ID

12940

Descripción

Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase; ODM derived from: https://clinicaltrials.gov/show/NCT00003694

Link

https://clinicaltrials.gov/show/NCT00003694

Palabras clave

Versiones (1)
  1. 7/1/16 7/1/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

7 de enero de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Chronic Myelogenous Leukemia, BCR-ABL1 Positive NCT00003694

Inglés

Eligibility Chronic Myelogenous Leukemia, BCR-ABL1 Positive NCT00003694

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic diagnosis of chronic myelogenous leukemia (cml) in chronic phase; patients in either accelerated or blastic phases are not eligible; clonal cytogenetic evolution alone does not exclude patients
Descripción

chronic myelogenous leukemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023473
patients must meet one or more of the following criteria:
Descripción

inclusion criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1512693
cytogenetically determined philadelphia chromosome (ph+)
Descripción

philadelphia chromosome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031526
bcr/abl protein detectable by immunoblotting
Descripción

bcr/abl protein

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004891
polymerase chain reaction (pcr) positive fusion transcripts for bcr/abl
Descripción

fusion transcripts for bcr/abl

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004891
UMLS CUI [2]
C0032520
bcr/abl translocation present by fluorescence in situ hybridization (fish)
Descripción

bcr/abl translocation present by fluorescence in situ hybridization (fish)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004891
UMLS CUI [2]
C0162789
registration within eight weeks of the diagnosis and confirmation of ph+ or bcr/abl+
Descripción

registration within eight weeks of the diagnosis and confirmation of ph+ or bcr/abl+

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031526
UMLS CUI [2]
C0004891
no more than eight weeks of prior hydroxyurea therapy
Descripción

hydroxyurea

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020402
no previous therapy with homoharringtonine (hht)
Descripción

homoharringtonine

Tipo de datos

boolean

no prior treatment for cml with agents other than hydroxyurea; thus, prior treatment for cml with agents such as interferon, busulfan or cytarabine will render patients ineligible
Descripción

no prior treatment for cml with agents other than hydroxyurea; thus, prior treatment for cml with agents such as interferon, busulfan or cytarabine will render patients ineligible

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0733470
UMLS CUI [2]
C0006463
UMLS CUI [3]
C0010711
must not be a candidate for an early allogeneic bone marrow transplant; potential transplant candidates must be counseled about alternative donor transplants and must decline that treatment option
Descripción

allogeneic bone marrow transplant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005961
ecog performance status 0-2
Descripción

ecog performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control
Descripción

non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
bilirubin =< x upper limit of normal
Descripción

bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
creatinine =< 1.5 mg/dl
Descripción

creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
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Similar models

Eligibility Chronic Myelogenous Leukemia, BCR-ABL1 Positive NCT00003694

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
chronic myelogenous leukemia
Item
histologic diagnosis of chronic myelogenous leukemia (cml) in chronic phase; patients in either accelerated or blastic phases are not eligible; clonal cytogenetic evolution alone does not exclude patients
boolean
C0023473 (UMLS CUI [1])
inclusion criteria
Item
patients must meet one or more of the following criteria:
boolean
C1512693 (UMLS CUI [1])
philadelphia chromosome
Item
cytogenetically determined philadelphia chromosome (ph+)
boolean
C0031526 (UMLS CUI [1])
bcr/abl protein
Item
bcr/abl protein detectable by immunoblotting
boolean
C0004891 (UMLS CUI [1])
fusion transcripts for bcr/abl
Item
polymerase chain reaction (pcr) positive fusion transcripts for bcr/abl
boolean
C0004891 (UMLS CUI [1])
C0032520 (UMLS CUI [2])
bcr/abl translocation present by fluorescence in situ hybridization (fish)
Item
bcr/abl translocation present by fluorescence in situ hybridization (fish)
boolean
C0004891 (UMLS CUI [1])
C0162789 (UMLS CUI [2])
registration within eight weeks of the diagnosis and confirmation of ph+ or bcr/abl+
Item
registration within eight weeks of the diagnosis and confirmation of ph+ or bcr/abl+
boolean
C0031526 (UMLS CUI [1])
C0004891 (UMLS CUI [2])
hydroxyurea
Item
no more than eight weeks of prior hydroxyurea therapy
boolean
C0020402 (UMLS CUI [1])
homoharringtonine
Item
no previous therapy with homoharringtonine (hht)
boolean
no prior treatment for cml with agents other than hydroxyurea; thus, prior treatment for cml with agents such as interferon, busulfan or cytarabine will render patients ineligible
Item
no prior treatment for cml with agents other than hydroxyurea; thus, prior treatment for cml with agents such as interferon, busulfan or cytarabine will render patients ineligible
boolean
C0733470 (UMLS CUI [1])
C0006463 (UMLS CUI [2])
C0010711 (UMLS CUI [3])
allogeneic bone marrow transplant
Item
must not be a candidate for an early allogeneic bone marrow transplant; potential transplant candidates must be counseled about alternative donor transplants and must decline that treatment option
boolean
C0005961 (UMLS CUI [1])
ecog performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control
Item
non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
bilirubin
Item
bilirubin =< x upper limit of normal
boolean
C1278039 (UMLS CUI [1])
creatinine
Item
creatinine =< 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
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