ID

30229

Beskrivning

5-Azacytidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01038635

Länk

https://clinicaltrials.gov/show/NCT01038635

Nyckelord

Versioner (2)
  1. 2018-05-22 2018-05-22 -
  2. 2018-05-22 2018-05-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 maj 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Leukemia NCT01038635

Engelsk

Eligibility Leukemia NCT01038635

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01038635
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with higher risk mds (bone marrow blasts >/= 10% to 30% inclusive) of any age who refuse or are not eligible for frontline chemotherapy.
Beskrivning

MYELODYSPLASTIC SYNDROME High risk | Blasts Bone marrow Percent | Age | First line Chemotherapy Refused | Ineligibility First line Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3463824
UMLS CUI [1,2]
C0332167
UMLS CUI [2,1]
C1982687
UMLS CUI [2,2]
C0439165
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C1708063
UMLS CUI [4,2]
C0392920
UMLS CUI [4,3]
C1705116
UMLS CUI [5,1]
C1512714
UMLS CUI [5,2]
C1708063
UMLS CUI [5,3]
C0392920
2. no prior therapy for higher risk mds as defined above.
Beskrivning

Prior Therapy Absent MYELODYSPLASTIC SYNDROME High risk

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C3463824
UMLS CUI [1,4]
C0332167
3. performance status of </= 2 by the ecog scale.
Beskrivning

Performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1518965
4. signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of utmdacc.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
5. hydroxyurea for patients with rapidly proliferative disease can be used up to 24 hours prior to therapy but not concomitantly with 5-azacitidine or lenalidomide. hydroxyurea can be used once the patient has completed the planned 5 azacitidine and lenalidomide treatment.
Beskrivning

Hydroxyurea | Disease Proliferative Rapidly | Azacitidine Discontinued | Lenalidomide Discontinued

Datatyp

boolean

Alias
UMLS CUI [1]
C0020402
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0334094
UMLS CUI [2,3]
C0456962
UMLS CUI [3,1]
C0004475
UMLS CUI [3,2]
C1444662
UMLS CUI [4,1]
C1144149
UMLS CUI [4,2]
C1444662
6. adequate liver function: total bilirubin of </= 1.5 x uln, ast (sgot) and alt (sgpt) </= 3 x uln
Beskrivning

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
7. renal function - assessed by calculated creatinine clearance as follows (see appendix: cockcroft-gault estimation of crcl): 1. phase i subjects must have calculated creatinine clearance >/= 60ml/min by cockcroft-gault formula. 2. phase ii subjects must have calculated creatinine clearance >/= 30ml/min by cockcroft-gault formula.
Beskrivning

Renal function | Phase Number Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2,1]
C0205390
UMLS CUI [2,2]
C0237753
UMLS CUI [2,3]
C2711451
8. all study participants must be registered into the mandatory revlimid rems® program, and be willing and able to comply with the requirements of revlimid rems®.
Beskrivning

Study Subject Participation Status | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0525058
9. females of reproductive potential must adhere to the scheduled pregnancy testing as required in the revlimid rems® program.
Beskrivning

Childbearing Potential Pregnancy Tests

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
10. able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to asa may use warfarin or low molecular weight heparin).
Beskrivning

Able to take Aspirin Dosage Daily | Use of anticoagulation Prophylactic | Intolerance to Aspirin | Warfarin | Heparin, Low-Molecular-Weight

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4075001
UMLS CUI [1,2]
C0004057
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0332173
UMLS CUI [2,1]
C0449867
UMLS CUI [2,2]
C0199176
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0004057
UMLS CUI [4]
C0043031
UMLS CUI [5]
C0019139
11. females of childbearing potential (fcbp) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 miu/ml within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide. fcbp must also agree to ongoing pregnancy testing.
Beskrivning

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Prescription Lenalidomide | Childbearing Potential Abstinence Coitus | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Pregnancy Tests

