Informações:
Falhas:
ID
13169
Descrição
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
Palavras-chave
Versões (1)
- 21/01/2016 21/01/2016 -
Titular dos direitos
CC BY-NC 3.0
Transferido a
21 de janeiro de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT00719836
Eligibility Acute Myelogenous Leukemia NCT00719836
- StudyEvent: Eligibility
Similar models
Eligibility Acute Myelogenous Leukemia NCT00719836
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
C0700589 (UMLS CUI [2])
informed consent form
Item
able to understand and willing to sign the informed consent form
boolean
C0021430 (UMLS CUI [1])
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])
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])
C0006147 (UMLS CUI [2])