ID

20114

Beschreibung

Study of Weekly Motexafin Gadolinium (MGd) for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00290004

Link

https://clinicaltrials.gov/show/NCT00290004

Stichworte

Versionen (1)
  1. 07.02.17 07.02.17 -
Hochgeladen am

7. Februar 2017

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00290004

Englisch

Eligibility Chronic Lymphocytic Leukemia NCT00290004

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
≥ 18 years old
Beschreibung

Age

Datentyp

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:
Beschreibung

Chronic Lymphocytic Leukemia | Surface immunoglobulins Staining Clear | t(11;14)(q13;q32) Negative | Cyclin D1 Negative | B-cell small lymphocytic lymphoma refractory | B-cell small lymphocytic lymphoma recurrent

Datentyp

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2,1]
C0034789
UMLS CUI [2,2]
C1704680
UMLS CUI [2,3]
C2963144
UMLS CUI [3,1]
C1515705
UMLS CUI [3,2]
C1513916
UMLS CUI [4,1]
C0174680
UMLS CUI [4,2]
C1513916
UMLS CUI [5]
C0855097
UMLS CUI [6]
C0855096
refractory disease: progressive disease while on therapy
Beschreibung

Refractory Disease | Progressive Disease while Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1514815
UMLS CUI [2,1]
C1335499
UMLS CUI [2,2]
C0750519
UMLS CUI [2,3]
C0087111
relapsed disease: progressive disease after at least one treatment course of therapy with disease response or stabilization
Beschreibung

Recurrent disease | Therapeutic procedure Course Quantity Disease Response | Therapeutic procedure Course Quantity Disease Stabilization | Progressive Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C1704632
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0750729
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0012634
UMLS CUI [3,5]
C1293130
UMLS CUI [4]
C1335499
ecog performance status score of 0, 1, or 2
Beschreibung

ECOG performance status

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
laboratory values of:
Beschreibung

Laboratory Results

Datentyp

boolean

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

Platelet Count measurement

Datentyp

boolean

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

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

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

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
creatinine > 2 mg/dl
Beschreibung

Creatinine measurement, serum

Datentyp

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
Beschreibung

Chemotherapy Malignant Neoplasms | Therapeutic radiology procedure Malignant Neoplasms | Immunotherapy Malignant Neoplasms | CORTICOSTEROIDS FOR SYSTEMIC USE Malignant Neoplasms | Prednisone Oral Dose | Prednisone Oral Equivalent Dose | Biological treatment Systemic Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0006826
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0006826
UMLS CUI [4,1]
C3653708
UMLS CUI [4,2]
C0006826
UMLS CUI [5,1]
C3216040
UMLS CUI [5,2]
C0178602
UMLS CUI [6,1]
C3216040
UMLS CUI [6,2]
C0205163
UMLS CUI [6,3]
C0178602
UMLS CUI [7,1]
C1531518
UMLS CUI [7,2]
C0205373
UMLS CUI [7,3]
C0006826
major surgery or hospitalization for a serious illness within the last 3 months
Beschreibung

Major surgery Illness Serious | Hospitalization Illness Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0221423
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0221423
UMLS CUI [2,3]
C0205404
greater than three prior regimens (where a regimen is defined as a treatment for cll/sll given initially or after disease progression)
Beschreibung

Regimen Quantity | Therapeutic procedure Initial Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Therapeutic procedure Post Disease Progression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205265
UMLS CUI [2,3]
C1302547
UMLS CUI [3,1]
C1302547
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0687676
UMLS CUI [3,4]
C0242656
prior malignancy requiring current or prior treatment within the past 5 years, except for cervical neoplasia in situ and non-melanomatous skin cancer
Beschreibung

Malignant Neoplasms Requirement Therapeutic procedure | Carcinoma in situ of uterine cervix | Skin carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C0851140
UMLS CUI [3]
C0699893
uncontrolled hypertension
Beschreibung

Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
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Ähnliche Modelle

Eligibility Chronic Lymphocytic Leukemia NCT00290004

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
≥ 18 years old
boolean
C0001779 (UMLS CUI [1])
Chronic Lymphocytic Leukemia | Surface immunoglobulins Staining Clear | t(11;14)(q13;q32) Negative | Cyclin D1 Negative | B-cell small lymphocytic lymphoma refractory | B-cell small lymphocytic lymphoma recurrent
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:
boolean
C0023434 (UMLS CUI [1])
C0034789 (UMLS CUI [2,1])
C1704680 (UMLS CUI [2,2])
C2963144 (UMLS CUI [2,3])
C1515705 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C0174680 (UMLS CUI [4,1])
C1513916 (UMLS CUI [4,2])
C0855097 (UMLS CUI [5])
C0855096 (UMLS CUI [6])
Refractory Disease | Progressive Disease while Therapeutic procedure
Item
refractory disease: progressive disease while on therapy
boolean
C1514815 (UMLS CUI [1])
C1335499 (UMLS CUI [2,1])
C0750519 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Recurrent disease | Therapeutic procedure Course Quantity Disease Response | Therapeutic procedure Course Quantity Disease Stabilization | Progressive Disease
Item
relapsed disease: progressive disease after at least one treatment course of therapy with disease response or stabilization
boolean
C0277556 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1704632 (UMLS CUI [2,4])
C0087111 (UMLS CUI [3,1])
C0750729 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0012634 (UMLS CUI [3,4])
C1293130 (UMLS CUI [3,5])
C1335499 (UMLS CUI [4])
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])
Serum total bilirubin measurement
Item
total bilirubin > 2 x uln
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine > 2 mg/dl
boolean
C0201976 (UMLS CUI [1])
Chemotherapy Malignant Neoplasms | Therapeutic radiology procedure Malignant Neoplasms | Immunotherapy Malignant Neoplasms | CORTICOSTEROIDS FOR SYSTEMIC USE Malignant Neoplasms | Prednisone Oral Dose | Prednisone Oral Equivalent Dose | Biological treatment Systemic Malignant Neoplasms
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 [1,1])
C0006826 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C3653708 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C3216040 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C3216040 (UMLS CUI [6,1])
C0205163 (UMLS CUI [6,2])
C0178602 (UMLS CUI [6,3])
C1531518 (UMLS CUI [7,1])
C0205373 (UMLS CUI [7,2])
C0006826 (UMLS CUI [7,3])
Major surgery Illness Serious | Hospitalization Illness Serious
Item
major surgery or hospitalization for a serious illness within the last 3 months
boolean
C0679637 (UMLS CUI [1,1])
C0221423 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2,1])
C0221423 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
Regimen Quantity | Therapeutic procedure Initial Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Therapeutic procedure Post 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
C0040808 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0205265 (UMLS CUI [2,2])
C1302547 (UMLS CUI [2,3])
C1302547 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0687676 (UMLS CUI [3,3])
C0242656 (UMLS CUI [3,4])
Malignant Neoplasms Requirement Therapeutic procedure | Carcinoma in situ of uterine cervix | Skin carcinoma
Item
prior malignancy requiring current or prior treatment within the past 5 years, except for cervical neoplasia in situ and non-melanomatous skin cancer
boolean
C0006826 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0851140 (UMLS CUI [2])
C0699893 (UMLS CUI [3])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
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