measurable Greatest Diameter

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1513040
UMLS CUI [2,4]
C1705052
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C1513040
UMLS CUI [3,3]
C0552406
failed at least one systemic chemotherapy or biologic therapy for t cell lymphoma unless it can be clearly documented that the patient can not tolerate such therapy.
Description

Systemic Chemotherapy Quantity failed T-Cell Lymphoma | Biological treatment Quantity failed T-Cell Lymphoma | Exception Intolerance Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
UMLS CUI [1,4]
C0079772
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
UMLS CUI [2,4]
C0079772
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0231199
UMLS CUI [3,3]
C0087111
18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy of greater than 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status of lesser then or equal to 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
normal organ and marrow function as outlined in the protocol
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
agree to the use of adequate contraception prior to study entry and for the duration of the study
Description

Agreement Use of Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
chemotherapy or radiotherapy within 4 weeks prior to entering the study
Description

Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
receiving any other study agents
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
cns lymphoma requiring active therapy
Description

Central nervous system lymphoma Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0742472
UMLS CUI [1,2]
C0332121
history of allergic reactions attributed to compounds of similar chemical or biologic composition to imatinib mesylate
Description

Allergic Reaction Compound Imatinib mesylate Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0939537
UMLS CUI [1,4]
C2348205
participants requiring concomitant administration of any medications or substances that are inhibitors or inducers of cyp3a4 are ineligible
Description

Patient need for CYP3A4 Inhibitors | Patient need for CYP3A4 Inducers

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C3850053
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C3850041
patient previously received radiotherapy to 25% or greater of the bone marrow
Description

Prior radiation therapy Bone Marrow Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Description

Comorbidity | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of a different malignancy except for individuals who have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy
Description

Cancer Other | Exception Patients Disease Free of | Exception Low Risk Recurrent tumor

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C0012634
UMLS CUI [2,4]
C0332296
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3538919
UMLS CUI [3,3]
C0521158
hiv-positive individuals on combination antiretroviral therapy
Description

Antiretroviral therapy Combination HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1,1]
C1963724
UMLS CUI [1,2]
C0205195
UMLS CUI [1,3]
C0019699
known chronic liver disease
Description

Chronic liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0341439
major surgery within 2 weeks prior to study entry
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
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Similar models

Eligibility T Cell Non-Hodgkin Lymphoma NCT00684411

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
T-Cell Lymphoma | Exception T-Cell Prolymphocytic Leukemia | Exception Lymphoblastic T-cell lymphoma | Exception T-Cell Large Granular Lymphocyte Leukemia | Exception Natural Killer Cell Large Granular Lymphocytic Leukemia
Item
histologically confirmed t nhl, excluding t prolymphocytic leukemia, t lymphoblastic lymphoma, and t/nk large granular lymphocytic leukemia.
boolean
C0079772 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2363142 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2853920 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1955861 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1955860 (UMLS CUI [5,2])
Measurable Disease | Anatomic Site Quantity Measurable 2-Dimensional | Anatomic Site Measurable Greatest Diameter
Item
measurable disease, defined as at least one bidimensionally measurable site of disease measuring at least 1.5cm in greatest diameter.
boolean
C1513041 (UMLS CUI [1])
C1515974 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1513040 (UMLS CUI [2,3])
C1705052 (UMLS CUI [2,4])
C1515974 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0552406 (UMLS CUI [3,3])
Systemic Chemotherapy Quantity failed T-Cell Lymphoma | Biological treatment Quantity failed T-Cell Lymphoma | Exception Intolerance Therapeutic procedure
Item
failed at least one systemic chemotherapy or biologic therapy for t cell lymphoma unless it can be clearly documented that the patient can not tolerate such therapy.
boolean
C1883256 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0079772 (UMLS CUI [1,4])
C1531518 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0079772 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0231199 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of lesser then or equal to 2
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
normal organ and marrow function as outlined in the protocol
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Agreement Use of Contraceptive methods
Item
agree to the use of adequate contraception prior to study entry and for the duration of the study
boolean
C0680240 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure
Item
chemotherapy or radiotherapy within 4 weeks prior to entering the study
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Investigational New Drugs
Item
receiving any other study agents
boolean
C0013230 (UMLS CUI [1])
Central nervous system lymphoma Treatment required for
Item
cns lymphoma requiring active therapy
boolean
C0742472 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Allergic Reaction Compound Imatinib mesylate Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to imatinib mesylate
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0939537 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Patient need for CYP3A4 Inhibitors | Patient need for CYP3A4 Inducers
Item
participants requiring concomitant administration of any medications or substances that are inhibitors or inducers of cyp3a4 are ineligible
boolean
C0686904 (UMLS CUI [1,1])
C3850053 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C3850041 (UMLS CUI [2,2])
Prior radiation therapy Bone Marrow Percentage
Item
patient previously received radiotherapy to 25% or greater of the bone marrow
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Comorbidity | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other | Exception Patients Disease Free of | Exception Low Risk Recurrent tumor
Item
history of a different malignancy except for individuals who have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
C0332296 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C3538919 (UMLS CUI [3,2])
C0521158 (UMLS CUI [3,3])
Antiretroviral therapy Combination HIV Seropositivity
Item
hiv-positive individuals on combination antiretroviral therapy
boolean
C1963724 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C0019699 (UMLS CUI [1,3])
Chronic liver disease
Item
known chronic liver disease
boolean
C0341439 (UMLS CUI [1])
Major surgery
Item
major surgery within 2 weeks prior to study entry
boolean
C0679637 (UMLS CUI [1])
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