ID

21385

Beschreibung

Therapy of Chronic Lymphocytic Leukemia With Dasatinib (BMS-354825); ODM derived from: https://clinicaltrials.gov/show/NCT00364286

Link

https://clinicaltrials.gov/show/NCT00364286

Stichworte

Versionen (1)
  1. 18.04.17 18.04.17 -
Hochgeladen am

18. April 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Leukemia NCT00364286

Englisch

Eligibility Leukemia NCT00364286

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00364286
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of cll, small lymphocytic lymphoma (sll), or -cell prolymphocytic leukemia (t-pll).
Beschreibung

Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | T-Cell Prolymphocytic Leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C0855095
UMLS CUI [3]
C2363142
2. previously treated with chemotherapy or monoclonal antibodies.
Beschreibung

Chemotherapy | Monoclonal Antibody Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279694
3. all patients with rai stage iii-iv are eligible. - or - patients with rai stage 0-ii who meet one or more indication for treatment as defined by the nci-sponsored working group are eligible:massive or progressive splenomegaly; massive lymph nodes, nodal clusters, or progressive lymphadenopathy; grade 2 or 3 fatigue, fever >/= 100.5 degrees f, night sweats for > 2 weeks w/o documented infection, presence of weight loss >/= 10% over the preceding 6 months; progressive lymphocytosis with increase in lymphocyte count of >/= 50% over a 2-month period or an anticipated doubling time of < 6 months.
Beschreibung

Rai Staging System | Indication Quantity Therapeutic procedure | splenomegaly massive | Splenomegaly Progressive | Lymph nodes Massive | Lymph nodes Cluster | Lymphadenopathy Progressive | Fatigue Grade | Fever Degrees fahrenheit | Night sweats Without Infection | Weight decreased | Lymphocytosis Progressive | Lymphocyte count increased | Lymphocyte Doubling Time

Datentyp

boolean

Alias
UMLS CUI [1]
C1514715
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0087111
UMLS CUI [3]
C0241231
UMLS CUI [4,1]
C0038002
UMLS CUI [4,2]
C0205329
UMLS CUI [5,1]
C0024204
UMLS CUI [5,2]
C0522501
UMLS CUI [6,1]
C0024204
UMLS CUI [6,2]
C1704332
UMLS CUI [7,1]
C0497156
UMLS CUI [7,2]
C0205329
UMLS CUI [8,1]
C0015672
UMLS CUI [8,2]
C0441800
UMLS CUI [9,1]
C0015967
UMLS CUI [9,2]
C0456628
UMLS CUI [10,1]
C0028081
UMLS CUI [10,2]
C0332288
UMLS CUI [10,3]
C3714514
UMLS CUI [11]
C1262477
UMLS CUI [12,1]
C0024282
UMLS CUI [12,2]
C0205329
UMLS CUI [13]
C0853698
UMLS CUI [14,1]
C0024264
UMLS CUI [14,2]
C2986483
4. serum bilirubin less than 2mg/dl, serum creatinine less than 2mg/dl unless abnormality is considered due to cll by investigator.
Beschreibung

Serum total bilirubin measurement | Creatinine measurement, serum | Abnormality Due to Chronic Lymphocytic Leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0023434
5. the eastern cooperative oncology group (ecog) performance status < 3.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
6. patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Beschreibung

Informed Consent | Compliance behavior

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
7. sexually active women of childbearing potential must use birth control during study in manner that risk of failure is minimized. prior to study enrollment women of childbearing potential must be advised of importance of avoiding pregnancy during trial and potential risk factors for unintentional pregnancy. must have negative pregnancy test. if pregnancy test is positive patient must not receive investigational product and must not be enrolled in study. men enrolled on study should understand risks to sexual partner of childbearing potential and practice effective birth control.
Beschreibung

Sexually active Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative | Pregnancy test positive Prevention Investigational New Drugs | Pregnancy test positive Study Subject Participation Status Exclusion | Gender Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0241028
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
UMLS CUI [3,1]
C0240802
UMLS CUI [3,2]
C2700409
UMLS CUI [3,3]
C0013230
UMLS CUI [4,1]
C0240802
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C2828389
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0700589
8. inclusion of women and minorities: as per nih policy, women and members of minorities will be included in this protocol as they are referred in the relevant populations. there are no exclusions of women or minorities based on the study objectives.
Beschreibung

