ID

13750

Beskrivning

Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01133886

Länk

https://clinicaltrials.gov/show/NCT01133886

Nyckelord

Versioner (1)
  1. 2016-03-02 2016-03-02 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

2 mars 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01133886

Engelsk

Eligibility Acute Myeloid Leukemia NCT01133886

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written signed informed consent.
Beskrivning

1. written signed informed consent.

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. ≥18 years of age.
Beskrivning

2. ≥18 years of age.

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. diagnosed mds with 5% or more marrow blasts and ipss risk intermediate 2 or high risk; or chronic myelomonocytic leukemia (cmml-2); or aml with 20-30% bone marrow blasts.
Beskrivning

3. diagnosed mds with 5% or more marrow blasts and ipss risk intermediate 2 or high risk; or chronic myelomonocytic leukemia (cmml-2); or aml with 20-30% bone marrow blasts.

Datatyp

boolean

Alias
UMLS CUI [1]
C3463824
UMLS CUI [2]
C0023480
UMLS CUI [3]
C0023467
UMLS CUI [4]
C1982687
4. patients who have failed therapy with azacitidine.
Beskrivning

4. patients who have failed therapy with azacitidine.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004475
UMLS CUI [1,2]
C0438286
5. performance status 0-2 (ecog scale).
Beskrivning

5. performance status 0-2 (ecog scale).

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
6. adequate hepatic (bilirubin < 1.5 x uln or ast< 2.5 x uln) and renal functions (creatinine <1.5 x uln).
Beskrivning

6. adequate hepatic (bilirubin < 1.5 x uln or ast< 2.5 x uln) and renal functions (creatinine <1.5 x uln).

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201976
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

1. nursing and pregnant females.

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. females of childbearing potential and males not willing to practice an effective method of contraception whilst receiving decitabine and for 2 months after the last infusion.
Beskrivning

2. females of childbearing potential and males not willing to practice an effective method of contraception whilst receiving decitabine and for 2 months after the last infusion.

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
3. patients with previous malignancy or concurrent malignancy.
Beskrivning

3. patients with previous malignancy or concurrent malignancy.

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
4. uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure and unstable angina pectoris.
Beskrivning

4. uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure and unstable angina pectoris.

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
5. ongoing oral corticosteroids are not permitted. however, use of corticosteroids (topical and inhaled) is permitted and prophylactic steroids are allowed for transfusion reactions.
Beskrivning

5. ongoing oral corticosteroids are not permitted. however, use of corticosteroids (topical and inhaled) is permitted and prophylactic steroids are allowed for transfusion reactions.

Datatyp

boolean

Alias
UMLS CUI [1]
C0001617
6. patients who have received any investigational agent within the 30 days preceding the first dose of study drug.
Beskrivning

6. patients who have received any investigational agent within the 30 days preceding the first dose of study drug.

Datatyp

boolean

Alias
UMLS CUI [1]
C1875319
7. patients who have received prior intensive combination chemotherapy or high-dose cytarabine (>/= 1g/m*2 per dose). (prior biologic therapies, targeted therapies and single agent chemotherapy are allowed).
Beskrivning

7. patients who have received prior intensive combination chemotherapy or high-dose cytarabine (>/= 1g/m*2 per dose). (prior biologic therapies, targeted therapies and single agent chemotherapy are allowed).

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0010711
8. patients who have an active viral or bacterial infection. note: no patient is allowed to enter the study unless infections have been fully treated and the patient has remained afebrile for 7 days without antibiotics.
Beskrivning

8. patients who have an active viral or bacterial infection. note: no patient is allowed to enter the study unless infections have been fully treated and the patient has remained afebrile for 7 days without antibiotics.

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
9. patients who have concurrent autoimmune hemolytic anemia or immune thrombocytopenia.
Beskrivning

9. patients who have concurrent autoimmune hemolytic anemia or immune thrombocytopenia.

Datatyp

boolean

Alias
UMLS CUI [1]
C0002880
UMLS CUI [2]
C0272286
10. patients who have previously been treated with decitabine.
Beskrivning

10. patients who have previously been treated with decitabine.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0049065
UMLS CUI [1,2]
C1514463
11. patients who have known positive serology for hiv.
Beskrivning

11. patients who have known positive serology for hiv.

Datatyp

boolean

Alias
UMLS CUI [1]
C0019682
12. patients with a condition that may be unable to comply with the treatment and monitoring requirements of the study.
Beskrivning

12. patients with a condition that may be unable to comply with the treatment and monitoring requirements of the study.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Acute Myeloid Leukemia NCT01133886

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
1. written signed informed consent.
boolean
C0021430 (UMLS CUI [1])
age
Item
2. ≥18 years of age.
boolean
C0001779 (UMLS CUI [1])
MDS, CMML, AML
Item
3. diagnosed mds with 5% or more marrow blasts and ipss risk intermediate 2 or high risk; or chronic myelomonocytic leukemia (cmml-2); or aml with 20-30% bone marrow blasts.
boolean
C3463824 (UMLS CUI [1])
C0023480 (UMLS CUI [2])
C0023467 (UMLS CUI [3])
C1982687 (UMLS CUI [4])
failed therapy with azacitidine
Item
4. patients who have failed therapy with azacitidine.
boolean
C0004475 (UMLS CUI [1,1])
C0438286 (UMLS CUI [1,2])
ECOG
Item
5. performance status 0-2 (ecog scale).
boolean
C1520224 (UMLS CUI [1])
hepatic and renal function
Item
6. adequate hepatic (bilirubin < 1.5 x uln or ast< 2.5 x uln) and renal functions (creatinine <1.5 x uln).
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
nursing and pregnant females
Item
1. nursing and pregnant females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
childbearing potential, contraception
Item
2. females of childbearing potential and males not willing to practice an effective method of contraception whilst receiving decitabine and for 2 months after the last infusion.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
malignancy
Item
3. patients with previous malignancy or concurrent malignancy.
boolean
C0006826 (UMLS CUI [1])
comorbidity
Item
4. uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure and unstable angina pectoris.
boolean
C0009488 (UMLS CUI [1])
oral corticosteroids
Item
5. ongoing oral corticosteroids are not permitted. however, use of corticosteroids (topical and inhaled) is permitted and prophylactic steroids are allowed for transfusion reactions.
boolean
C0001617 (UMLS CUI [1])
investigational agent
Item
6. patients who have received any investigational agent within the 30 days preceding the first dose of study drug.
boolean
C1875319 (UMLS CUI [1])
chemotherapy
Item
7. patients who have received prior intensive combination chemotherapy or high-dose cytarabine (>/= 1g/m*2 per dose). (prior biologic therapies, targeted therapies and single agent chemotherapy are allowed).
boolean
C0392920 (UMLS CUI [1])
C0010711 (UMLS CUI [2])
infection
Item
8. patients who have an active viral or bacterial infection. note: no patient is allowed to enter the study unless infections have been fully treated and the patient has remained afebrile for 7 days without antibiotics.
boolean
C0009450 (UMLS CUI [1])
autoimmune hemolytic anemia or immune thrombocytopenia
Item
9. patients who have concurrent autoimmune hemolytic anemia or immune thrombocytopenia.
boolean
C0002880 (UMLS CUI [1])
C0272286 (UMLS CUI [2])
prior therapy with decitabine
Item
10. patients who have previously been treated with decitabine.
boolean
C0049065 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
hiv
Item
11. patients who have known positive serology for hiv.
boolean
C0019682 (UMLS CUI [1])
condition limiting study protocol
Item
12. patients with a condition that may be unable to comply with the treatment and monitoring requirements of the study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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