Information:
Fel:
ID
14026
Beskrivning
Allogeneic Transplantation Using Timed Sequential Busulfan, Cladribine, and Fludarabine Conditioning in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT02250937
Länk
https://clinicaltrials.gov/show/NCT02250937
Nyckelord
Versioner (1)
- 2016-03-22 2016-03-22 -
Uppladdad den
22 mars 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT02250937
Eligibility Acute Myeloid Leukemia NCT02250937
- StudyEvent: Eligibility
Similar models
Eligibility Acute Myeloid Leukemia NCT02250937
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
AML, MDS
Item
Patients with acute myeloid leukemia or myelodysplastic syndrome not in complete remission (patients with disease detectable only by flow cytometry, cytogenetics, or molecular studies are eligible).
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
C3463824 (UMLS CUI [2])
Hla-identical
Item
Hla-identical sibling or 8/8 matched unrelated donor transplant.
boolean
C0019721 (UMLS CUI [1])
C0398534 (UMLS CUI [2])
C0398534 (UMLS CUI [2])
Age
Item
Patients age 18 to 70 years old. Eligibility for pediatric patients will be determined in conjunction with an mdacc pediatrician. patients age 2-17 years old may be enrolled after at least 10 adults (ages 18-70 years old) have been assessed for safety at day 30, as defined in the statistical considerations section.
boolean
C0001779 (UMLS CUI [1])
Direct bilirubin
Item
Direct bilirubin < 1 mg/dl and alt < 3 times upper limit of normal.
boolean
C0201916 (UMLS CUI [1])
Creatinine clearance
Item
Creatinine clearance > 50 ml/min (calculated creatinine clearance is permitted).
boolean
C0812399 (UMLS CUI [1])
Pulmonary function
Item
Adequate pulmonary function with fev1, fvc and dlco >/=50% of expected corrected for hemoglobin and/or volume. children unable to perform pulmonary function tests (e.g., less than 7 years old) pulse oximetry of >/= 92% on room air.
boolean
C0231921 (UMLS CUI [1])
Left ventricular ejection fraction
Item
Lvef >/= 40%.
boolean
C0428772 (UMLS CUI [1])
Informed Consent
Item
Able to sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Negative beta hcg
Item
Negative beta hcg test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. women of child bearing potential must be willing to use an effective contraceptive measure while on study.
boolean
C0121166 (UMLS CUI [1])
Performance score
Item
Performance score of >/= 70 by karnofsky/lansky or ps 0 to 1 (ecog </=1).
boolean
C2053069 (UMLS CUI [1])
Allogeneic or autologous transplantation
Item
Prior allogeneic or autologous transplantation.
boolean
C3899991 (UMLS CUI [1])
Infection
Item
Uncontrolled infections.
boolean
C3714514 (UMLS CUI [1])
HIV positive
Item
HIV Seropositivity
boolean
C0019699 (UMLS CUI [1])