ID

20162

Beskrivning

TALL-104 and Gleevec in Chronic Myelogenous Leukemia Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00415909

Länk

https://clinicaltrials.gov/show/NCT00415909

Nyckelord

Versioner (3)
  1. 2017-02-08 2017-02-08 -
  2. 2017-02-08 2017-02-08 -
  3. 2017-02-08 2017-02-08 -
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8 februari 2017

DOI

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Creative Commons BY-NC 3.0 Legacy
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Eligibility Chronic Myelogenous Leukemia NCT00415909

Engelsk

Eligibility Chronic Myelogenous Leukemia NCT00415909

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with cml in chronic phase who have failed to achieve or have lost an adequate response to im. for the purpose of this trial this will be defined as a lack of any cytogenetic response after 6 months of therapy or lack of major cytogenetic response after 12 months of therapy with im. patients that have lost their major or complete cytogenetic response will also be eligible. patients who show a sustained increase in breakpoint cluster region gene (bcr)-abelson gene (abl)/abl [bcr-abl/abl] ratio of >/= 1-log confirmed in at least two consecutive polymerase chain reaction (pcr) analyses (at least one month apart from each other) will also be eligible.
Beskrivning

Leukemia, Myeloid, Chronic-Phase | Imatinib mesylate Disease Response failed | Imatinib mesylate Cytogenetic Response Lacking | Cytogenetic Response Major Lacking | Cytogenetic Complete Response Lacking | BCR-ABL Fusion Gene abl gene Ratio Increase | Polymerase chain reaction analysis Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0023474
UMLS CUI [2,1]
C0939537
UMLS CUI [2,2]
C1704632
UMLS CUI [2,3]
C0231175
UMLS CUI [3,1]
C0939537
UMLS CUI [3,2]
C4055168
UMLS CUI [3,3]
C0332268
UMLS CUI [4,1]
C4055168
UMLS CUI [4,2]
C0205164
UMLS CUI [4,3]
C0332268
UMLS CUI [5,1]
C4050364
UMLS CUI [5,2]
C0332268
UMLS CUI [6,1]
C1835417
UMLS CUI [6,2]
C0079413
UMLS CUI [6,3]
C0456603
UMLS CUI [6,4]
C0442805
UMLS CUI [7,1]
C0200931
UMLS CUI [7,2]
C1265611
2. *continued from above: patients with stable molecular response defined as 2 consecutive pcr-positive results (no more than 1/2 log improvement) will also be eligible. patients must be taking stable dose of im for at least 3 months before study enrollment, and recovered from all toxicities related to im, to grade 0-1.
Beskrivning

Molecular Response Stable | Polymerase chain reaction analysis Positive Quantity | Imatinib mesylate Dose Stable | Toxic effect Imatinib mesylate Related | Patients Recovered CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4054479
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0200931
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0939537
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0939537
UMLS CUI [4,3]
C0439849
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C0521108
UMLS CUI [5,3]
C1516728
3. patients should be in complete or partial hematological remission, including white blood count (wbc) </=20 x 10(9)/l, and platelets </= 600 x 10(9)/l.
Beskrivning

Decrease Hematologic Complete | Decrease Hematologic Partial | White Blood Cell Count procedure | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0547047
UMLS CUI [1,2]
C0205488
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0547047
UMLS CUI [2,2]
C0205488
UMLS CUI [2,3]
C0728938
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0032181
4. eastern cooperative oncology group (ecog) scale performance status of 2 or less.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
5. age greater than 18 years of age since disease is extremely rare in younger age groups.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
6. adequate liver (total bilirubin of less than 2 times and aspartate aminotransferase (ast) or alanine aminotransferase (alt) of less than 2 times upper limits of normal), and renal function (creatinine of less than 2 times upper limit of normal).
Beskrivning

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0201976
7. signed informed consent form.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
8. negative pregnancy test in women of childbearing age.
Beskrivning

Childbearing Potential Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
9. negative hepatitis b and c screening blood tests.
Beskrivning

Hepatitis B Hematologic Test Negative | Hepatitis C Hematologic Test Negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0018941
UMLS CUI [2,3]
C1513916
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. serious intercurrent medical illnesses or active infections requiring parenteral antibiotics that would interfere with the ability of the patient to carry out the treatment program.
Beskrivning

Comorbidity Serious | Communicable Diseases Requirement Antibiotics Parenteral | Protocol Compliance Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003232
UMLS CUI [2,4]
C1518896
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C0439801
2. female patients who are pregnant or breast-feeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. patients taking steroids, or those anticipated to receive steroids during the trial therapy.
Beskrivning