Gender | Minorities

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0026192
9. new york heart association (nyha) class < 3
Beschreibung

New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C1275491
10. patients must sign informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or breast-feeding women are excluded.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. patients may not receive concurrent chemotherapy, radiotherapy, or immunotherapy. localized radiotherapy to an area not compromising bone marrow function does not apply, nor do hematopoietic growth factors such as erythropoietin, g-csf, gm-csf etc.
Beschreibung

Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Therapeutic radiology procedure Localized | Bone Marrow function Intact | Hematopoietic Growth Factors | Erythropoietin | Granulocyte Colony-Stimulating Factor | Granulocyte-Macrophage Colony-Stimulating Factor

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0392752
UMLS CUI [5,1]
C0005953
UMLS CUI [5,2]
C0031843
UMLS CUI [5,3]
C0205266
UMLS CUI [6]
C0079490
UMLS CUI [7]
C0014822
UMLS CUI [8]
C0079459
UMLS CUI [9]
C0079460
3. patients must not have untreated or uncontrolled life-threatening infection.
Beschreibung

Life-threatening infection Untreated | Life-threatening infection Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1859430
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1859430
UMLS CUI [2,2]
C0205318
4. uncontrolled angina within 3 months; diagnosed or suspected congenital long qt syndrome; any history of clinically significant ventricular arrhythmias; prolonged qtc interval (> 450 msec); uncontrolled hypertension; significant bleeding disorder unrelated to cancer; patients currently taking drugs that are generally accepted to have a risk of causing torsades de pointes.
Beschreibung

Angina Pectoris Uncontrolled | Congenital long QT syndrome | Congenital long QT syndrome Suspected | Ventricular arrhythmia | Prolonged QTc interval | Uncontrolled hypertension | Blood Coagulation Disorder Without Malignant Neoplasm | Pharmaceutical Preparations Causing Torsades de Pointes

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C1141890
UMLS CUI [3,1]
C1141890
UMLS CUI [3,2]
C0750491
UMLS CUI [4]
C0085612
UMLS CUI [5]
C1560305
UMLS CUI [6]
C1868885
UMLS CUI [7,1]
C0005779
UMLS CUI [7,2]
C0332288
UMLS CUI [7,3]
C0006826
UMLS CUI [8,1]
C0013227
UMLS CUI [8,2]
C0678227
UMLS CUI [8,3]
C0040479
5. medications that inhibit platelet function (i.e., aspirin, dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and any non-steroidal anti-inflammatory drug) or anticoagulants (warfarin, heparin/low molecular weight heparin [e.g., danaparoid, dalteparin, tinzaparin, enoxaparin]).
Beschreibung

Pharmaceutical Preparations Inhibiting Platelet function | Aspirin | Dipyridamole | Epoprostenol | eptifibatide | clopidogrel | cilostazol | abciximab | Ticlopidine | Anti-Inflammatory Agents, Non-Steroidal | Anticoagulants | Warfarin | Heparin | Heparin, Low-Molecular-Weight | danaparoid | Dalteparin | tinzaparin | Enoxaparin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3463820
UMLS CUI [1,3]
C1254881
UMLS CUI [2]
C0004057
UMLS CUI [3]
C0012582
UMLS CUI [4]
C0033567
UMLS CUI [5]
C0253563
UMLS CUI [6]
C0070166
UMLS CUI [7]
C0055729
UMLS CUI [8]
C0288672
UMLS CUI [9]
C0040207
UMLS CUI [10]
C0003211
UMLS CUI [11]
C0003280
UMLS CUI [12]
C0043031
UMLS CUI [13]
C0019134
UMLS CUI [14]
C0019139
UMLS CUI [15]
C0259507
UMLS CUI [16]
C0206461
UMLS CUI [17]
C0216278
UMLS CUI [18]
C0206460
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Leukemia NCT00364286

