ID

36317

Descrição

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

Link

https://clinicaltrials.gov/show/NCT02431403

Palavras-chave

Versões (1)
  1. 03/05/2019 03/05/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

3 de maio de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Lymphoma, Non-Hodgkin NCT02431403

Inglês

Eligibility Lymphoma, Non-Hodgkin NCT02431403

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

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

Tipo de dados

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
Descrição

Paraffin Embedded Tissue Lesion Available | Immunohistochemistry

Tipo de dados

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
Descrição

Patient Appropriate ESHAP regimen

Tipo de dados

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
Descrição

Lesion Quantity Diameter

Tipo de dados

boolean

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

Age

Tipo de dados

boolean

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

ECOG performance status

Tipo de dados

boolean

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

Renal function | Creatinine measurement, serum | Creatinine clearance measurement

Tipo de dados

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.
Descrição

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

Tipo de dados

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 ≥
Descrição

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Tipo de dados

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
Descrição

Hemoglobin measurement

Tipo de dados

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
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

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

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

Tipo de dados

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
Descrição

Hypersensitivity Imatinib | Hypersensitivity Suspected Imatinib

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

Central Nervous System Involvement with Lymphoma

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

HIV Seropositivity Treating

Tipo de dados

boolean

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

Eligibility Lymphoma, Non-Hodgkin NCT02431403

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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