ID

34886

Beschreibung

A Study Evaluating CPI-1205 in Patients With B-Cell Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT02395601

Link

https://clinicaltrials.gov/show/NCT02395601

Stichworte

Versionen (1)
  1. 02.02.19 02.02.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

2. Februar 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility B-Cell Lymphoma NCT02395601

Englisch

Eligibility B-Cell Lymphoma NCT02395601

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults (aged ≥ 18 years)
Beschreibung

Adult | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
histologically confirmed diagnosis of a b-cell lymphoma that has progressed in spite of prior treatment, and for which additional effective standard therapy is not available
Beschreibung

B-Cell Lymphoma | Prior Therapy | Disease Progression | Standard therapy Effective Lacking

Datentyp

boolean

Alias
UMLS CUI [1]
C0079731
UMLS CUI [2]
C1514463
UMLS CUI [3]
C0242656
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C1280519
UMLS CUI [4,3]
C0332268
eastern cooperative oncology group (ecog) performance status ≤ 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematological, renal, hepatic, and coagulation laboratory assessments
Beschreibung

Laboratory Procedures Hematologic function | Laboratory Procedures Renal function | Laboratory Procedures Liver function | Laboratory Procedures Blood coagulation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0221130
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C0232804
UMLS CUI [3,1]
C0022885
UMLS CUI [3,2]
C0232741
UMLS CUI [4,1]
C0022885
UMLS CUI [4,2]
C0005778
must give written informed consent to participate in this study before the performance of any study-related procedure
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
a primary lymphoma of the central nervous system (cns) or known lymphomatous involvement of the cns
Beschreibung

Primary central nervous system lymphoma | Central Nervous System Involvement Lymphomatous

Datentyp

boolean

Alias
UMLS CUI [1]
C0280803
UMLS CUI [2,1]
C4050309
UMLS CUI [2,2]
C0024299
impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of cpi-1205, including any unresolved nausea, vomiting, or diarrhea that is ctcae grade >1
Beschreibung

Impaired gastrointestinal system function Changing Absorption CPI-1205 | Gastrointestinal Disease Changing Absorption CPI-1205 | Nausea CTCAE Grades | Vomiting CTCAE Grades | Diarrhea CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232459
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C4053654
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C4053654
UMLS CUI [3,1]
C0027497
UMLS CUI [3,2]
C1516728
UMLS CUI [4,1]
C0042963
UMLS CUI [4,2]
C1516728
UMLS CUI [5,1]
C0011991
UMLS CUI [5,2]
C1516728
treatment with proton pump inhibitors, h2 antagonists, or antacids
Beschreibung

Proton Pump Inhibitors | H2 Antagonists | Antacids

Datentyp

boolean

Alias
UMLS CUI [1]
C0358591
UMLS CUI [2]
C0019593
UMLS CUI [3]
C0003138
achlorhydria, either documented or suspected on the basis of an associated disease (e.g., pernicious anemia, atrophic gastritis, or certain gastric surgical procedures)
Beschreibung

Achlorhydria | Achlorhydria Suspected Due to Comorbidity | Anemia, Pernicious | Gastritis, Atrophic | Operation on stomach

Datentyp

boolean

Alias
UMLS CUI [1]
C0001075
UMLS CUI [2,1]
C0001075
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0009488
UMLS CUI [3]
C0002892
UMLS CUI [4]
C0017154
UMLS CUI [5]
C0192398
impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Beschreibung

Decreased cardiac function | Heart Diseases Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1]
C0232166
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C2826293
acute myocardial infarction or angina pectoris ≤ 6 months prior to starting study drug
Beschreibung

Myocardial Infarction | Angina Pectoris

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002962
new york heart association class iii or iv congestive heart failure
Beschreibung

Congestive heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
qtcf > 470 msec on the screening ecg
Beschreibung

QTcF Prolongation ECG

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3828431
UMLS CUI [1,2]
C0013798
uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded)
Beschreibung

Cardiac Arrhythmia Uncontrolled | ATRIAL FIBRILLATION VENTRICULAR RATE CONTROLLED allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0741286
UMLS CUI [2,2]
C0683607
a past medical history of other clinically significant cardiovascular disease (e.g., uncontrolled hypertension, history of labile hypertension or history of poor compliance with an antihypertensive regimen)
Beschreibung