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00364286
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | T-Cell Prolymphocytic Leukemia
Item
1. diagnosis of cll, small lymphocytic lymphoma (sll), or -cell prolymphocytic leukemia (t-pll).
boolean
C0023434 (UMLS CUI [1])
C0855095 (UMLS CUI [2])
C2363142 (UMLS CUI [3])
Chemotherapy | Monoclonal Antibody Therapy
Item
2. previously treated with chemotherapy or monoclonal antibodies.
boolean
C0392920 (UMLS CUI [1])
C0279694 (UMLS CUI [2])
Rai Staging System | Indication Quantity Therapeutic procedure | splenomegaly massive | Splenomegaly Progressive | Lymph nodes Massive | Lymph nodes Cluster | Lymphadenopathy Progressive | Fatigue Grade | Fever Degrees fahrenheit | Night sweats Without Infection | Weight decreased | Lymphocytosis Progressive | Lymphocyte count increased | Lymphocyte Doubling Time
Item
3. all patients with rai stage iii-iv are eligible. - or - patients with rai stage 0-ii who meet one or more indication for treatment as defined by the nci-sponsored working group are eligible:massive or progressive splenomegaly; massive lymph nodes, nodal clusters, or progressive lymphadenopathy; grade 2 or 3 fatigue, fever >/= 100.5 degrees f, night sweats for > 2 weeks w/o documented infection, presence of weight loss >/= 10% over the preceding 6 months; progressive lymphocytosis with increase in lymphocyte count of >/= 50% over a 2-month period or an anticipated doubling time of < 6 months.
boolean
C1514715 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0241231 (UMLS CUI [3])
C0038002 (UMLS CUI [4,1])
C0205329 (UMLS CUI [4,2])
C0024204 (UMLS CUI [5,1])
C0522501 (UMLS CUI [5,2])
C0024204 (UMLS CUI [6,1])
C1704332 (UMLS CUI [6,2])
C0497156 (UMLS CUI [7,1])
C0205329 (UMLS CUI [7,2])
C0015672 (UMLS CUI [8,1])
C0441800 (UMLS CUI [8,2])
C0015967 (UMLS CUI [9,1])
C0456628 (UMLS CUI [9,2])
C0028081 (UMLS CUI [10,1])
C0332288 (UMLS CUI [10,2])
C3714514 (UMLS CUI [10,3])
C1262477 (UMLS CUI [11])
C0024282 (UMLS CUI [12,1])
C0205329 (UMLS CUI [12,2])
C0853698 (UMLS CUI [13])
C0024264 (UMLS CUI [14,1])
C2986483 (UMLS CUI [14,2])
Serum total bilirubin measurement | Creatinine measurement, serum | Abnormality Due to Chronic Lymphocytic Leukemia
Item
4. serum bilirubin less than 2mg/dl, serum creatinine less than 2mg/dl unless abnormality is considered due to cll by investigator.
boolean
C1278039 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0023434 (UMLS CUI [3,3])
ECOG performance status
Item
5. the eastern cooperative oncology group (ecog) performance status < 3.
boolean
C1520224 (UMLS CUI [1])
Informed Consent | Compliance behavior
Item
6. patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
Sexually active Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative | Pregnancy test positive Prevention Investigational New Drugs | Pregnancy test positive Study Subject Participation Status Exclusion | Gender Contraceptive methods
Item
7. sexually active women of childbearing potential must use birth control during study in manner that risk of failure is minimized. prior to study enrollment women of childbearing potential must be advised of importance of avoiding pregnancy during trial and potential risk factors for unintentional pregnancy. must have negative pregnancy test. if pregnancy test is positive patient must not receive investigational product and must not be enrolled in study. men enrolled on study should understand risks to sexual partner of childbearing potential and practice effective birth control.
boolean
C0241028 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C0240802 (UMLS CUI [3,1])
C2700409 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C0240802 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C2828389 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Gender | Minorities
Item
