ID

16694

Beschreibung

Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00101647

Link

https://clinicaltrials.gov/show/NCT00101647

Stichworte

Versionen (1)
  1. 01.08.16 01.08.16 -
Hochgeladen am

1. August 2016

DOI

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Eligibility Chronic Myelogenous Leukemia NCT00101647

Englisch

Eligibility Chronic Myelogenous Leukemia NCT00101647

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with philadelphia chromosome positive (ph+) or the fused gene bcr/abl positive (bcr/abl+) accelerated phase chronic myeloid leukemia (cml) whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
Beschreibung

Philadelphia chromosome positive chronic myelogenous leukemia | Chronic myeloid leukemia, BCR/ABL-positive | Leukemia, Myeloid, Accelerated Phase | Resistance Hematologic Primary Imatinib mesylate | Resistance Hematologic Acquired Imatinib mesylate | intolerance to Imatinib mesylate

Datentyp

boolean

Alias
UMLS CUI [1]
C0279543
UMLS CUI [2]
C2861580
UMLS CUI [3]
C0023472
UMLS CUI [4,1]
C1514892
UMLS CUI [4,2]
C0205488
UMLS CUI [4,3]
C0205225
UMLS CUI [4,4]
C0939537
UMLS CUI [5,1]
C1514892
UMLS CUI [5,2]
C0205488
UMLS CUI [5,3]
C0439661
UMLS CUI [5,4]
C0939537
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0939537
subjects must have had prior exposure to imatinib. however, imatinib mesylate does not need to be their most recent cml treatment prior to coming on this study.
Beschreibung

imatinib; Exposure to | Imatinib mesylate | Therapeutic procedure Chronic Myeloid Leukemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935989
UMLS CUI [1,2]
C0332157
UMLS CUI [2]
C0939537
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0023473
men and women, 18 years of age or older.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
adequate hepatic function.
Beschreibung

Liver function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
adequate renal function.
Beschreibung

Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.
Beschreibung

Childbearing Potential Contraceptive methods | Low risk pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0404841
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breastfeeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects who are eligible and willing to undergo transplantation during the screening period.
Beschreibung

Transplantation Suitable Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0600109
a serious uncontrolled medical disorder or active infection that would impair the ability of the subjects to receive protocol therapy.
Beschreibung

Disease Uncontrolled Serious Impairing Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0205404
UMLS CUI [1,4]
C0221099
UMLS CUI [1,5]
C0525058
uncontrolled or significant cardiovascular disease.
Beschreibung

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0750502
medications that increase bleeding risk.
Beschreibung

Pharmaceutical Preparations Bleeding Risk Increase

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3251812
UMLS CUI [1,3]
C0442805
medications that change heart rhythms.
Beschreibung

Pharmaceutical Preparations Changing Cardiac rhythms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0232187
dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
Beschreibung

Dementia Preventing Informed Consent | Abnormal mental state Preventing Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0278061
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
history of significant bleeding disorder unrelated to cml.
Beschreibung

Blood Coagulation Disorders Significant Independent of Chronic Myeloid Leukemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0332291
UMLS CUI [1,4]
C0023473
concurrent incurable malignancy other than cml.
Beschreibung

Malignant Neoplasm incurable | Myeloid Leukemia, Chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0175969
UMLS CUI [2]
C0023473
evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.
Beschreibung

organ dysfunction Evidence Preventing Protocol Compliance | Digestive organ Dysfunction Preventing Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0349410
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C0227435
UMLS CUI [2,2]
C3887504
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0525058
prior therapy with dasatinib (bms-354825).
Beschreibung

dasatinib | BMS 354825

Datentyp

boolean

Alias
UMLS CUI [1]
C1455147
UMLS CUI [2]
C1328005
prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Beschreibung

Prisoners | In prison Involuntary Therapeutic procedure Mental disorders | In prison Involuntary Therapeutic procedure physical illness | In prison Involuntary Therapeutic procedure Communicable Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0033167
UMLS CUI [2,1]
C0392751
UMLS CUI [2,2]
C2986385
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C0004936
UMLS CUI [3,1]
C0392751
UMLS CUI [3,2]
C2986385
UMLS CUI [3,3]
C0087111
UMLS CUI [3,4]
C0683323
UMLS CUI [4,1]
C0392751
UMLS CUI [4,2]
C2986385
UMLS CUI [4,3]
C0087111
UMLS CUI [4,4]
C0009450
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Ähnliche Modelle

