ID

30214

Description

Randomized Allogeneic Azacitidine Study; ODM derived from: https://clinicaltrials.gov/show/NCT00887068

Link

https://clinicaltrials.gov/show/NCT00887068

Keywords

Versions (1)
  1. 5/18/18 5/18/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 18, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00887068

English

Eligibility Leukemia NCT00887068

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00887068
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with a diagnosis of aml (world health organization classification: >=20% blasts in the bone marrow and / or peripheral blood) or mds (international prognostic scoring system intermediate-1 or higher) that at the time of allogeneic transplantation were in: - induction failure, relapsed disease or second or greater remission; patients in first complete remission that required more than 1 cycle of treatment to achieve the remission, or that have aml evolving from mds, or that had the following abnormalities: flt3 mutation, deletion of chromosome 5 or 7, mll gene rearrangement, or more than or equal to 3 cytogenetics abnormalities. patients with de novo or therapy-related mds, cmml, or aml are also eligible, regardless of cytogenetics or molecular rearrangements.
Description

AML WHO tumor classification | Blasts Bone marrow Percentage | Blasts Percentage Peripheral blood | MDS International Prognostic Scoring System | Transplantation, Homologous | Primary Induction Failure | Recurrent disease | Remission Number | FLT3 gene Mutation | Loss of Chromosome 5 | Loss of Chromosome 7 | MLL Gene Rearrangement | Chromosome Aberrations Quantity | Myelodysplastic syndrome de novo | Therapy-related myelodysplastic syndrome | CMML de novo | CMML Therapy Related | AML de novo | Treatment related AML

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1301142
UMLS CUI [2,1]
C1982687
UMLS CUI [2,2]
C0439165
UMLS CUI [3,1]
C0368761
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C0229664
UMLS CUI [4,1]
C3463824
UMLS CUI [4,2]
C2827405
UMLS CUI [5]
C0040739
UMLS CUI [6]
C2347677
UMLS CUI [7]
C0277556
UMLS CUI [8,1]
C0544452
UMLS CUI [8,2]
C0237753
UMLS CUI [9,1]
C1333568
UMLS CUI [9,2]
C0026882
UMLS CUI [10]
C1517985
UMLS CUI [11]
C1517989
UMLS CUI [12]
C1506987
UMLS CUI [13,1]
C0008625
UMLS CUI [13,2]
C1265611
UMLS CUI [14,1]
C3463824
UMLS CUI [14,2]
C1515568
UMLS CUI [15]
C1292780
UMLS CUI [16,1]
C0023480
UMLS CUI [16,2]
C1515568
UMLS CUI [17,1]
C0023480
UMLS CUI [17,2]
C0087111
UMLS CUI [17,3]
C0439849
UMLS CUI [18,1]
C0023467
UMLS CUI [18,2]
C1515568
UMLS CUI [19]
C1336735
2. biphenotypic leukemia that at the time of allogeneic transplantation was in induction failure, relapsed disease, first, second or greater remission.
Description

Acute biphenotypic leukemia | Transplantation, Homologous | Primary Induction Failure | Recurrent disease | Remission Number

Data type

boolean

Alias
UMLS CUI [1]
C0023464
UMLS CUI [2]
C0040739
UMLS CUI [3]
C2347677
UMLS CUI [4]
C0277556
UMLS CUI [5,1]
C0544452
UMLS CUI [5,2]
C0237753
3. patients must be in complete remission post transplant.
Description

In complete remission Post Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0677874
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0040732
4. patient may be enrolled 40 to 100 days after transplant.
Description

Enrollment Post Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0040732
5. age 18 to 75 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
6. serum creatinine < 1.8 mg/dl or creatinine clearance greater or equal than 40 cc/min as defined by the cockcroft-gault equation*. a. males(ml/min):(140-age)*ibw(kg) /
Description

Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
UMLS CUI [3]
C0079399
72*(serum creatinine(mg/dl)) b. females(ml/min):0.85*(140-age)*ibw(kg) / 72*(serum creatinine(mg/dl)).
Description

Creatinine measurement, serum | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
7. serum direct bilirubin < 1.5 mg/dl (unless gilbert's syndrome).
Description

Serum total bilirubin measurement | Exception Gilbert Disease

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0017551
8. sgpt </= 200 iu/ml unless related to patient's malignancy.
Description

Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
9. be able to understand and sign informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. active uncontrolled infection.
Description

Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
2. presence of uncontrolled graft-versus-host disease.
Description

Graft-vs-Host Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0018133
UMLS CUI [1,2]
C0205318
3. patients that underwent allogeneic transplantation as a treatment of graft failure.
Description

Transplantation, Homologous | Therapeutic procedure Graft failure

Data type

boolean

Alias
UMLS CUI [1]
C0040739
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1262018
4. pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is not post-menopausal with a positive serum pregnancy test.
Description

Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test positive | Menarche | Female Sterilization Absent | Postmenopausal state Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430063
UMLS CUI [4]
C0025274
UMLS CUI [5,1]
C0015787
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0232970
UMLS CUI [6,2]
C0332197
5. known or suspected hypersensitivity to azacitidine or mannitol.
Description

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

Data type

boolean

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

Malignant neoplasm of liver Advanced

Data type

boolean

Alias
UMLS CUI [1,1]
C0345904
UMLS CUI [1,2]
C0205179
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Similar models