Cardiovascular Disease Medical History | Uncontrolled hypertension | Labile hypertension | Antihypertensive therapy Poor compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C1868885
UMLS CUI [3]
C3665418
UMLS CUI [4,1]
C0585941
UMLS CUI [4,2]
C0032646
any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
Beschreibung

Comorbidity Severe compromises Study Subject Participation Status | Comorbidity Uncontrolled compromises Study Subject Participation Status | Lung diseases | Nervous system disorder | Communicable Disease | Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C2348568
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0009450
UMLS CUI [6,1]
C0009450
UMLS CUI [6,2]
C0205318
systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of cpi 1205
Beschreibung

Cancer treatment Systemic | Therapeutic radiology procedure Systemic | Status pre- CPI-1205 Dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C4053654
UMLS CUI [3,3]
C0178602
radioimmunotherapy (e.g., 131i-tositumomab, 90y-ibritumomab tiuxetan) less than 6 weeks before the first dose of cpi-1205
Beschreibung

Radioimmunotherapy | iodine-131-tositumomab | yttrium-90-ibritumomab tiuxetan | Status pre- CPI-1205 Dose

Datentyp

boolean

Alias
UMLS CUI [1]
C0085101
UMLS CUI [2]
C0768182
UMLS CUI [3]
C1134535
UMLS CUI [4,1]
C0332152
UMLS CUI [4,2]
C4053654
UMLS CUI [4,3]
C0178602
treatment with an investigational small molecule less than 2 weeks before the first dose of cpi-1205.
Beschreibung

Small Molecule Investigational | Status pre- CPI-1205 Dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1328819
UMLS CUI [1,2]
C1517586
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C4053654
UMLS CUI [2,3]
C0178602
treatment with a therapeutic antibody less than 4 weeks before the first dose of cpi-1205.
Beschreibung

Antibody therapy | Status pre- CPI-1205 Dose

Datentyp

boolean

Alias
UMLS CUI [1]
C0281176
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C4053654
UMLS CUI [2,3]
C0178602
treatment with medications that are strong inhibitors of cyp3a4
Beschreibung

CYP3A4 Inhibitor

Datentyp

boolean

Alias
UMLS CUI [1]
C3830624
treatment with medications that are inducers of cyp3a4 enzymes
Beschreibung

CYP3A4 Inducer

Datentyp

boolean

Alias
UMLS CUI [1]
C3830625
treatment with medications that are known to carry a risk of torsades de pointes
Beschreibung

Pharmaceutical Preparations At risk Torsades de Pointes

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0040479
pregnant or lactating women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
Beschreibung

Females & males of reproductive potential Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
patients unwilling or unable to comply with this study protocol
Beschreibung

Protocol Compliance Unwilling | Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
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Ähnliche Modelle

