ID
13754
Descripción
Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01149408
Link
https://clinicaltrials.gov/show/NCT01149408
Palabras clave
Versiones (1)
- 3/3/16 3/3/16 -
Titular de derechos de autor
CC BY-NC 3.0
Subido en
3 de marzo de 2016
DOI
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Licencia
Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01149408
Eligibility Acute Myeloid Leukemia NCT01149408
- StudyEvent: Eligibility
Descripción
Exclusion Criteria
Alias
- UMLS CUI
- C0680251
Descripción
1. diagnosis of acute promyelocytic leukemia (apl, who classification of apl with t(15;17)(q22;q12)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0023487
Descripción
2. prior diagnosis and treatment for aml, including hematopoietic stem cell transplant (hsct)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0023467
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [2,1]
- C0472699
- UMLS CUI [2,2]
- C1514463
Descripción
3. previous therapy with a hypomethylating agent including decitabine or azacitidine (i.e. for an antecedent myelodysplastic syndrome)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2613367
- UMLS CUI [1,2]
- C0013227
Descripción
4. any prior therapy for aml except for hydroxyurea for the control of blood counts
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0023467
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [2]
- C0020402
Descripción
5. psychiatric disorders that would interfere with consent, study participation, or follow-up
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
- UMLS CUI [1,3]
- C0009488
Descripción
6. cardiac disease: heart failure nyha class 3 or 4; unstable coronary artery disease (mi more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1275491
- UMLS CUI [2,1]
- C0010068
- UMLS CUI [2,2]
- C0443343
- UMLS CUI [3]
- C0085612
- UMLS CUI [4]
- C1979623
- UMLS CUI [5,1]
- C0027051
- UMLS CUI [5,2]
- C0011008
- UMLS CUI [6]
- C0001645
- UMLS CUI [7]
- C0012265
Descripción
7. chronically impaired renal function (creatinine clearance < 30 ml / min)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0373595
Descripción
8. inadequate liver function (alt and ast ≥ 2.5 x uln) if not caused by leukemic infiltration
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0201836
- UMLS CUI [2]
- C0201899
Descripción
9. total bilirubin ≥ 1.5 x uln if not caused by leukemic infiltration
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1278039
Descripción
10. known hiv and/or hepatitis c infection
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0019682
- UMLS CUI [2]
- C0019196
Descripción
11. evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0005779
Descripción
12. evidence or recent history of cns disease, including primary or metastatic brain tumors, seizure disorders
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0007682
Descripción
13. clinical evidence suggestive of central nervous system (cns) involvement with leukemia unless a lumbar puncture confirms the absence of leukemic blasts in the cerebrospinal fluid (csf)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1332884
- UMLS CUI [2,1]
- C0368761
- UMLS CUI [2,2]
- C0007806
Descripción
14. any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo therapy on this protocol
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
- UMLS CUI [1,3]
- C0009488
Descripción
15. systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0009450
Descripción
16. diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions: patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (psa) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0006826
- UMLS CUI [2]
- C0007099
- UMLS CUI [3]
- C0699893
- UMLS CUI [4]
- C0206708
- UMLS CUI [5]
- C0600139
Descripción
17. history of organ allograft
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0178784
Descripción
18. any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
- UMLS CUI [1,3]
- C0009488
Descripción
19. patients who have an indication for and can undergo a non-myeloablative transplant procedure
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1831742
Similar models
Eligibility Acute Myeloid Leukemia NCT01149408
- StudyEvent: Eligibility
C1515568 (UMLS CUI [1,2])
C0677874 (UMLS CUI [1,3])
C0280449 (UMLS CUI [2,1])
C0677874 (UMLS CUI [2,2])
C0023487 (UMLS CUI [3])
C0010711 (UMLS CUI [4])
C0020789 (UMLS CUI [5])
C0677874 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C1514463 (UMLS CUI [1,2])
C0472699 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C0013227 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,2])
C0020402 (UMLS CUI [2])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0010068 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0085612 (UMLS CUI [3])
C1979623 (UMLS CUI [4])
C0027051 (UMLS CUI [5,1])
C0011008 (UMLS CUI [5,2])
C0001645 (UMLS CUI [6])
C0012265 (UMLS CUI [7])
C0201899 (UMLS CUI [2])
C0019196 (UMLS CUI [2])
C0368761 (UMLS CUI [2,1])
C0007806 (UMLS CUI [2,2])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0007099 (UMLS CUI [2])
C0699893 (UMLS CUI [3])
C0206708 (UMLS CUI [4])
C0600139 (UMLS CUI [5])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])