Informações:
Falhas:
ID
14572
Descrição
Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Promyelocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01869803
Link
https://clinicaltrials.gov/show/NCT01869803
Palavras-chave
Versões (1)
- 21/04/2016 21/04/2016 -
Transferido a
21 de abril de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities NCT01869803
Eligibility Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities NCT01869803
- StudyEvent: Eligibility
Similar models
Eligibility Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities NCT01869803
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
relapsed or refractory aml
Item
diagnosis of relapsed or refractory aml and not candidate for standard consolidation treatment after daunorubicin and cytosine arabinoside or diagnosis of apl relapsed after tretinoin (atra) and arsenic trioxide therapy or apl with persisting or rising blasts, and no other comparable or satisfactory alternative therapy available (including patients not eligible for, or who have access to, investigational therapies via a clinical trial)
boolean
C2367456 (UMLS CUI [1])
Acute biphenotypic leukemia
Item
patients must have an initial diagnosis of aml, biphenotypic acute leukemia, or apl
boolean
C0023464 (UMLS CUI [1])
Clusters of differentiation
Item
patients must have cluster of differentiation (cd)33 positivity of > 30%
boolean
C1955216 (UMLS CUI [1])
eastern cooperative oncology group
Item
eastern cooperative oncology group (ecog) performance status =< 3 / karnofsky > 60%
boolean
C1512162 (UMLS CUI [1])
total bilirubin
Item
total bilirubin within normal institutional limits
boolean
C0201913 (UMLS CUI [1])
aspartate aminotransferase
Item
aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase [sgot])/alanine aminotransferase (alt) (serum glutamate pyruvate transaminase [sgpt]) =< 2 x institutional upper limit of normal
boolean
C0201899 (UMLS CUI [1])
experimental drug
Item
it is deemed ethical to provide an experimental drug (e.g., mylotarg) that is associated with hepatotoxicity (veno-occlusive disease [vod]) and myelosuppression
boolean
C0304229 (UMLS CUI [1])
contraception
Item
women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to receiving mylotarg and for the duration of treatment; should a woman become pregnant or suspect she is pregnant while receiving treatment with mylotarg, she should inform her treating physician immediately
boolean
C0420837 (UMLS CUI [1])
informed consent
Item
ability to understand and the willingness to sign a written institutional review board (irb)-approved informed consent document
boolean
C0021430 (UMLS CUI [1])
investigational agent
Item
patients may not currently be receiving any other investigational agents for leukemia
boolean
C0013230 (UMLS CUI [1])
hepatitis c
Item
patients with known untreated hepatitis c
boolean
C0019196 (UMLS CUI [1])
intercurrent illness
Item
uncontrolled intercurrent illness including, but not limited to active liver disease, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C3640977 (UMLS CUI [1])
pregnant women
Item
pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with mylotarg
boolean
C0032961 (UMLS CUI [1])
human immunodeficiency virus
Item
human immunodeficiency virus (hiv)-positive patients on combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
boolean
C0019682 (UMLS CUI [1])
hypersensitivity to gemtuzumab
Item
patients with a known hypersensitivity to gemtuzumab ozogamicin or its parts: recombinant humanized anti-cd33 monoclonal (hp67.6) antibody, calicheamicin derivatives or other ingredients
boolean
C0872968 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])