ID

36317

Beskrivning

ESHAP-Imatinib for Refractory/Relapsed Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02431403

Länk

https://clinicaltrials.gov/show/NCT02431403

Nyckelord

Versioner (1)
  1. 2019-05-03 2019-05-03 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

3 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Lymphoma, Non-Hodgkin NCT02431403

Engelsk

Eligibility Lymphoma, Non-Hodgkin NCT02431403

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically diagnosed non-hodgkin's lymphoma, refractory or relapsed after 1st line treatment.
Beskrivning

Non-Hodgkin's lymphoma refractory | Recurrent Non-Hodgkin Lymphoma | Status post First line treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0854867
UMLS CUI [2]
C0854866
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1708063
2. paraffin block of the lesions available for immunohistochemical analysis
Beskrivning

Paraffin Embedded Tissue Lesion Available | Immunohistochemistry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519524
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0470187
UMLS CUI [2]
C0021044
3. candidate for eshap salvage therapy
Beskrivning

Patient Appropriate ESHAP regimen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0384397
4. evidence of at least one lesion with a diameter of 1.5 cm
Beskrivning

Lesion Quantity Diameter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1301886
5. age of over 20 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
6. eastern cooperative oncology group performance status (ecog) less than or equal to 2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
7. adequate kidney function with serum creatinine< 2.5 mg/dl, creatinine clearance ≥ 50 ml/min
Beskrivning

Renal function | Creatinine measurement, serum | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
8. adequate liver function with aspartate transaminase (ast)/alanine aminotransferase (alt) lower than or equal to 3 times the normal upper limit; total bilirubin lower than or equal to 1.5 times the upper limit ;alkaline phosphatase lower than or equal to 5 times the normal upper limit.
Beskrivning

Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Alkaline phosphatase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201850
9. adequate bone marrow function with absolute neutrophil count ≥ 1,000/ul; platelets ≥
Beskrivning

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
75,000/ul; hemoglobin ≥ 9.0 g/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
10. patients who gave voluntarily informed consent before performing any test test that is not part of routine care of patients
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with history of exposure to imatinib or other bcr-abl tyrosine-kinase inhibitors
Beskrivning

Exposure to Imatinib | Exposure to Bcr-Abl Tyrosine Kinase Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0935989
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C2267122
2. known or suspected hypersensitivity to imatinib
Beskrivning

Hypersensitivity Imatinib | Hypersensitivity Suspected Imatinib

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0935989
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0935989
3. potential use or usage alteration of cyp3a4 inducers or inhibitors from prior to 21 days of to the test regimen until the initiation of round 2 eshap. exceptions are itraconazole and fluconazole for treatment or prevention of fungal infection, hydrocortisone and dexamethasone for treatment of nausea/vomiting/fluid retention, and methylprednisolone as a part of the eshap regimen.
Beskrivning

CYP3A4 Inducers | CYP3A4 Inhibitors | Exception Itraconazole | Exception Fluconazole | Therapy Mycoses | Prophylactic treatment Mycoses | Exception Hydrocortisone | Exception Dexamethasone | Therapy Nausea | Therapy Vomiting | Therapy Body fluid retention | Exception Methylprednisolone

Datatyp

boolean

Alias
UMLS CUI [1]
C3850041
UMLS CUI [2]
C3850053
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0064113
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0016277
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0026946
UMLS CUI [6,1]
C0199176
UMLS CUI [6,2]
C0026946
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0020268
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0011777
UMLS CUI [9,1]
C0087111
UMLS CUI [9,2]
C0027497
UMLS CUI [10,1]
C0087111
UMLS CUI [10,2]
C0042963
UMLS CUI [11,1]
C0087111
UMLS CUI [11,2]
C0268000
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C0025815
4. known involvement of the central nervous system (cns) by lymphoma.
Beskrivning

Central Nervous System Involvement with Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0024299
5. pregnant or breast-feeding. females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial.
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy Tests Unwilling | Childbearing Potential Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032976
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0558080
6. serious or uncontrolled medical condition, such as presence of abnormal or clinically significant cardiac disease, such as acute myocardial infarction or unstable angina within 6 months prior to initiation of treatment with eshap-imatinib, serious neurological or psychological conditions such as dementia or epilepsy, or uncontrolled active infection.
Beskrivning

Medical condition Serious | Medical condition Uncontrolled | Heart Disease | Myocardial Infarction | Angina, Unstable | Nervous system disorder Serious | Mental condition Serious | Dementia | Epilepsy | Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0002965
UMLS CUI [6,1]
C0027765
UMLS CUI [6,2]
C0205404
UMLS CUI [7,1]
C3840291
UMLS CUI [7,2]
C0205404
UMLS CUI [8]
C0497327
UMLS CUI [9]
C0014544
UMLS CUI [10,1]
C0009450
UMLS CUI [10,2]
C0205318
7. prior history of malignancy other than to non-hodgkin's lymphoma (except basal or squamous cell skin and in situ carcinoma of the cervix) unless the patient free of disease beyond 5 years are.
Beskrivning

Malignant Neoplasms | Exception Non-Hodgkin Lymphoma | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Disease Free Duration

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0024305
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C0332296
UMLS CUI [6,4]
C0449238
8. hiv positive and in treatment.
Beskrivning

