ID

41070

Beschrijving

Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT01289457

Link

https://clinicaltrials.gov/show/NCT01289457

Trefwoorden

Versies (1)
  1. 19-06-20 19-06-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 juni 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Leukemia NCT01289457

Engels

Eligibility Leukemia NCT01289457

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01289457
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. sign an irb-approved informed consent document.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
2. age 18 to 60. patients above the age of 60 only with principal investigator (pi) approval
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. diagnosis of newly diagnosed aml [other than acute promyelocytic leukemia (apl)] or high-risk (intermediate-2 or high by ipss or > 10% blasts, including cmml) mds. prior therapy with hydrea and the use of a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use up to 24 hours prior to start of study therapy is allowed. prior therapy for mds or other ahd is not allowed.
Beschrijving

Leukemia, Myelocytic, Acute | Exception Acute Promyelocytic Leukemia | High risk MYELODYSPLASTIC SYNDROME IPSS | Blasts Percentage | Leukemia, Myelomonocytic, Chronic | Hydrea | Cytarabine Dose U/day

Datatype

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0023487
UMLS CUI [3,1]
C4319571
UMLS CUI [3,2]
C3463824
UMLS CUI [3,3]
C2827405
UMLS CUI [4,1]
C0368761
UMLS CUI [4,2]
C0439165
UMLS CUI [5]
C0023480
UMLS CUI [6]
C0591617
UMLS CUI [7,1]
C0010711
UMLS CUI [7,2]
C0178602
UMLS CUI [7,3]
C0456683
4. ecog performance status of </= 3 at study entry.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
5. organ function as defined below (unless due to leukemia): serum creatinine </= 3 mg/dl total bilirubin </= 2.5 mg/dl , alt (sgpt) </= 3 * uln or </= 5 * uln if related to disease.
Beschrijving

Organ function | Exception Due to Leukemia | Creatinine measurement, serum | Serum total bilirubin measurement | Alanine aminotransferase measurement | Relationship Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0023418
UMLS CUI [3]
C0201976
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201836
UMLS CUI [6,1]
C0439849
UMLS CUI [6,2]
C0012634
6. women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and must agree to practice acceptable contraceptive methods. men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
Beschrijving

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods | Gender Preventing Reproduction | Gender Use of Condom | Partner Childbearing Potential

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0035150
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C1524063
UMLS CUI [5,3]
C0009653
UMLS CUI [6,1]
C0682323
UMLS CUI [6,2]
C3831118
7. cardiac ejection fraction >/= 40% (by either cardiac echo or muga scan). documentation of recent (</= 6 months from screening) outside reports is acceptable.
Beschrijving

Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MUGA scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0521317
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. breast feeding females
Beschrijving

Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
2. patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible).
Beschrijving

Communicable Diseases Uncontrolled | Virus Diseases | Bacterial Infections | Mycoses

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0042769
UMLS CUI [3]
C0004623
UMLS CUI [4]
C0026946
3. patients with active secondary malignancy will not be eligible.
Beschrijving

Secondary Malignant Neoplasm

Datatype

boolean

Alias
UMLS CUI [1]
C3266877
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Similar models

Eligibility Leukemia NCT01289457

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01289457
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. sign an irb-approved informed consent document.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age 18 to 60. patients above the age of 60 only with principal investigator (pi) approval
boolean
C0001779 (UMLS CUI [1])
Leukemia, Myelocytic, Acute | Exception Acute Promyelocytic Leukemia | High risk MYELODYSPLASTIC SYNDROME IPSS | Blasts Percentage | Leukemia, Myelomonocytic, Chronic | Hydrea | Cytarabine Dose U/day
Item
3. diagnosis of newly diagnosed aml [other than acute promyelocytic leukemia (apl)] or high-risk (intermediate-2 or high by ipss or > 10% blasts, including cmml) mds. prior therapy with hydrea and the use of a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use up to 24 hours prior to start of study therapy is allowed. prior therapy for mds or other ahd is not allowed.
boolean
C0023467 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0023487 (UMLS CUI [2,2])
C4319571 (UMLS CUI [3,1])
C3463824 (UMLS CUI [3,2])
C2827405 (UMLS CUI [3,3])
C0368761 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0023480 (UMLS CUI [5])
C0591617 (UMLS CUI [6])
C0010711 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0456683 (UMLS CUI [7,3])
ECOG performance status
Item
4. ecog performance status of </= 3 at study entry.
boolean
C1520224 (UMLS CUI [1])
Organ function | Exception Due to Leukemia | Creatinine measurement, serum | Serum total bilirubin measurement | Alanine aminotransferase measurement | Relationship Disease
Item
5. organ function as defined below (unless due to leukemia): serum creatinine </= 3 mg/dl total bilirubin </= 2.5 mg/dl , alt (sgpt) </= 3 * uln or </= 5 * uln if related to disease.
boolean
C0678852 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0023418 (UMLS CUI [2,3])
C0201976 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0439849 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods | Gender Preventing Reproduction | Gender Use of Condom | Partner Childbearing Potential
Item
6. women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and must agree to practice acceptable contraceptive methods. men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0035150 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5,1])
C1524063 (UMLS CUI [5,2])
C0009653 (UMLS CUI [5,3])
C0682323 (UMLS CUI [6,1])
C3831118 (UMLS CUI [6,2])
Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MUGA scan
Item
7. cardiac ejection fraction >/= 40% (by either cardiac echo or muga scan). documentation of recent (</= 6 months from screening) outside reports is acceptable.
boolean
C0232174 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Breast Feeding
Item
1. breast feeding females
boolean
C0006147 (UMLS CUI [1])
Communicable Diseases Uncontrolled | Virus Diseases | Bacterial Infections | Mycoses
Item
2. patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible).
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2])
C0004623 (UMLS CUI [3])
C0026946 (UMLS CUI [4])
Secondary Malignant Neoplasm
Item
3. patients with active secondary malignancy will not be eligible.
boolean
C3266877 (UMLS CUI [1])
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