ID

24697

Beschreibung

Oxaliplatin, Fludarabine, and Cytarabine in Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT00480987

Link

https://clinicaltrials.gov/show/NCT00480987

Stichworte

Versionen (1)
  1. 13.08.17 13.08.17 -
Hochgeladen am

13. August 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Myelodysplastic Syndromes NCT00480987

Englisch

Eligibility Myelodysplastic Syndromes NCT00480987

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (aml) or high-risk myelodysplastic syndrome.
Beschreibung

Recurrent adult acute myeloid leukemia | Acute Myelocytic Leukemia refractory | Myelodysplastic syndrome High risk

Datentyp

boolean

Alias
UMLS CUI [1]
C0278780
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C3463824
UMLS CUI [3,2]
C0332167
performance status 0-2 (zubrod scale).
Beschreibung

Zubrod Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C3714786
serum creatinine equal or less than 1.3 mg/dl or creatinine clearance > 40 ml/min.
Beschreibung

Creatinine measurement, serum | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
bilirubin </= 2 mg/dl; serum glutamic oxaloacetic transaminase (sgot) or serum glutamic pyruvic transaminase (sgpt) </= 3 times the upper limit of normal (uln) for the reference lab unless due to leukemia or congenital hemolytic disorder (for bilirubin).
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
written informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
no untreated or uncontrolled life-threatening infection.
Beschreibung

Life-threatening infection untreated | Life-threatening infection Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1859430
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1859430
UMLS CUI [2,2]
C0205318
no oxaliplatin, fludarabine, or cytarabine intolerance.
Beschreibung

Intolerance to oxaliplatin | Intolerance to fludarabine | Intolerance to Cytarabine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0069717
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0059985
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0010711
no pregnancy or lactation. female patients of childbearing potential (including those < 1 year post-menopausal) and male patients must agree to use contraception.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Postmenopausal state Duration Contraceptive methods | Gender Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0232970
UMLS CUI [4,2]
C0449238
UMLS CUI [4,3]
C0700589
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0700589
no chemotherapy or radiation therapy within 4 weeks of study entry. hydroxyurea is allowed prior to starting therapy in the setting of rapidly proliferating disease.
Beschreibung

Chemotherapy | Therapeutic radiology procedure | Hydroxyurea pre treatment allowed | Disease Proliferating Rapidly

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C0020402
UMLS CUI [3,2]
C2709094
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1514485
UMLS CUI [4,3]
C0456962
no other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent or cooperate and participate in the study or to interfere with the interpretation of the results.
Beschreibung

Medical condition Interferes with Informed Consent | Medical condition Interferes with Compliance behavior | Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Interpretation Research results | Mental disorder | Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1321605
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0459471
UMLS CUI [4,4]
C0683954
UMLS CUI [5]
C0004936
UMLS CUI [6]
C0038586
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Ähnliche Modelle

Eligibility Myelodysplastic Syndromes NCT00480987

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent adult acute myeloid leukemia | Acute Myelocytic Leukemia refractory | Myelodysplastic syndrome High risk
Item
histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (aml) or high-risk myelodysplastic syndrome.
boolean
C0278780 (UMLS CUI [1])
C0023467 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C3463824 (UMLS CUI [3,1])
C0332167 (UMLS CUI [3,2])
Zubrod Performance Status
Item
performance status 0-2 (zubrod scale).
boolean
C3714786 (UMLS CUI [1])
Creatinine measurement, serum | Creatinine clearance measurement
Item
serum creatinine equal or less than 1.3 mg/dl or creatinine clearance > 40 ml/min.
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin </= 2 mg/dl; serum glutamic oxaloacetic transaminase (sgot) or serum glutamic pyruvic transaminase (sgpt) </= 3 times the upper limit of normal (uln) for the reference lab unless due to leukemia or congenital hemolytic disorder (for bilirubin).
boolean
C1278039 (UMLS CUI [1])
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Life-threatening infection untreated | Life-threatening infection Uncontrolled
Item
no untreated or uncontrolled life-threatening infection.
boolean
C1859430 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1859430 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Intolerance to oxaliplatin | Intolerance to fludarabine | Intolerance to Cytarabine
Item
no oxaliplatin, fludarabine, or cytarabine intolerance.
boolean
C1744706 (UMLS CUI [1,1])
C0069717 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0059985 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0010711 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Postmenopausal state Duration Contraceptive methods | Gender Contraceptive methods
Item
no pregnancy or lactation. female patients of childbearing potential (including those < 1 year post-menopausal) and male patients must agree to use contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Chemotherapy | Therapeutic radiology procedure | Hydroxyurea pre treatment allowed | Disease Proliferating Rapidly
Item
no chemotherapy or radiation therapy within 4 weeks of study entry. hydroxyurea is allowed prior to starting therapy in the setting of rapidly proliferating disease.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0020402 (UMLS CUI [3,1])
C2709094 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C1514485 (UMLS CUI [4,2])
C0456962 (UMLS CUI [4,3])
Medical condition Interferes with Informed Consent | Medical condition Interferes with Compliance behavior | Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Interpretation Research results | Mental disorder | Substance Use Disorders
Item
no other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent or cooperate and participate in the study or to interfere with the interpretation of the results.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0459471 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
C0004936 (UMLS CUI [5])
C0038586 (UMLS CUI [6])
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