Steroids

Datatyp

boolean

Alias
UMLS CUI [1]
C0038317
4. prior bone marrow transplant.
Beskrivning

Bone Marrow Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0005961
5. known positivity for human immunodeficiency virus (hiv).
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Chronic Myelogenous Leukemia NCT00415909

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia, Myeloid, Chronic-Phase | Imatinib mesylate Disease Response failed | Imatinib mesylate Cytogenetic Response Lacking | Cytogenetic Response Major Lacking | Cytogenetic Complete Response Lacking | BCR-ABL Fusion Gene abl gene Ratio Increase | Polymerase chain reaction analysis Quantity
Item
1. patients with cml in chronic phase who have failed to achieve or have lost an adequate response to im. for the purpose of this trial this will be defined as a lack of any cytogenetic response after 6 months of therapy or lack of major cytogenetic response after 12 months of therapy with im. patients that have lost their major or complete cytogenetic response will also be eligible. patients who show a sustained increase in breakpoint cluster region gene (bcr)-abelson gene (abl)/abl [bcr-abl/abl] ratio of >/= 1-log confirmed in at least two consecutive polymerase chain reaction (pcr) analyses (at least one month apart from each other) will also be eligible.
boolean
C0023474 (UMLS CUI [1])
C0939537 (UMLS CUI [2,1])
C1704632 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0939537 (UMLS CUI [3,1])
C4055168 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C4055168 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
C4050364 (UMLS CUI [5,1])
C0332268 (UMLS CUI [5,2])
C1835417 (UMLS CUI [6,1])
C0079413 (UMLS CUI [6,2])
C0456603 (UMLS CUI [6,3])
C0442805 (UMLS CUI [6,4])
C0200931 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
Molecular Response Stable | Polymerase chain reaction analysis Positive Quantity | Imatinib mesylate Dose Stable | Toxic effect Imatinib mesylate Related | Patients Recovered CTCAE Grades
Item
2. *continued from above: patients with stable molecular response defined as 2 consecutive pcr-positive results (no more than 1/2 log improvement) will also be eligible. patients must be taking stable dose of im for at least 3 months before study enrollment, and recovered from all toxicities related to im, to grade 0-1.
boolean
C4054479 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0200931 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0939537 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0600688 (UMLS CUI [4,1])
C0939537 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
C0030705 (UMLS CUI [5,1])
C0521108 (UMLS CUI [5,2])
C1516728 (UMLS CUI [5,3])
Decrease Hematologic Complete | Decrease Hematologic Partial | White Blood Cell Count procedure | Platelet Count measurement
Item
3. patients should be in complete or partial hematological remission, including white blood count (wbc) </=20 x 10(9)/l, and platelets </= 600 x 10(9)/l.
boolean
C0547047 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0547047 (UMLS CUI [2,1])
C0205488 (UMLS CUI [2,2])
C0728938 (UMLS CUI [2,3])
C0023508 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
ECOG performance status
Item
4. eastern cooperative oncology group (ecog) scale performance status of 2 or less.
boolean
C1520224 (UMLS CUI [1])
Age
Item
5. age greater than 18 years of age since disease is extremely rare in younger age groups.
boolean
C0001779 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
6. adequate liver (total bilirubin of less than 2 times and aspartate aminotransferase (ast) or alanine aminotransferase (alt) of less than 2 times upper limits of normal), and renal function (creatinine of less than 2 times upper limit of normal).
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Informed Consent
Item
7. signed informed consent form.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
8. negative pregnancy test in women of childbearing age.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Hepatitis B Hematologic Test Negative | Hepatitis C Hematologic Test Negative
Item
9. negative hepatitis b and c screening blood tests.
boolean
C0019163 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0019196 (UMLS CUI [2,1])
C0018941 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Comorbidity Serious | Communicable Diseases Requirement Antibiotics Parenteral | Protocol Compliance Limited
Item
1. serious intercurrent medical illnesses or active infections requiring parenteral antibiotics that would interfere with the ability of the patient to carry out the treatment program.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003232 (UMLS CUI [2,3])
C1518896 (UMLS CUI [2,4])
C0525058 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
2. female patients who are pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Steroids
Item
3. patients taking steroids, or those anticipated to receive steroids during the trial therapy.
boolean
C0038317 (UMLS CUI [1])
Bone Marrow Transplantation
Item
4. prior bone marrow transplant.
boolean
C0005961 (UMLS CUI [1])
HIV Seropositivity
Item
5. known positivity for human immunodeficiency virus (hiv).
boolean
C0019699 (UMLS CUI [1])
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