Eligibility B-Cell Lymphoma NCT02395601

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adults (aged ≥ 18 years)
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
B-Cell Lymphoma | Prior Therapy | Disease Progression | Standard therapy Effective Lacking
Item
histologically confirmed diagnosis of a b-cell lymphoma that has progressed in spite of prior treatment, and for which additional effective standard therapy is not available
boolean
C0079731 (UMLS CUI [1])
C1514463 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
C2936643 (UMLS CUI [4,1])
C1280519 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Laboratory Procedures Hematologic function | Laboratory Procedures Renal function | Laboratory Procedures Liver function | Laboratory Procedures Blood coagulation
Item
adequate hematological, renal, hepatic, and coagulation laboratory assessments
boolean
C0022885 (UMLS CUI [1,1])
C0221130 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C0232804 (UMLS CUI [2,2])
C0022885 (UMLS CUI [3,1])
C0232741 (UMLS CUI [3,2])
C0022885 (UMLS CUI [4,1])
C0005778 (UMLS CUI [4,2])
Informed Consent
Item
must give written informed consent to participate in this study before the performance of any study-related procedure
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Primary central nervous system lymphoma | Central Nervous System Involvement Lymphomatous
Item
a primary lymphoma of the central nervous system (cns) or known lymphomatous involvement of the cns
boolean
C0280803 (UMLS CUI [1])
C4050309 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])
Impaired gastrointestinal system function Changing Absorption CPI-1205 | Gastrointestinal Disease Changing Absorption CPI-1205 | Nausea CTCAE Grades | Vomiting CTCAE Grades | Diarrhea CTCAE Grades
Item
impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of cpi-1205, including any unresolved nausea, vomiting, or diarrhea that is ctcae grade >1
boolean
C0232459 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C4053654 (UMLS CUI [1,4])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C4053654 (UMLS CUI [2,4])
C0027497 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
C0042963 (UMLS CUI [4,1])
C1516728 (UMLS CUI [4,2])
C0011991 (UMLS CUI [5,1])
C1516728 (UMLS CUI [5,2])
Proton Pump Inhibitors | H2 Antagonists | Antacids
Item
treatment with proton pump inhibitors, h2 antagonists, or antacids
boolean
C0358591 (UMLS CUI [1])
C0019593 (UMLS CUI [2])
C0003138 (UMLS CUI [3])
Achlorhydria | Achlorhydria Suspected Due to Comorbidity | Anemia, Pernicious | Gastritis, Atrophic | Operation on stomach
Item
achlorhydria, either documented or suspected on the basis of an associated disease (e.g., pernicious anemia, atrophic gastritis, or certain gastric surgical procedures)
boolean
C0001075 (UMLS CUI [1])
C0001075 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0009488 (UMLS CUI [2,4])
C0002892 (UMLS CUI [3])
C0017154 (UMLS CUI [4])
C0192398 (UMLS CUI [5])
Decreased cardiac function | Heart Diseases Clinical Significance
Item
impaired cardiac function or clinically significant cardiac diseases, including any of the following:
boolean
C0232166 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Myocardial Infarction | Angina Pectoris
Item
acute myocardial infarction or angina pectoris ≤ 6 months prior to starting study drug
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification
Item
new york heart association class iii or iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
QTcF Prolongation ECG
Item
qtcf > 470 msec on the screening ecg
boolean
C3828431 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Cardiac Arrhythmia Uncontrolled | ATRIAL FIBRILLATION VENTRICULAR RATE CONTROLLED allowed
Item
uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded)
boolean
C0003811 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0741286 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Cardiovascular Disease Medical History | Uncontrolled hypertension | Labile hypertension | Antihypertensive therapy Poor compliance
Item
a past medical history of other clinically significant cardiovascular disease (e.g., uncontrolled hypertension, history of labile hypertension or history of poor compliance with an antihypertensive regimen)
boolean
C0007222 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C3665418 (UMLS CUI [3])
C0585941 (UMLS CUI [4,1])
C0032646 (UMLS CUI [4,2])
Comorbidity Severe compromises Study Subject Participation Status | Comorbidity Uncontrolled compromises Study Subject Participation Status | Lung diseases | Nervous system disorder | Communicable Disease | Communicable Disease Uncontrolled
Item
any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0024115 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0009450 (UMLS CUI [5])
C0009450 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
Cancer treatment Systemic | Therapeutic radiology procedure Systemic | Status pre- CPI-1205 Dose
Item
systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of cpi 1205
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C4053654 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
Radioimmunotherapy | iodine-131-tositumomab | yttrium-90-ibritumomab tiuxetan | Status pre- CPI-1205 Dose
Item
radioimmunotherapy (e.g., 131i-tositumomab, 90y-ibritumomab tiuxetan) less than 6 weeks before the first dose of cpi-1205
boolean
C0085101 (UMLS CUI [1])
C0768182 (UMLS CUI [2])
C1134535 (UMLS CUI [3])
C0332152 (UMLS CUI [4,1])
C4053654 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
Small Molecule Investigational | Status pre- CPI-1205 Dose
Item
treatment with an investigational small molecule less than 2 weeks before the first dose of cpi-1205.
boolean
C1328819 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C4053654 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
Antibody therapy | Status pre- CPI-1205 Dose
Item
treatment with a therapeutic antibody less than 4 weeks before the first dose of cpi-1205.
boolean
C0281176 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C4053654 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
CYP3A4 Inhibitor
Item
treatment with medications that are strong inhibitors of cyp3a4
boolean
C3830624 (UMLS CUI [1])
CYP3A4 Inducer
Item
treatment with medications that are inducers of cyp3a4 enzymes
boolean
C3830625 (UMLS CUI [1])
Pharmaceutical Preparations At risk Torsades de Pointes
Item
treatment with medications that are known to carry a risk of torsades de pointes
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Females & males of reproductive potential Contraceptive methods Unwilling
Item
women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
patients unwilling or unable to comply with this study protocol
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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