Information:
Fel:
ID
14170
Beskrivning
Tosedostat in Combination With Cytarabine or Decitabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT01567059
Länk
https://clinicaltrials.gov/show/NCT01567059
Nyckelord
Versioner (1)
- 2016-04-02 2016-04-02 -
Uppladdad den
2 april 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome NCT01567059
Eligibility Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome NCT01567059
Similar models
Eligibility Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome NCT01567059
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Informed Consent
Item
capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
boolean
C0021430 (UMLS CUI [1])
AML or MDS
Item
all adults >= 60 years of age with untreated aml or high-risk mds (10-19% marrow blasts) including those with prior myelodysplasia (mds)/aml, therapy-related aml, aml with trilineage dysplasia (aml-tld), and aml with adverse cytogenetics; patients may be enrolled if they received prior treatment with hydroxyurea to control blood counts or demethylating agents specifically for the purpose of treating mds
boolean
C0023467 (UMLS CUI [1,1])
C3463824 (UMLS CUI [1,2])
C3463824 (UMLS CUI [1,2])
Age
Item
adults age 18 to 59 with untreated aml or high-risk mds and a transplant-related mortality (trm) score of >= 9.2; previous data suggests these people would have a 25% mortality with standard therapy, making this treatment a reasonable alternative
boolean
C0001779 (UMLS CUI [1])
ECOG
Item
eastern cooperative oncology group (ecog) performance status of 0 - 2
boolean
C1520224 (UMLS CUI [1])
Creatinine, Serum
Item
serum creatinine =< 2.0 mg/dl; if serum creatinine > 2.0 mg/dl, then the estimated glomerular filtration rate (gfr) must be > 50 ml/min/1.73 m^2 as calculated by the modification of diet in renal disease equation
boolean
C0201976 (UMLS CUI [1])
Serum bilirubin
Item
serum bilirubin
boolean
C1278039 (UMLS CUI [1])
Aspartate Aminotransferase Increased (AST, SGOT (serum glutamic oxaloacetic transaminase))
Item
aspartate transaminase (ast)/alanine transaminase (alt) =< 3.0 × uln
boolean
C1557198 (UMLS CUI [1])
Alkaline Phosphatase
Item
alkaline phosphatase =< 2.5 × uln
boolean
C0201850 (UMLS CUI [1])
Contraception Behavior
Item
male subjects, even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse
boolean
C0009862 (UMLS CUI [1])
effective methods of contraception
Item
female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
boolean
C0700589 (UMLS CUI [1])
Concurrent Chemoradiotherapy
Item
current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
boolean
C3178775 (UMLS CUI [1])
Infection
Item
active uncontrolled infection
boolean
C3714514 (UMLS CUI [1])
hiv
Item
known infection with human immunodeficiency virus (hiv)
boolean
C0019682 (UMLS CUI [1])
Protocol Compliance
Item
medical condition, serious concurrent illness, or other extenuating circumstance that, in the judgment of the principal investigator, could jeopardize patient safety or interfere with the objectives of the study
boolean
C0525058 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,2])
Angina Pectoris
Item
uncontrolled angina or myocardial infarction within 6 months; patients with recent myocardial infarction apparently due to medical causes unrelated to underlying cardiac abnormalities must have a cardiac consult, and be cleared to participate in the research by the cardiologist prior to initiation of treatment and may be enrolled at the discretion of the primary investigator (pi) and treating physician
boolean
C0002962 (UMLS CUI [1])
Congestive heart failure
Item
current or history of congestive heart failure new york heart association (nyha) class 3 or 4, unless a screening echocardiogram (echo) or multiple gate acquisition scan (muga) performed within 1 month prior to study screening results in a left ventricular ejection fraction (lvef) that is >= 45% (or institutional lower limit of normal value)
boolean
C0018802 (UMLS CUI [1])
Malignant Neoplasms
Item
diagnosed or treated for another malignancy within 1 year of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
boolean
C0006826 (UMLS CUI [1])