ID

16683

Descripción

Study of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00100711

Link

https://clinicaltrials.gov/show/NCT00100711

Palabras clave

Versiones (1)
  1. 1/8/16 1/8/16 -
Subido en

1 de agosto de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00100711

Inglés

Eligibility Chronic Lymphocytic Leukemia NCT00100711

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
≥ 18 years old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
cll as defined by the nci 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t[11;14] translocation or cyclin d1) or sll as defined by who classification criteria and is refractory or relapsed as defined by one of the following: 1) refractory disease- progressive disease while on therapy, or 2) relapsed disease progressive disease after at least one treatment course of therapy with disease response or stabilization
Descripción

Chronic Lymphocytic Leukemia | Surface Immunoglobulins Staining | t(11;14)(q13;q32) Negative | Cyclin D1 Negative | Therapeutic procedure Small Lymphocytic Lymphoma | Refractory Disease | Progressive Disease | Recurrent disease | Therapeutic procedure Disease Response | Therapeutic procedure Stabilization | Progressive Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2,1]
C0034789
UMLS CUI [2,2]
C1704680
UMLS CUI [3,1]
C1515705
UMLS CUI [3,2]
C0205160
UMLS CUI [4,1]
C0174680
UMLS CUI [4,2]
C0205160
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0855095
UMLS CUI [6]
C1514815
UMLS CUI [7]
C1335499
UMLS CUI [8]
C0277556
UMLS CUI [9,1]
C0087111
UMLS CUI [9,2]
C1704632
UMLS CUI [10,1]
C0087111
UMLS CUI [10,2]
C1293130
UMLS CUI [11]
C1335499
ecog performance status score of 0, 1, or 2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
willing and able to provide written informed consent
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
laboratory values of:
Descripción

Laboratory Results

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1254595
platelet count < 30,000/µl
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
ast or alt > 2 x uln (upper limit of normal)
Descripción

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
total bilirubin > 2 x uln
Descripción

Bilirubin, total measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201913
creatinine > 2.0 mg/dl
Descripción

Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment
Descripción

Chemotherapy | Therapeutic radiology procedure | Immunotherapy | systemic steroids | Prednisone Oral Product | cancer treatment biological Systemic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
UMLS CUI [4]
C2825233
UMLS CUI [5]
C3216040
UMLS CUI [6,1]
C0920425
UMLS CUI [6,2]
C0205460
UMLS CUI [6,3]
C0205373
greater than three prior regimens (where a regimen is defined as a treatment for cll/sll given initially or after disease progression)
Descripción

Therapeutic procedure Chronic Lymphocytic Leukemia | Therapeutic procedure Small Lymphocytic Lymphoma | Disease Progression

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0023434
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0855095
UMLS CUI [3]
C0242656
uncontrolled hypertension
Descripción

Uncontrolled hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1868885
known history of porphyria (testing not required at screening)
Descripción

Porphyria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3463940
known history of glucose-6-phosphate dehydrogenase (g6pd) deficiency (testing not required at screening)
Descripción

Deficiency of glucose-6-phosphate dehydrogenase

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2939465
known history of hiv infection (testing not required at screening)
Descripción

HIV Infections

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
Descripción

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy Test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032976
woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection
Descripción

Childbearing Potential Contraceptive methods Unwilling | Gender Sexually active Contraceptive methods Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
UMLS CUI [2,4]
C0558080
physical or mental condition that makes patient unable to complete specified follow-up assessments
Descripción

Physical Condition Follow-up Unable | Mental condition Follow-up Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3714565
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C3274571
UMLS CUI [2,3]
C1299582
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00100711

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
≥ 18 years old
boolean
C0001779 (UMLS CUI [1])
Chronic Lymphocytic Leukemia | Surface Immunoglobulins Staining | t(11;14)(q13;q32) Negative | Cyclin D1 Negative | Therapeutic procedure Small Lymphocytic Lymphoma | Refractory Disease | Progressive Disease | Recurrent disease | Therapeutic procedure Disease Response | Therapeutic procedure Stabilization | Progressive Disease
Item
cll as defined by the nci 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t[11;14] translocation or cyclin d1) or sll as defined by who classification criteria and is refractory or relapsed as defined by one of the following: 1) refractory disease- progressive disease while on therapy, or 2) relapsed disease progressive disease after at least one treatment course of therapy with disease response or stabilization
boolean
C0023434 (UMLS CUI [1])
C0034789 (UMLS CUI [2,1])
C1704680 (UMLS CUI [2,2])
C1515705 (UMLS CUI [3,1])
C0205160 (UMLS CUI [3,2])
C0174680 (UMLS CUI [4,1])
C0205160 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C0855095 (UMLS CUI [5,2])
C1514815 (UMLS CUI [6])
C1335499 (UMLS CUI [7])
C0277556 (UMLS CUI [8])
C0087111 (UMLS CUI [9,1])
C1704632 (UMLS CUI [9,2])
C0087111 (UMLS CUI [10,1])
C1293130 (UMLS CUI [10,2])
C1335499 (UMLS CUI [11])
ECOG performance status
Item
ecog performance status score of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Informed consent
Item
willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Laboratory Results
Item
laboratory values of:
boolean
C1254595 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 30,000/µl
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast or alt > 2 x uln (upper limit of normal)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Bilirubin, total measurement
Item
total bilirubin > 2 x uln
boolean
C0201913 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine > 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | systemic steroids | Prednisone Oral Product | cancer treatment biological Systemic
Item
chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C2825233 (UMLS CUI [4])
C3216040 (UMLS CUI [5])
C0920425 (UMLS CUI [6,1])
C0205460 (UMLS CUI [6,2])
C0205373 (UMLS CUI [6,3])
Therapeutic procedure Chronic Lymphocytic Leukemia | Therapeutic procedure Small Lymphocytic Lymphoma | Disease Progression
Item
greater than three prior regimens (where a regimen is defined as a treatment for cll/sll given initially or after disease progression)
boolean
C0087111 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0855095 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Porphyria
Item
known history of porphyria (testing not required at screening)
boolean
C3463940 (UMLS CUI [1])
Deficiency of glucose-6-phosphate dehydrogenase
Item
known history of glucose-6-phosphate dehydrogenase (g6pd) deficiency (testing not required at screening)
boolean
C2939465 (UMLS CUI [1])
HIV Infections
Item
known history of hiv infection (testing not required at screening)
boolean
C0019693 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy Test
Item
pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
Childbearing Potential Contraceptive methods Unwilling | Gender Sexually active Contraceptive methods Unwilling
Item
woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
Physical Condition Follow-up Unable | Mental condition Follow-up Unable
Item
physical or mental condition that makes patient unable to complete specified follow-up assessments
boolean
C3714565 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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