8. inclusion of women and minorities: as per nih policy, women and members of minorities will be included in this protocol as they are referred in the relevant populations. there are no exclusions of women or minorities based on the study objectives.
boolean
C0079399 (UMLS CUI [1])
C0026192 (UMLS CUI [2])
New York Heart Association Classification
Item
9. new york heart association (nyha) class < 3
boolean
C1275491 (UMLS CUI [1])
Informed Consent
Item
10. patients must sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant or breast-feeding women are excluded.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Therapeutic radiology procedure Localized | Bone Marrow function Intact | Hematopoietic Growth Factors | Erythropoietin | Granulocyte Colony-Stimulating Factor | Granulocyte-Macrophage Colony-Stimulating Factor
Item
2. patients may not receive concurrent chemotherapy, radiotherapy, or immunotherapy. localized radiotherapy to an area not compromising bone marrow function does not apply, nor do hematopoietic growth factors such as erythropoietin, g-csf, gm-csf etc.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1522449 (UMLS CUI [4,1])
C0392752 (UMLS CUI [4,2])
C0005953 (UMLS CUI [5,1])
C0031843 (UMLS CUI [5,2])
C0205266 (UMLS CUI [5,3])
C0079490 (UMLS CUI [6])
C0014822 (UMLS CUI [7])
C0079459 (UMLS CUI [8])
C0079460 (UMLS CUI [9])
Life-threatening infection Untreated | Life-threatening infection Uncontrolled
Item
3. patients must not have untreated or uncontrolled life-threatening infection.
boolean
C1859430 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1859430 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Angina Pectoris Uncontrolled | Congenital long QT syndrome | Congenital long QT syndrome Suspected | Ventricular arrhythmia | Prolonged QTc interval | Uncontrolled hypertension | Blood Coagulation Disorder Without Malignant Neoplasm | Pharmaceutical Preparations Causing Torsades de Pointes
Item
4. uncontrolled angina within 3 months; diagnosed or suspected congenital long qt syndrome; any history of clinically significant ventricular arrhythmias; prolonged qtc interval (> 450 msec); uncontrolled hypertension; significant bleeding disorder unrelated to cancer; patients currently taking drugs that are generally accepted to have a risk of causing torsades de pointes.
boolean
C0002962 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1141890 (UMLS CUI [2])
C1141890 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0085612 (UMLS CUI [4])
C1560305 (UMLS CUI [5])
C1868885 (UMLS CUI [6])
C0005779 (UMLS CUI [7,1])
C0332288 (UMLS CUI [7,2])
C0006826 (UMLS CUI [7,3])
C0013227 (UMLS CUI [8,1])
C0678227 (UMLS CUI [8,2])
C0040479 (UMLS CUI [8,3])
Pharmaceutical Preparations Inhibiting Platelet function | Aspirin | Dipyridamole | Epoprostenol | eptifibatide | clopidogrel | cilostazol | abciximab | Ticlopidine | Anti-Inflammatory Agents, Non-Steroidal | Anticoagulants | Warfarin | Heparin | Heparin, Low-Molecular-Weight | danaparoid | Dalteparin | tinzaparin | Enoxaparin
Item
5. medications that inhibit platelet function (i.e., aspirin, dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and any non-steroidal anti-inflammatory drug) or anticoagulants (warfarin, heparin/low molecular weight heparin [e.g., danaparoid, dalteparin, tinzaparin, enoxaparin]).
boolean
C0013227 (UMLS CUI [1,1])
C3463820 (UMLS CUI [1,2])
C1254881 (UMLS CUI [1,3])
C0004057 (UMLS CUI [2])
C0012582 (UMLS CUI [3])
C0033567 (UMLS CUI [4])
C0253563 (UMLS CUI [5])
C0070166 (UMLS CUI [6])
C0055729 (UMLS CUI [7])
C0288672 (UMLS CUI [8])
C0040207 (UMLS CUI [9])
C0003211 (UMLS CUI [10])
C0003280 (UMLS CUI [11])
C0043031 (UMLS CUI [12])
C0019134 (UMLS CUI [13])
C0019139 (UMLS CUI [14])
C0259507 (UMLS CUI [15])
C0206461 (UMLS CUI [16])
C0216278 (UMLS CUI [17])
C0206460 (UMLS CUI [18])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video