ID

13169

Beschrijving

A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies; ODM derived from: https://clinicaltrials.gov/show/NCT00719836

Link

https://clinicaltrials.gov/show/NCT00719836

Trefwoorden

Versies (1)
  1. 21-01-16 21-01-16 -
Houder van rechten

CC BY-NC 3.0

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21 januari 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT00719836

Engels

Eligibility Acute Myelogenous Leukemia NCT00719836

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
during the dose escalation phase: subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies. this includes the following:
Beschrijving

subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies

Datatype

boolean

subjects with acute myelogenous leukemia (aml)
Beschrijving

AML

Datatype

boolean

Alias
UMLS CUI [1]
C0023467
subjects with chronic myelogenous leukemia (cml) in accelerated phase
Beschrijving

CML in accelerated phase

Datatype

boolean

Alias
UMLS CUI [1]
C0023473
subjects with chronic myelogenous leukemia (cml) in blast crisis
Beschrijving

CML in blast crisis

Datatype

boolean

Alias
UMLS CUI [1]
C0023473
subjects with high-risk myelodysplastic syndromes (mds) or chronic myelomonocytic leukemia (cmml)
Beschrijving

MDS or CMML

Datatype

boolean

Alias
UMLS CUI [1]
C3463824
UMLS CUI [2]
C0023480
subjects with advanced myelofibrosis (mf)
Beschrijving

Myelofibrosis

Datatype

boolean

Alias
UMLS CUI [1]
C0001815
in phase 2, subjects with cimf (as well as post et/pv mf)
Beschrijving

cimf

Datatype

boolean

Alias
UMLS CUI [1]
C0001815
eastern cooperative oncology group (ecog) performance status 0-2
Beschrijving

ECOG status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
all men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists. additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug
Beschrijving

pregnancy and contraception

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
able to understand and willing to sign the informed consent form
Beschrijving

informed consent form

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with chronic myelogenous leukemia (cml) in chronic phase;
Beschrijving

CML in chronic phase

Datatype

boolean

Alias
UMLS CUI [1]
C0023474
uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. subjects receiving antibiotics for infections that are under control may be included in the study;
Beschrijving

illnesses that would limit compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study;
Beschrijving

malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
known hiv-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy);
Beschrijving

HIV

Datatype

boolean

Alias
UMLS CUI [1]
C0019682
known active hepatitis a, b, or c;
Beschrijving

hepatitis a, b, or c

Datatype

boolean

Alias
UMLS CUI [1]
C0019158
women who are pregnant or lactating.
Beschrijving

pregnancy or lactation

Datatype

boolean

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

Eligibility Acute Myelogenous Leukemia NCT00719836

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies
Item
during the dose escalation phase: subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies. this includes the following:
boolean
AML
Item
subjects with acute myelogenous leukemia (aml)
boolean
C0023467 (UMLS CUI [1])
CML in accelerated phase
Item
subjects with chronic myelogenous leukemia (cml) in accelerated phase
boolean
C0023473 (UMLS CUI [1])
CML in blast crisis
Item
subjects with chronic myelogenous leukemia (cml) in blast crisis
boolean
C0023473 (UMLS CUI [1])
MDS or CMML
Item
subjects with high-risk myelodysplastic syndromes (mds) or chronic myelomonocytic leukemia (cmml)
boolean
C3463824 (UMLS CUI [1])
C0023480 (UMLS CUI [2])
Myelofibrosis
Item
subjects with advanced myelofibrosis (mf)
boolean
C0001815 (UMLS CUI [1])
cimf
Item
in phase 2, subjects with cimf (as well as post et/pv mf)
boolean
C0001815 (UMLS CUI [1])
ECOG status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
pregnancy and contraception
Item
all men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists. additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
informed consent form
Item
able to understand and willing to sign the informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CML in chronic phase
Item
subjects with chronic myelogenous leukemia (cml) in chronic phase;
boolean
C0023474 (UMLS CUI [1])
illnesses that would limit compliance
Item
uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. subjects receiving antibiotics for infections that are under control may be included in the study;
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
malignancy
Item
concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study;
boolean
C0006826 (UMLS CUI [1])
HIV
Item
known hiv-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy);
boolean
C0019682 (UMLS CUI [1])
hepatitis a, b, or c
Item
known active hepatitis a, b, or c;
boolean
C0019158 (UMLS CUI [1])
pregnancy or lactation
Item
women who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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