ID

24514

Description

Study of Temozolomide in Previously Untreated Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression (P05052); ODM derived from: https://clinicaltrials.gov/show/NCT00687323

Link

https://clinicaltrials.gov/show/NCT00687323

Keywords

Versions (1)
  1. 8/4/17 8/4/17 -
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August 4, 2017

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia, Acute Myeloid NCT00687323

English

Eligibility Leukemia, Acute Myeloid NCT00687323

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of acute myeloid leukemia (aml), any subtype except acute promyelocytic leukemia (apl), by the world health organization (who) criteria, or high risk mds with blasts between 10 and 20% in the bone marrow.
Description

Acute Myelocytic Leukemia Subtype Any | Acute Promyelocytic Leukemia Excluded | MYELODYSPLASTIC SYNDROME High risk | Blasts Bone marrow Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0449560
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C0023487
UMLS CUI [2,2]
C2828389
UMLS CUI [3,1]
C3463824
UMLS CUI [3,2]
C0332167
UMLS CUI [4,1]
C1982687
UMLS CUI [4,2]
C0439165
no prior aml chemotherapy except hydroxyurea.
Description

Chemotherapy Absent AML | hydroxyurea

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0023467
UMLS CUI [2]
C0020402
leukemic blast count <30x10^9/l at the start of therapy. prior cytoreduction with hydroxyurea (maximum 14 days) is permitted.
Description

Leukemic Blast Count | Hydroxyurea Cytoreductive effect

Data type

boolean

Alias
UMLS CUI [1]
C2697913
UMLS CUI [2,1]
C0020402
UMLS CUI [2,2]
C0864494
participant is not a candidate for aggressive induction based on at least one of the following: adverse-risk cytogenetics (complete or partial deletion of 5 or 7, complex [>3] cytogenetic abnormalities, inv3, 11q23 abnormalities); secondary aml (antecedent hematologic disorder or therapy-related aml); comorbid medical illnesses precluding standard induction therapy; participant's refusal of standard induction therapy.
Description

Induction procedure intense Unfavorable | Risk Cytogenetic | Chromosome Deletion Complete | Chromosome Deletion Partial | Chromosome Aberrations | inv(3) Abnormality | Chromosome 11q23 Abnormality | secondary acute myeloid leukemia | Hematological Disease | Comorbidity Excludes Induction procedure | Induction procedure Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0857127
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0010802
UMLS CUI [3,1]
C0008628
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C0008628
UMLS CUI [4,2]
C0728938
UMLS CUI [5]
C0008625
UMLS CUI [6,1]
C3829508
UMLS CUI [6,2]
C1704258
UMLS CUI [7,1]
C0796367
UMLS CUI [7,2]
C1704258
UMLS CUI [8]
C0280449
UMLS CUI [9]
C0018939
UMLS CUI [10,1]
C0009488
UMLS CUI [10,2]
C0332196
UMLS CUI [10,3]
C0857127
UMLS CUI [11,1]
C0857127
UMLS CUI [11,2]
C1705116
confirmed low mgmt expression (mgmt: beta-actin ≤0.2), as evaluated by western blot, or weak mgmt expression defined as > 0.2 and ≤2.5 if promoter is methylated, upon sponsor approval.
Description

MGMT expression low Western Blotting | beta-Actin | MGMT expression weak

Data type

boolean

Alias
UMLS CUI [1,1]
C0069197
UMLS CUI [1,2]
C1171362
UMLS CUI [1,3]
C0205251
UMLS CUI [1,4]
C0005863
UMLS CUI [2]
C0005186
UMLS CUI [3,1]
C0069197
UMLS CUI [3,2]
C1171362
UMLS CUI [3,3]
C1762617
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
use of medically approved contraception in fertile males and females.
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
negative urine or serum pregnancy test for women of childbearing potential (72 hours prior to baseline).
Description

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
serum bilirubin >2 times the upper limit of normal (uln), or serum aspartate aminotransferase/ alanine aminotransferase >5 times uln.
Description

Serum bilirubin increased | Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0859062
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
serum creatinine >200 umol/l.
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
history of other malignancies within 1 year prior to study entry, with the exception of localized nonmelanomatous skin cancer or cervical cancer in situ.
Description

Malignant Neoplasms | Skin carcinoma Localized | Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C0392752
UMLS CUI [3]
C0851140
presence of active uncontrolled infection.
Description

Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
known human immunodeficiency virus (hiv) infection.
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
any medical condition that may interfere with protocol evaluation or oral medication intake.
Description

Medical condition Interferes with Protocol Evaluation | Medical condition Interferes with Oral medication Intake

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C1261322
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0175795
UMLS CUI [2,4]
C1512806
prior chemotherapy other than hydroxyurea.
Description