Eligibility Chronic Myelogenous Leukemia NCT00101647

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Philadelphia chromosome positive chronic myelogenous leukemia | Chronic myeloid leukemia, BCR/ABL-positive | Leukemia, Myeloid, Accelerated Phase | Resistance Hematologic Primary Imatinib mesylate | Resistance Hematologic Acquired Imatinib mesylate | intolerance to Imatinib mesylate
Item
subjects with philadelphia chromosome positive (ph+) or the fused gene bcr/abl positive (bcr/abl+) accelerated phase chronic myeloid leukemia (cml) whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
boolean
C0279543 (UMLS CUI [1])
C2861580 (UMLS CUI [2])
C0023472 (UMLS CUI [3])
C1514892 (UMLS CUI [4,1])
C0205488 (UMLS CUI [4,2])
C0205225 (UMLS CUI [4,3])
C0939537 (UMLS CUI [4,4])
C1514892 (UMLS CUI [5,1])
C0205488 (UMLS CUI [5,2])
C0439661 (UMLS CUI [5,3])
C0939537 (UMLS CUI [5,4])
C1744706 (UMLS CUI [6,1])
C0939537 (UMLS CUI [6,2])
imatinib; Exposure to | Imatinib mesylate | Therapeutic procedure Chronic Myeloid Leukemia
Item
subjects must have had prior exposure to imatinib. however, imatinib mesylate does not need to be their most recent cml treatment prior to coming on this study.
boolean
C0935989 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0939537 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0023473 (UMLS CUI [3,2])
Age
Item
men and women, 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Liver function
Item
adequate hepatic function.
boolean
C0232741 (UMLS CUI [1])
Renal function
Item
adequate renal function.
boolean
C0232804 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Low risk pregnancy
Item
women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0404841 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Transplantation Suitable Willing
Item
subjects who are eligible and willing to undergo transplantation during the screening period.
boolean
C0040732 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Disease Uncontrolled Serious Impairing Protocol Compliance
Item
a serious uncontrolled medical disorder or active infection that would impair the ability of the subjects to receive protocol therapy.
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0221099 (UMLS CUI [1,4])
C0525058 (UMLS CUI [1,5])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Significant
Item
uncontrolled or significant cardiovascular disease.
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Pharmaceutical Preparations Bleeding Risk Increase
Item
medications that increase bleeding risk.
boolean
C0013227 (UMLS CUI [1,1])
C3251812 (UMLS CUI [1,2])
C0442805 (UMLS CUI [1,3])
Pharmaceutical Preparations Changing Cardiac rhythms
Item
medications that change heart rhythms.
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0232187 (UMLS CUI [1,3])
Dementia Preventing Informed Consent | Abnormal mental state Preventing Informed Consent
Item
dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
boolean
C0497327 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0278061 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Blood Coagulation Disorders Significant Independent of Chronic Myeloid Leukemia
Item
history of significant bleeding disorder unrelated to cml.
boolean
C0005779 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332291 (UMLS CUI [1,3])
C0023473 (UMLS CUI [1,4])
Malignant Neoplasm incurable | Myeloid Leukemia, Chronic
Item
concurrent incurable malignancy other than cml.
boolean
C0006826 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
C0023473 (UMLS CUI [2])
organ dysfunction Evidence Preventing Protocol Compliance | Digestive organ Dysfunction Preventing Protocol Compliance
Item
evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.
boolean
C0349410 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0227435 (UMLS CUI [2,1])
C3887504 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
dasatinib | BMS 354825
Item
prior therapy with dasatinib (bms-354825).
boolean
C1455147 (UMLS CUI [1])
C1328005 (UMLS CUI [2])
Prisoners | In prison Involuntary Therapeutic procedure Mental disorders | In prison Involuntary Therapeutic procedure physical illness | In prison Involuntary Therapeutic procedure Communicable Diseases
Item
prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
boolean
C0033167 (UMLS CUI [1])
C0392751 (UMLS CUI [2,1])
C2986385 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0004936 (UMLS CUI [2,4])
C0392751 (UMLS CUI [3,1])
C2986385 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0683323 (UMLS CUI [3,4])
C0392751 (UMLS CUI [4,1])
C2986385 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0009450 (UMLS CUI [4,4])
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