ID

13144

Descrizione

Homoharringtonine Compared With Hydroxyurea for Chronic Myelogenous Leukemia That Has Not Responded to Interferon Alfa; ODM derived from: https://clinicaltrials.gov/show/NCT00004933

collegamento

https://clinicaltrials.gov/show/NCT00004933

Keywords

versioni (1)
  1. 19/01/16 19/01/16 -
Caricato su

19 gennaio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Leukemia NCT00004933

Inglese

Eligibility Leukemia NCT00004933

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00004933
Criteria
Descrizione

Criteria

1.1 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. see appendix i for definitions of accelerated and blastic phases of cml.
Descrizione

chronic myelogenous leukemia

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023473
1.2 patients in whom a philadelphia chromosome [t(9;22)] is not detectable by cytogenetic studies are eligible if they meet one of the following criteria:
Descrizione

philadelphia chromosome

Tipo di dati

boolean

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

bcr/abl

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0004891
bcr/abl rearrangement detectable by southern blot analysis
Descrizione

southern blot

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005862
polymerase chain reaction (pcr) positive fusion transcripts for bcr/abl
Descrizione

pcr

Tipo di dati

boolean

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

fish

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0162789
2. prior treatment:
Descrizione

treatment

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0087111
2.1 no previous therapy with homoharringtonine (hht)
Descrizione

homoharringtonine

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0062941
2.2 no more than six months cumulative (<180 days) of prior hydroxyurea (hu) therapy. however, patients may not have received more than 60 days of hu treatment after failing interferon. patients with previous intolerance or failure to respond to hu are not eligible.
Descrizione

hydroxyurea

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0020402
2.3 patients must have failed an adequate trial (5m units/m2/day) of alpha-interferon (ifn) or ifn/ara-c to be eligible, as defined below (any one of the following):
Descrizione

alpha-interferon

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0002199
failure to achieve a complete hematologic response after 6 months of ifn therapy.
Descrizione

ifn

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0002199
failure to achieve any cytogenetic response (i.e., still 100% ph+) after 12 months of ifn therapy.
Descrizione

ifn

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0002199
intolerable adverse effects of ifn therapy after at least one month of ifn treatment. significant documented toxicity of ≥ grade 3 (using nci common toxicity criteria guidelines) due to ifn is required.
Descrizione

adverse effects

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0879626
loss of a prior hematologic remission or cytogenetic response to ifn.
Descrizione

remission, response

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0544452
UMLS CUI [2]
C1704632
a two-fold increase in wbc count when compared to wbc count when ifn therapy was initiated.
Descrizione

wbc

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023508
3. age ≥ 16 years
Descrizione

age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
4. patients with uncontrolled tachyarrhythmias (such as, atrial fibrillation, paroxysmal supraventricular tachycardia, and ventricular tachycardias not adequately controlled) are not eligible.
Descrizione

tachyarrhythmias

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0080203
5. 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.
Descrizione

pregnancy, lactation, contraception

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
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Similar models

Eligibility Leukemia NCT00004933

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00004933
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
chronic myelogenous leukemia
Item
1.1 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. see appendix i for definitions of accelerated and blastic phases of cml.
boolean
C0023473 (UMLS CUI [1])
philadelphia chromosome
Item
1.2 patients in whom a philadelphia chromosome [t(9;22)] is not detectable by cytogenetic studies are eligible if they meet one of the following criteria:
boolean
C0031526 (UMLS CUI [1])
bcr/abl
Item
bcr/abl protein detectable by immunoblotting
boolean
C0004891 (UMLS CUI [1])
southern blot
Item
bcr/abl rearrangement detectable by southern blot analysis
boolean
C0005862 (UMLS CUI [1])
pcr
Item
polymerase chain reaction (pcr) positive fusion transcripts for bcr/abl
boolean
C0032520 (UMLS CUI [1])
fish
Item
bcr/abl translocation present by fluorescence in situ hybridization (fish).
boolean
C0162789 (UMLS CUI [1])
treatment
Item
2. prior treatment:
boolean
C0087111 (UMLS CUI [1])
homoharringtonine
Item
2.1 no previous therapy with homoharringtonine (hht)
boolean
C0062941 (UMLS CUI [1])
hydroxyurea
Item
2.2 no more than six months cumulative (<180 days) of prior hydroxyurea (hu) therapy. however, patients may not have received more than 60 days of hu treatment after failing interferon. patients with previous intolerance or failure to respond to hu are not eligible.
boolean
C0020402 (UMLS CUI [1])
alpha-interferon
Item
2.3 patients must have failed an adequate trial (5m units/m2/day) of alpha-interferon (ifn) or ifn/ara-c to be eligible, as defined below (any one of the following):
boolean
C0002199 (UMLS CUI [1])
ifn
Item
failure to achieve a complete hematologic response after 6 months of ifn therapy.
boolean
C0002199 (UMLS CUI [1])
ifn
Item
failure to achieve any cytogenetic response (i.e., still 100% ph+) after 12 months of ifn therapy.
boolean
C0002199 (UMLS CUI [1])
adverse effects
Item
intolerable adverse effects of ifn therapy after at least one month of ifn treatment. significant documented toxicity of ≥ grade 3 (using nci common toxicity criteria guidelines) due to ifn is required.
boolean
C0879626 (UMLS CUI [1])
remission, response
Item
loss of a prior hematologic remission or cytogenetic response to ifn.
boolean
C0544452 (UMLS CUI [1])
C1704632 (UMLS CUI [2])
wbc
Item
a two-fold increase in wbc count when compared to wbc count when ifn therapy was initiated.
boolean
C0023508 (UMLS CUI [1])
age
Item
3. age ≥ 16 years
boolean
C0001779 (UMLS CUI [1])
tachyarrhythmias
Item
4. patients with uncontrolled tachyarrhythmias (such as, atrial fibrillation, paroxysmal supraventricular tachycardia, and ventricular tachycardias not adequately controlled) are not eligible.
boolean
C0080203 (UMLS CUI [1])
pregnancy, lactation, contraception
Item
5. 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])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
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