Informações:
Falhas:
ID
13170
Descrição
Trial of Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00760084
Link
https://clinicaltrials.gov/show/NCT00760084
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 NCT00760084
Eligibility Acute Myelogenous Leukemia NCT00760084
- StudyEvent: Eligibility
Similar models
Eligibility Acute Myelogenous Leukemia NCT00760084
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
informed consent
Item
1. must sign an institutional review board (irb) -approved informed consent form, indicating his/her awareness of the investigational nature of decitabine and its potential hazards prior to initiation of any study-specific procedures or treatment.
boolean
C0021430 (UMLS CUI [1])
MDS, CMML, AML
Item
2. must have had one of the following: mds (de novo or secondary) fitting any of the recognized french-american-british classifications chronic myelomonocytic leukemia (with wbc <12,000/μl) an international prognostic scoring system score of ≥1.5 as determined by complete blood count, bone marrow assessment and bone marrow cytogenetics within 30 days of study entry or aml (≥ 30 % bone marrow blasts), except m3 or acute promyelocytic leukemia.
boolean
C3463824 (UMLS CUI [1])
C0023480 (UMLS CUI [2])
C0023467 (UMLS CUI [3])
C0023480 (UMLS CUI [2])
C0023467 (UMLS CUI [3])
Age
Item
3. must be age 18 years or older.
boolean
C0001779 (UMLS CUI [1])
participation per protocol in the mgi pharma daco-018 decitabine trial
Item
4. must have completed participation per protocol in the mgi pharma daco-018 decitabine trial.
boolean
C2348568 (UMLS CUI [1])
s after discontinuation from the mgi pharma daco-018 trial
Item
5. must enroll in this trial no more than 8 weeks after discontinuation from the mgi pharma daco-018 trial.
boolean
C2348568 (UMLS CUI [1])
recovery from toxic effects
Item
6. must have recovered from all toxic effects of all prior therapy.
boolean
C2004454 (UMLS CUI [1])
malignancy
Item
1. must not have any other active malignancy, other than basal or squamous cell skin carcinoma.
boolean
C0006826 (UMLS CUI [1])
chemotherapy
Item
2. must not have received in the period after discontinuation from daco-018 and enrollment into this trial any other chemotherapy agent, including investigational agents, for their disease.
boolean
C0392920 (UMLS CUI [1])
comorbidity
Item
3. must not have evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial, at the discretion of the principal investigator.
boolean
C0009488 (UMLS CUI [1])
pregnancy or lactation
Item
4. must not be pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])