HIV Seropositivity Treating

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019699
UMLS CUI [1,2]
C1522326
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Similar models

Eligibility Lymphoma, Non-Hodgkin NCT02431403

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Hodgkin's lymphoma refractory | Recurrent Non-Hodgkin Lymphoma | Status post First line treatment
Item
1. histologically diagnosed non-hodgkin's lymphoma, refractory or relapsed after 1st line treatment.
boolean
C0854867 (UMLS CUI [1])
C0854866 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1708063 (UMLS CUI [3,2])
Paraffin Embedded Tissue Lesion Available | Immunohistochemistry
Item
2. paraffin block of the lesions available for immunohistochemical analysis
boolean
C1519524 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0021044 (UMLS CUI [2])
Patient Appropriate ESHAP regimen
Item
3. candidate for eshap salvage therapy
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0384397 (UMLS CUI [1,3])
Lesion Quantity Diameter
Item
4. evidence of at least one lesion with a diameter of 1.5 cm
boolean
C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Age
Item
5. age of over 20 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
6. eastern cooperative oncology group performance status (ecog) less than or equal to 2.
boolean
C1520224 (UMLS CUI [1])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
7. adequate kidney function with serum creatinine< 2.5 mg/dl, creatinine clearance ≥ 50 ml/min
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Alkaline phosphatase measurement
Item
8. adequate liver function with aspartate transaminase (ast)/alanine aminotransferase (alt) lower than or equal to 3 times the normal upper limit; total bilirubin lower than or equal to 1.5 times the upper limit ;alkaline phosphatase lower than or equal to 5 times the normal upper limit.
boolean
C0232741 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
9. adequate bone marrow function with absolute neutrophil count ≥ 1,000/ul; platelets ≥
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Hemoglobin measurement
Item
75,000/ul; hemoglobin ≥ 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Informed Consent
Item
10. patients who gave voluntarily informed consent before performing any test test that is not part of routine care of patients
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exposure to Imatinib | Exposure to Bcr-Abl Tyrosine Kinase Inhibitors
Item
1. patients with history of exposure to imatinib or other bcr-abl tyrosine-kinase inhibitors
boolean
C0332157 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C2267122 (UMLS CUI [2,2])
Hypersensitivity Imatinib | Hypersensitivity Suspected Imatinib
Item
2. known or suspected hypersensitivity to imatinib
boolean
C0020517 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0935989 (UMLS CUI [2,3])
CYP3A4 Inducers | CYP3A4 Inhibitors | Exception Itraconazole | Exception Fluconazole | Therapy Mycoses | Prophylactic treatment Mycoses | Exception Hydrocortisone | Exception Dexamethasone | Therapy Nausea | Therapy Vomiting | Therapy Body fluid retention | Exception Methylprednisolone
Item
3. potential use or usage alteration of cyp3a4 inducers or inhibitors from prior to 21 days of to the test regimen until the initiation of round 2 eshap. exceptions are itraconazole and fluconazole for treatment or prevention of fungal infection, hydrocortisone and dexamethasone for treatment of nausea/vomiting/fluid retention, and methylprednisolone as a part of the eshap regimen.
boolean
C3850041 (UMLS CUI [1])
C3850053 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0064113 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0016277 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C0026946 (UMLS CUI [5,2])
C0199176 (UMLS CUI [6,1])
C0026946 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0020268 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0011777 (UMLS CUI [8,2])
C0087111 (UMLS CUI [9,1])
C0027497 (UMLS CUI [9,2])
C0087111 (UMLS CUI [10,1])
C0042963 (UMLS CUI [10,2])
C0087111 (UMLS CUI [11,1])
C0268000 (UMLS CUI [11,2])
C1705847 (UMLS CUI [12,1])
C0025815 (UMLS CUI [12,2])
Central Nervous System Involvement with Lymphoma
Item
4. known involvement of the central nervous system (cns) by lymphoma.
boolean
C3714787 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy Tests Unwilling | Childbearing Potential Contraceptive methods Unwilling
Item
5. pregnant or breast-feeding. females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Medical condition Serious | Medical condition Uncontrolled | Heart Disease | Myocardial Infarction | Angina, Unstable | Nervous system disorder Serious | Mental condition Serious | Dementia | Epilepsy | Communicable Disease Uncontrolled
Item
6. serious or uncontrolled medical condition, such as presence of abnormal or clinically significant cardiac disease, such as acute myocardial infarction or unstable angina within 6 months prior to initiation of treatment with eshap-imatinib, serious neurological or psychological conditions such as dementia or epilepsy, or uncontrolled active infection.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0027765 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C3840291 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
C0497327 (UMLS CUI [8])
C0014544 (UMLS CUI [9])
C0009450 (UMLS CUI [10,1])
C0205318 (UMLS CUI [10,2])
Malignant Neoplasms | Exception Non-Hodgkin Lymphoma | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Disease Free Duration
Item
7. prior history of malignancy other than to non-hodgkin's lymphoma (except basal or squamous cell skin and in situ carcinoma of the cervix) unless the patient free of disease beyond 5 years are.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0024305 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
C0449238 (UMLS CUI [6,4])
HIV Seropositivity Treating
Item
8. hiv positive and in treatment.
boolean
C0019699 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
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