ID

14020

Beskrivning

A Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01961882

Länk

https://clinicaltrials.gov/show/NCT01961882

Nyckelord

  1. 2016-03-22 2016-03-22 -
Uppladdad den

22 mars 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Acute Myeloid Leukemia NCT01961882

Eligibility Acute Myeloid Leukemia NCT01961882

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patients with aml who achieved first complete remission within one or two courses of standard induction therapy, and completed standard consolidation therapy (more than one course).
Beskrivning

Acute myeloid leukemia in remission

Datatyp

boolean

Alias
UMLS CUI [1]
C0153886
Patients who are 60 years or older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0153886
Patients who have provided written informed consent within 90 days from the last dose of consolidation therapy on an informed consent form that has been approved by an institutional review board or independent ethics committee.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
Patients who have acute promyelocytic leukemia (apl) with t(15;17) (q22;q12), (pml/rara) karyotype abnormalities, and other variant types.
Beskrivning

Acute Promyelocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0023487
Patients who are scheduled for hematopoietic stem cell transplantation
Beskrivning

Peripheral Stem Cell Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0242602
Patients who have received drugs potentially affecting the immune system within 4 weeks before starting imp administration or who may receive such drugs after start of the trial.
Beskrivning

Drugs potentially affecting the immune system

Datatyp

boolean

Alias
UMLS CUI [1]
C1532237
Patients who have a severe concurrent disease or psychiatric illness likely to interfere with participation in this trial.
Beskrivning

Concurrent disease or psychiatric illness

Datatyp

boolean

Alias
UMLS CUI [1]
C0205420
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0525058
Patients who are hiv antibody positive, hbv-dna positive or have unrecovered chronic hepatitis c with positive hcv antibody.
Beskrivning

HIV positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C1168040
Patients who have cirrhosis.
Beskrivning

cirrhosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0023890
Patients judged to be ineligible by the investigator (or subinvestigator) for any other reasons.
Beskrivning

Ineligibility

Datatyp

boolean

Alias
UMLS CUI [1]
C1512714

Similar models

Eligibility Acute Myeloid Leukemia NCT01961882

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Acute myeloid leukemia in remission
Item
Patients with aml who achieved first complete remission within one or two courses of standard induction therapy, and completed standard consolidation therapy (more than one course).
boolean
C0153886 (UMLS CUI [1])
Age
Item
Patients who are 60 years or older.
boolean
C0153886 (UMLS CUI [1])
Informed Consent
Item
Patients who have provided written informed consent within 90 days from the last dose of consolidation therapy on an informed consent form that has been approved by an institutional review board or independent ethics committee.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Promyelocytic Leukemia
Item
Patients who have acute promyelocytic leukemia (apl) with t(15;17) (q22;q12), (pml/rara) karyotype abnormalities, and other variant types.
boolean
C0023487 (UMLS CUI [1])
Peripheral Stem Cell Transplantation
Item
Patients who are scheduled for hematopoietic stem cell transplantation
boolean
C0242602 (UMLS CUI [1])
Drugs potentially affecting the immune system
Item
Patients who have received drugs potentially affecting the immune system within 4 weeks before starting imp administration or who may receive such drugs after start of the trial.
boolean
C1532237 (UMLS CUI [1])
Concurrent disease or psychiatric illness
Item
Patients who have a severe concurrent disease or psychiatric illness likely to interfere with participation in this trial.
boolean
C0205420 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0525058 (UMLS CUI [3])
HIV positive
Item
Patients who are hiv antibody positive, hbv-dna positive or have unrecovered chronic hepatitis c with positive hcv antibody.
boolean
C0019699 (UMLS CUI [1])
C1168040 (UMLS CUI [2])
cirrhosis
Item
Patients who have cirrhosis.
boolean
C0023890 (UMLS CUI [1])
Ineligibility
Item
Patients judged to be ineligible by the investigator (or subinvestigator) for any other reasons.
boolean
C1512714 (UMLS CUI [1])

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