Chemotherapy | hydroxyurea

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0020402
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Similar models

Eligibility Leukemia, Acute Myeloid NCT00687323

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute Myelocytic Leukemia Subtype Any | Acute Promyelocytic Leukemia Excluded | MYELODYSPLASTIC SYNDROME High risk | Blasts Bone marrow Percentage
Item
confirmed diagnosis of acute myeloid leukemia (aml), any subtype except acute promyelocytic leukemia (apl), by the world health organization (who) criteria, or high risk mds with blasts between 10 and 20% in the bone marrow.
boolean
C0023467 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0023487 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C3463824 (UMLS CUI [3,1])
C0332167 (UMLS CUI [3,2])
C1982687 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
Chemotherapy Absent AML | hydroxyurea
Item
no prior aml chemotherapy except hydroxyurea.
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,3])
C0020402 (UMLS CUI [2])
Leukemic Blast Count | Hydroxyurea Cytoreductive effect
Item
leukemic blast count <30x10^9/l at the start of therapy. prior cytoreduction with hydroxyurea (maximum 14 days) is permitted.
boolean
C2697913 (UMLS CUI [1])
C0020402 (UMLS CUI [2,1])
C0864494 (UMLS CUI [2,2])
Induction procedure intense Unfavorable | Risk Cytogenetic | Chromosome Deletion Complete | Chromosome Deletion Partial | Chromosome Aberrations | inv(3) Abnormality | Chromosome 11q23 Abnormality | secondary acute myeloid leukemia | Hematological Disease | Comorbidity Excludes Induction procedure | Induction procedure Refused
Item
participant is not a candidate for aggressive induction based on at least one of the following: adverse-risk cytogenetics (complete or partial deletion of 5 or 7, complex [>3] cytogenetic abnormalities, inv3, 11q23 abnormalities); secondary aml (antecedent hematologic disorder or therapy-related aml); comorbid medical illnesses precluding standard induction therapy; participant's refusal of standard induction therapy.
boolean
C0857127 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0035647 (UMLS CUI [2,1])
C0010802 (UMLS CUI [2,2])
C0008628 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0008628 (UMLS CUI [4,1])
C0728938 (UMLS CUI [4,2])
C0008625 (UMLS CUI [5])
C3829508 (UMLS CUI [6,1])
C1704258 (UMLS CUI [6,2])
C0796367 (UMLS CUI [7,1])
C1704258 (UMLS CUI [7,2])
C0280449 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0009488 (UMLS CUI [10,1])
C0332196 (UMLS CUI [10,2])
C0857127 (UMLS CUI [10,3])
C0857127 (UMLS CUI [11,1])
C1705116 (UMLS CUI [11,2])
MGMT expression low Western Blotting | beta-Actin | MGMT expression weak
Item
confirmed low mgmt expression (mgmt: beta-actin ≤0.2), as evaluated by western blot, or weak mgmt expression defined as > 0.2 and ≤2.5 if promoter is methylated, upon sponsor approval.
boolean
C0069197 (UMLS CUI [1,1])
C1171362 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C0005863 (UMLS CUI [1,4])
C0005186 (UMLS CUI [2])
C0069197 (UMLS CUI [3,1])
C1171362 (UMLS CUI [3,2])
C1762617 (UMLS CUI [3,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
Fertility Contraceptive methods
Item
use of medically approved contraception in fertile males and females.
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
negative urine or serum pregnancy test for women of childbearing potential (72 hours prior to baseline).
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Serum bilirubin increased | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
serum bilirubin >2 times the upper limit of normal (uln), or serum aspartate aminotransferase/ alanine aminotransferase >5 times uln.
boolean
C0859062 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Creatinine measurement, serum
Item
serum creatinine >200 umol/l.
boolean
C0201976 (UMLS CUI [1])
Malignant Neoplasms | Skin carcinoma Localized | Carcinoma in situ of uterine cervix
Item
history of other malignancies within 1 year prior to study entry, with the exception of localized nonmelanomatous skin cancer or cervical cancer in situ.
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C0392752 (UMLS CUI [2,2])
C0851140 (UMLS CUI [3])
Communicable Disease Uncontrolled
Item
presence of active uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
HIV Infection
Item
known human immunodeficiency virus (hiv) infection.
boolean
C0019693 (UMLS CUI [1])
Medical condition Interferes with Protocol Evaluation | Medical condition Interferes with Oral medication Intake
Item
any medical condition that may interfere with protocol evaluation or oral medication intake.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
C1512806 (UMLS CUI [2,4])
Chemotherapy | hydroxyurea
Item
prior chemotherapy other than hydroxyurea.
boolean
C0392920 (UMLS CUI [1])
C0020402 (UMLS CUI [2])
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