Eligibility Leukemia NCT00887068

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00887068
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML WHO tumor classification | Blasts Bone marrow Percentage | Blasts Percentage Peripheral blood | MDS International Prognostic Scoring System | Transplantation, Homologous | Primary Induction Failure | Recurrent disease | Remission Number | FLT3 gene Mutation | Loss of Chromosome 5 | Loss of Chromosome 7 | MLL Gene Rearrangement | Chromosome Aberrations Quantity | Myelodysplastic syndrome de novo | Therapy-related myelodysplastic syndrome | CMML de novo | CMML Therapy Related | AML de novo | Treatment related AML
Item
1. patients with a diagnosis of aml (world health organization classification: >=20% blasts in the bone marrow and / or peripheral blood) or mds (international prognostic scoring system intermediate-1 or higher) that at the time of allogeneic transplantation were in: - induction failure, relapsed disease or second or greater remission; patients in first complete remission that required more than 1 cycle of treatment to achieve the remission, or that have aml evolving from mds, or that had the following abnormalities: flt3 mutation, deletion of chromosome 5 or 7, mll gene rearrangement, or more than or equal to 3 cytogenetics abnormalities. patients with de novo or therapy-related mds, cmml, or aml are also eligible, regardless of cytogenetics or molecular rearrangements.
boolean
C0023467 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
C1982687 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0368761 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0229664 (UMLS CUI [3,3])
C3463824 (UMLS CUI [4,1])
C2827405 (UMLS CUI [4,2])
C0040739 (UMLS CUI [5])
C2347677 (UMLS CUI [6])
C0277556 (UMLS CUI [7])
C0544452 (UMLS CUI [8,1])
C0237753 (UMLS CUI [8,2])
C1333568 (UMLS CUI [9,1])
C0026882 (UMLS CUI [9,2])
C1517985 (UMLS CUI [10])
C1517989 (UMLS CUI [11])
C1506987 (UMLS CUI [12])
C0008625 (UMLS CUI [13,1])
C1265611 (UMLS CUI [13,2])
C3463824 (UMLS CUI [14,1])
C1515568 (UMLS CUI [14,2])
C1292780 (UMLS CUI [15])
C0023480 (UMLS CUI [16,1])
C1515568 (UMLS CUI [16,2])
C0023480 (UMLS CUI [17,1])
C0087111 (UMLS CUI [17,2])
C0439849 (UMLS CUI [17,3])
C0023467 (UMLS CUI [18,1])
C1515568 (UMLS CUI [18,2])
C1336735 (UMLS CUI [19])
Acute biphenotypic leukemia | Transplantation, Homologous | Primary Induction Failure | Recurrent disease | Remission Number
Item
2. biphenotypic leukemia that at the time of allogeneic transplantation was in induction failure, relapsed disease, first, second or greater remission.
boolean
C0023464 (UMLS CUI [1])
C0040739 (UMLS CUI [2])
C2347677 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
C0544452 (UMLS CUI [5,1])
C0237753 (UMLS CUI [5,2])
In complete remission Post Transplantation
Item
3. patients must be in complete remission post transplant.
boolean
C0677874 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
Enrollment Post Transplantation
Item
4. patient may be enrolled 40 to 100 days after transplant.
boolean
C1516879 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
Age
Item
5. age 18 to 75 years old.
boolean
C0001779 (UMLS CUI [1])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Gender
Item
6. serum creatinine < 1.8 mg/dl or creatinine clearance greater or equal than 40 cc/min as defined by the cockcroft-gault equation*. a. males(ml/min):(140-age)*ibw(kg) /
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Creatinine measurement, serum | Gender
Item
72*(serum creatinine(mg/dl)) b. females(ml/min):0.85*(140-age)*ibw(kg) / 72*(serum creatinine(mg/dl)).
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Serum total bilirubin measurement | Exception Gilbert Disease
Item
7. serum direct bilirubin < 1.5 mg/dl (unless gilbert's syndrome).
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0017551 (UMLS CUI [2,2])
Alanine aminotransferase measurement
Item
8. sgpt </= 200 iu/ml unless related to patient's malignancy.
boolean
C0201836 (UMLS CUI [1])
Informed Consent
Item
9. be able to understand and sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Uncontrolled
Item
1. active uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Graft-vs-Host Disease Uncontrolled
Item
2. presence of uncontrolled graft-versus-host disease.
boolean
C0018133 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Transplantation, Homologous | Therapeutic procedure Graft failure
Item
3. patients that underwent allogeneic transplantation as a treatment of graft failure.
boolean
C0040739 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1262018 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test positive | Menarche | Female Sterilization Absent | Postmenopausal state Absent
Item
4. pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is not post-menopausal with a positive serum pregnancy test.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430063 (UMLS CUI [3,2])
C0025274 (UMLS CUI [4])
C0015787 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0232970 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Hypersensitivity Azacitidine | Mannitol allergy | Hypersensitivity Suspected Azacitidine | Mannitol allergy Suspected
Item
5. known or suspected hypersensitivity to azacitidine or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C0004475 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0004475 (UMLS CUI [3,3])
C0571922 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Malignant neoplasm of liver Advanced
Item
6. patients with advanced malignant hepatic tumors.
boolean
C0345904 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
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