ID

13171

Description

A Phase 2 Trial of MLN8237 in Adult Patients With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00830518

Link

https://clinicaltrials.gov/show/NCT00830518

Keywords

Versions (1)
  1. 1/21/16 1/21/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 21, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT00830518

English

Eligibility Acute Myelogenous Leukemia NCT00830518

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patients 18 years or older
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. eligible diagnoses: acute myelogenous leukemia (except apl) with > 10% bone marrow or peripheral blood blasts; failed to achieve cr or relapse after prior therapy, not candidates for potentially curative treatment. untreated patients > 60 are eligible if not candidates for standard induction. high-grade mds, defined by all the following features: ipss intermediate-2 or high risk; > 10% blasts on bone marrow examination; treatment failure from, or not candidates for, standard therapies including demethylating agents, eg azacytidine or decitabine.
Description

eligible diagnoses

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
3. eastern cooperative oncology group perf. status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. female patients: postmenopausal for at least one year surgically sterile, or if childbearing potential, agree to practice two effective methods of contraception or abstain from heterosexual intercourse.
Description

female patients

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0232920
5. male patients: practice effective barrier contraception to one month after the last dose of study drug, or abstain from heterosexual intercourse.
Description

male patients

Data type

boolean

Alias
UMLS CUI [1]
C0700589
6. voluntary written consent
Description

written consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
7. patients on hydroxyurea may be included
Description

hydroxyurea

Data type

boolean

Alias
UMLS CUI [1]
C0020402
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or lactating females
Description

pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. known human immunodeficiency virus (hiv) positive or aids-related illness
Description

HIV or aids-related illness

Data type

boolean

Alias
UMLS CUI [1]
C0019682
3. serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the protocol completion
Description

comorbidity that could interfere with the protocol completion

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
4. total bilirubin > 1.5 × the upper limit of normal (uln)
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
5. alanine aminotransferase (alt) and aspartate aminotransferase (ast) > 2.5 × the uln. ast, alt may be elevated to 5 x the uln if reasonably ascribed to underlying hematological disorder.
Description

ALT, AST

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
6. calculated creatinine clearance < 30 ml/minute
Description

creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
7. antineoplastic or radiotherapy within 14 days preceding the first dose
Description

chemotherapy or radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
8. myocardial infarction within 6 months of enrollment or current history of new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
Description

cardiac diseases

Data type

boolean

Alias
UMLS CUI [1]
C0018799
9. major surgery 14 days prior to the first dose
Description

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0543467
10. clinically uncontrolled central nervous system (cns) involvement.
Description

cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
11. inability to swallow capsules
Description

inability to swallow capsule

Data type

boolean

Alias
UMLS CUI [1]
C0006935
12. history of uncontrolled sleep apnea or conditions that result in excessive daytime sleepiness, such as chronic lung disease
Description

sleep apnea or conditions that result in excessive daytime sleepiness

Data type

boolean

Alias
UMLS CUI [1]
C0037315
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Similar models

Eligibility Acute Myelogenous Leukemia NCT00830518

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
1. male or female patients 18 years or older
boolean
C0001779 (UMLS CUI [1])
eligible diagnoses
Item
2. eligible diagnoses: acute myelogenous leukemia (except apl) with > 10% bone marrow or peripheral blood blasts; failed to achieve cr or relapse after prior therapy, not candidates for potentially curative treatment. untreated patients > 60 are eligible if not candidates for standard induction. high-grade mds, defined by all the following features: ipss intermediate-2 or high risk; > 10% blasts on bone marrow examination; treatment failure from, or not candidates for, standard therapies including demethylating agents, eg azacytidine or decitabine.
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
ECOG performance status
Item
3. eastern cooperative oncology group perf. status 0-2
boolean
C1520224 (UMLS CUI [1])
female patients
Item
4. female patients: postmenopausal for at least one year surgically sterile, or if childbearing potential, agree to practice two effective methods of contraception or abstain from heterosexual intercourse.
boolean
C0700589 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0232920 (UMLS CUI [3])
male patients
Item
5. male patients: practice effective barrier contraception to one month after the last dose of study drug, or abstain from heterosexual intercourse.
boolean
C0700589 (UMLS CUI [1])
written consent
Item
6. voluntary written consent
boolean
C0021430 (UMLS CUI [1])
hydroxyurea
Item
7. patients on hydroxyurea may be included
boolean
C0020402 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnancy or lactation
Item
1. pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV or aids-related illness
Item
2. known human immunodeficiency virus (hiv) positive or aids-related illness
boolean
C0019682 (UMLS CUI [1])
comorbidity that could interfere with the protocol completion
Item
3. serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the protocol completion
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
bilirubin
Item
4. total bilirubin > 1.5 × the upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
ALT, AST
Item
5. alanine aminotransferase (alt) and aspartate aminotransferase (ast) > 2.5 × the uln. ast, alt may be elevated to 5 x the uln if reasonably ascribed to underlying hematological disorder.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
creatinine clearance
Item
6. calculated creatinine clearance < 30 ml/minute
boolean
C0373595 (UMLS CUI [1])
chemotherapy or radiotherapy
Item
7. antineoplastic or radiotherapy within 14 days preceding the first dose
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
cardiac diseases
Item
8. myocardial infarction within 6 months of enrollment or current history of new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
boolean
C0018799 (UMLS CUI [1])
major surgery
Item
9. major surgery 14 days prior to the first dose
boolean
C0543467 (UMLS CUI [1])
cns leukemia
Item
10. clinically uncontrolled central nervous system (cns) involvement.
boolean
C1332884 (UMLS CUI [1])
inability to swallow capsule
Item
11. inability to swallow capsules
boolean
C0006935 (UMLS CUI [1])
sleep apnea or conditions that result in excessive daytime sleepiness
Item
12. history of uncontrolled sleep apnea or conditions that result in excessive daytime sleepiness, such as chronic lung disease
boolean
C0037315 (UMLS CUI [1])
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