ID

32509

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00684411

Trefwoorden

Versies (1)
  1. 05-11-18 05-11-18 -
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See clinicaltrials.gov

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5 november 2018

DOI

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

Engels

Eligibility T Cell Non-Hodgkin Lymphoma NCT00684411

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Age

Datatype

boolean

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

Life Expectancy

Datatype

boolean

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

ECOG performance status

Datatype

boolean

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

Organ function | Bone Marrow function

Datatype

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
Beschrijving

Agreement Use of Contraceptive methods

Datatype

boolean

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

Exclusion Criteria

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

Chemotherapy | Therapeutic radiology procedure

Datatype

boolean

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

Investigational New Drugs

Datatype

boolean

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

Central nervous system lymphoma Treatment required for

Datatype

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
Beschrijving

Allergic Reaction Compound Imatinib mesylate Similar

Datatype

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
Beschrijving

Patient need for CYP3A4 Inhibitors | Patient need for CYP3A4 Inducers

Datatype

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
Beschrijving

Prior radiation therapy Bone Marrow Percentage

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Pregnancy | Breast Feeding

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Antiretroviral therapy Combination HIV Seropositivity

Datatype

boolean

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

Chronic liver disease

Datatype

boolean

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

Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
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Similar models

Eligibility T Cell Non-Hodgkin Lymphoma NCT00684411

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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