Information:
Fel:
ID
13173
Beskrivning
Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00968071
Länk
https://clinicaltrials.gov/show/NCT00968071
Nyckelord
Versioner (1)
- 2016-01-21 2016-01-21 -
Rättsinnehavare
CC BY-NC 3.0
Uppladdad den
21 januari 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT00968071
Eligibility Acute Myelogenous Leukemia NCT00968071
- StudyEvent: Eligibility
Similar models
Eligibility Acute Myelogenous Leukemia NCT00968071
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
informed consent
Item
1. understand and voluntarily sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
age
Item
2. age >/= to 16 years at the time of signing the informed consent form.
boolean
C0001779 (UMLS CUI [1])
AML, MDS
Item
3. diagnosis of acute myeloid leukemia (aml) [other than acute promyelocytic leukemia (apl)] with refractory/relapsed disease. patients with newly diagnosed aml will be eligible if not a candidate for intensive chemotherapy. patients with high-risk intermediate-2 or high by international prognostic scoring system (ipss) or >/= to 10% blasts) mds will also be eligible. all non-hematological toxicity of previous cancer therapy should have resolved to </= grade 1 (except alopecia or other toxicities not involving major organs).
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
C3463824 (UMLS CUI [2])
ECOG performance status
Item
4. eastern cooperative oncology group (ecog) performance status of </= to 3 at study entry.
boolean
C1520224 (UMLS CUI [1])
laboratory test results
Item
5. laboratory test results within these ranges (unless due to leukemia): serum creatinine </= 2 mg/dl total bilirubin </= 2 mg/dl aspartate aminotransferase (ast) (sgot) and/or alanine aminotransferase (alt) (sgpt) </= 2.5 x uln or </= 5 times upper limit of normal (uln) if related to disease
boolean
C0022885 (UMLS CUI [1])
pregnancy, contracpetion
Item
6. women of childbearing potential (wcbp) must have a negative urine pregnancy test within 7 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. these methods include intra-uterine device, tubal ligation, partner's vasectomy, hormonal birth control pills. men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
pregnancy or lactation
Item
1. pregnant or breastfeeding females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk
Item
2. any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk.
boolean
C0009488 (UMLS CUI [1])
investigational drugs
Item
3. use of any other experimental drug or therapy for leukemia within 7 days unless there is clear evidence of rapid disease progression.
boolean
C0013230 (UMLS CUI [1])
hydroxyurea
Item
4. use of hydrea to control proliferative disease will be allowed prior to starting therapy on study and for up to 7 days each during cycle 1-3 (maximum daily dose of 7gm).
boolean
C0020402 (UMLS CUI [1])