Datatyp

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]
C0033080
UMLS CUI [3,2]
C1144149
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0036899
UMLS CUI [4,3]
C0009253
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0700589
UMLS CUI [5,3]
C1265611
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0032976
12. continued from #9: men must agree to use a latex condom during sexual contact with a fcbp even if they have had a successful vasectomy.
Beskrivning

Gender Latex condom | Coitus Gender Childbearing Potential | Vasectomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3873750
UMLS CUI [2,1]
C0009253
UMLS CUI [2,2]
C0079399
UMLS CUI [2,3]
C3831118
UMLS CUI [3]
C0042387
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. nursing and pregnant females.
Beskrivning

Breast Feeding | Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
2. known or suspected hypersensitivity to azacitidine or mannitol.
Beskrivning

Hypersensitivity Azacitidine | Hypersensitivity Suspected Azacitidine | Mannitol allergy | Mannitol allergy Suspected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004475
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0004475
UMLS CUI [3]
C0571922
UMLS CUI [4,1]
C0571922
UMLS CUI [4,2]
C0750491
3. patients with advanced malignant hepatic tumors.
Beskrivning

Malignant neoplasm of liver Advanced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0345904
UMLS CUI [1,2]
C0205179
4. unwilling or unable to remain in compliance with the revassist® program
Beskrivning

Protocol Compliance Unwilling | Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
5. known hypersensitivity to thalidomide or lenalidomide (if applicable).
Beskrivning

Hypersensitivity Thalidomide | Hypersensitivity Lenalidomide

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1144149
6. the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Beskrivning

Erythema Nodosum | Rash desquamating | Thalidomide | Pharmaceutical Preparations Similar

Datatyp

boolean

Alias
UMLS CUI [1]
C0014743
UMLS CUI [2]
C0542171
UMLS CUI [3]
C0039736
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C2348205
7. known seropositive for or active viral infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv). patients who are seropositive because of hepatitis b virus vaccine are eligible.
Beskrivning

HIV Seropositivity | HIV Infection | Hepatitis B Seropositive | Hepatitis C Seropositive | Hepatitis B | Hepatitis C | Hepatitis B Virus Vaccine allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019693
UMLS CUI [3,1]
C0019163
UMLS CUI [3,2]
C0521143
UMLS CUI [4,1]
C0019196
UMLS CUI [4,2]
C0521143
UMLS CUI [5]
C0019163
UMLS CUI [6]
C0019196
UMLS CUI [7,1]
C0019169
UMLS CUI [7,2]
C0042210
UMLS CUI [7,3]
C0683607
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Similar models

Eligibility Leukemia NCT01038635

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01038635
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
MYELODYSPLASTIC SYNDROME High risk | Blasts Bone marrow Percent | Age | First line Chemotherapy Refused | Ineligibility First line Chemotherapy
Item
1. patients with higher risk mds (bone marrow blasts >/= 10% to 30% inclusive) of any age who refuse or are not eligible for frontline chemotherapy.
boolean
C3463824 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C1982687 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C1708063 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
C1705116 (UMLS CUI [4,3])
C1512714 (UMLS CUI [5,1])
C1708063 (UMLS CUI [5,2])
C0392920 (UMLS CUI [5,3])
Prior Therapy Absent MYELODYSPLASTIC SYNDROME High risk
Item
2. no prior therapy for higher risk mds as defined above.
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3463824 (UMLS CUI [1,3])
C0332167 (UMLS CUI [1,4])
Performance status
Item
3. performance status of </= 2 by the ecog scale.
boolean
C1518965 (UMLS CUI [1])
Informed Consent
Item
4. signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of utmdacc.
boolean
C0021430 (UMLS CUI [1])
Hydroxyurea | Disease Proliferative Rapidly | Azacitidine Discontinued | Lenalidomide Discontinued
Item
5. hydroxyurea for patients with rapidly proliferative disease can be used up to 24 hours prior to therapy but not concomitantly with 5-azacitidine or lenalidomide. hydroxyurea can be used once the patient has completed the planned 5 azacitidine and lenalidomide treatment.
boolean
C0020402 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0334094 (UMLS CUI [2,2])
C0456962 (UMLS CUI [2,3])
C0004475 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1144149 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
6. adequate liver function: total bilirubin of </= 1.5 x uln, ast (sgot) and alt (sgpt) </= 3 x uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Renal function | Phase Number Estimation of creatinine clearance by Cockcroft-Gault formula
Item
7. renal function - assessed by calculated creatinine clearance as follows (see appendix: cockcroft-gault estimation of crcl): 1. phase i subjects must have calculated creatinine clearance >/= 60ml/min by cockcroft-gault formula. 2. phase ii subjects must have calculated creatinine clearance >/= 30ml/min by cockcroft-gault formula.
boolean
C0232804 (UMLS CUI [1])
C0205390 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C2711451 (UMLS CUI [2,3])
Study Subject Participation Status | Protocol Compliance
Item
8. all study participants must be registered into the mandatory revlimid rems® program, and be willing and able to comply with the requirements of revlimid rems®.
boolean
C2348568 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Childbearing Potential Pregnancy Tests
Item
9. females of reproductive potential must adhere to the scheduled pregnancy testing as required in the revlimid rems® program.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Able to take Aspirin Dosage Daily | Use of anticoagulation Prophylactic | Intolerance to Aspirin | Warfarin | Heparin, Low-Molecular-Weight
Item
10. able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to asa may use warfarin or low molecular weight heparin).
boolean
C4075001 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
C0449867 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0004057 (UMLS CUI [3,2])
C0043031 (UMLS CUI [4])
C0019139 (UMLS CUI [5])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Prescription Lenalidomide | Childbearing Potential Abstinence Coitus | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Pregnancy Tests
Item
11. females of childbearing potential (fcbp) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 miu/ml within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide. fcbp must also agree to ongoing pregnancy testing.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C0033080 (UMLS CUI [3,1])
C1144149 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C0009253 (UMLS CUI [4,3])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C3831118 (UMLS CUI [6,1])
C0032976 (UMLS CUI [6,2])
Gender Latex condom | Coitus Gender Childbearing Potential | Vasectomy
Item
12. continued from #9: men must agree to use a latex condom during sexual contact with a fcbp even if they have had a successful vasectomy.
boolean
C0079399 (UMLS CUI [1,1])
C3873750 (UMLS CUI [1,2])
C0009253 (UMLS CUI [2,1])
C0079399 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0042387 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Breast Feeding | Pregnancy
Item
1. nursing and pregnant females.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Hypersensitivity Azacitidine | Hypersensitivity Suspected Azacitidine | Mannitol allergy | Mannitol allergy Suspected
Item
2. known or suspected hypersensitivity to azacitidine or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C0004475 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0004475 (UMLS CUI [2,3])
C0571922 (UMLS CUI [3])
C0571922 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Malignant neoplasm of liver Advanced
Item
3. patients with advanced malignant hepatic tumors.
boolean
C0345904 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
4. unwilling or unable to remain in compliance with the revassist® program
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Hypersensitivity Thalidomide | Hypersensitivity Lenalidomide
Item
5. known hypersensitivity to thalidomide or lenalidomide (if applicable).
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1144149 (UMLS CUI [2,2])
Erythema Nodosum | Rash desquamating | Thalidomide | Pharmaceutical Preparations Similar
Item
6. the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
boolean
C0014743 (UMLS CUI [1])
C0542171 (UMLS CUI [2])
C0039736 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C2348205 (UMLS CUI [4,2])
HIV Seropositivity | HIV Infection | Hepatitis B Seropositive | Hepatitis C Seropositive | Hepatitis B | Hepatitis C | Hepatitis B Virus Vaccine allowed
Item
7. known seropositive for or active viral infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv). patients who are seropositive because of hepatitis b virus vaccine are eligible.
boolean
C0019699 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0019163 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
C0019196 (UMLS CUI [4,1])
C0521143 (UMLS CUI [4,2])
C0019163 (UMLS CUI [5])
C0019196 (UMLS CUI [6])
C0019169 (UMLS CUI [7,1])
C0042210 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
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