ID

13167

Description

Phase I/II Study of 5-Azacytidine With Ara-C in Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT00569010

Link

https://clinicaltrials.gov/show/NCT00569010

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 NCT00569010

English

Eligibility Acute Myelogenous Leukemia NCT00569010

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have histologically confirmed acute myeloid leukemia (aml) or high risk and previously treated myelodysplastic syndrome (mds).
Description

AML or MDS

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
2. patients with (1) refractory disease or (2) first relapse within 6 months of therapy or (3) 2nd or more of relapse of acute myelogenous leukemia (aml) or high risk myelodysplastic syndrome mds will be considered for the study.
Description

refractory disease or relapse

Data type

boolean

Alias
UMLS CUI [1]
C0277556
3. patients must have been off chemotherapy for 4 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
4. age >=18 years. deoxyribonucleic acid (dna) methylation plays a significant role in development, and the effects of azacitidine in children are not well described.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. patients must have normal organ as defined: total bilirubin <2 mg, aspartate aminotransferase (ast)/alanine aminotransferase (alt) <2.5 x institutional upper limit of normal, creatinine <2 mg
Description

normal organ function

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0364051
UMLS CUI [3]
C0201976
6. ability to understand and the willingness to sign a written informed consent document.
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
7. women of child bearing potential must have a negative serum pregnancy test prior to azacitidine treatment.
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
8. women of child bearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacytidine.
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
9. eastern cooperative oncology group (ecog) performance status 0-2.
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier, unless there is evidence of rapidly progressive disease. patients may have received hydroxyurea prior to entering the study.
Description

chemotherapy or radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
2. patients may not be receiving any other investigational agents for their leukemias.
Description

investigational agent

Data type

boolean

Alias
UMLS CUI [1]
C1875319
3. patients with active brain or meningeal disease should be excluded.
Description

cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
4. known or suspected hypersensitivity to azacitidine or mannitol
Description

hypersensitivity to azacitidine or mannitol

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004475
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0024730
5. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
Description

illness that would limit compliance with study requirements

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
6. pregnant women are excluded from this study because azacitidine is a deoxyribonucleic acid (dna) methyltransferase inhibitor which has teratogenic or abortifacient effects. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with azacitidine, breastfeeding should be discontinued if the mother is treated with azacitidine.
Description

pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Acute Myelogenous Leukemia NCT00569010

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML or MDS
Item
1. patients must have histologically confirmed acute myeloid leukemia (aml) or high risk and previously treated myelodysplastic syndrome (mds).
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
refractory disease or relapse
Item
2. patients with (1) refractory disease or (2) first relapse within 6 months of therapy or (3) 2nd or more of relapse of acute myelogenous leukemia (aml) or high risk myelodysplastic syndrome mds will be considered for the study.
boolean
C0277556 (UMLS CUI [1])
chemotherapy
Item
3. patients must have been off chemotherapy for 4 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
boolean
C0392920 (UMLS CUI [1])
age
Item
4. age >=18 years. deoxyribonucleic acid (dna) methylation plays a significant role in development, and the effects of azacitidine in children are not well described.
boolean
C0001779 (UMLS CUI [1])
normal organ function
Item
5. patients must have normal organ as defined: total bilirubin <2 mg, aspartate aminotransferase (ast)/alanine aminotransferase (alt) <2.5 x institutional upper limit of normal, creatinine <2 mg
boolean
C1278039 (UMLS CUI [1])
C0364051 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
written informed consent
Item
6. ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
pregnancy
Item
7. women of child bearing potential must have a negative serum pregnancy test prior to azacitidine treatment.
boolean
C0032961 (UMLS CUI [1])
contraception
Item
8. women of child bearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacytidine.
boolean
C0700589 (UMLS CUI [1])
ecog performance status
Item
9. eastern cooperative oncology group (ecog) performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
chemotherapy or radiotherapy
Item
1. patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier, unless there is evidence of rapidly progressive disease. patients may have received hydroxyurea prior to entering the study.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
investigational agent
Item
2. patients may not be receiving any other investigational agents for their leukemias.
boolean
C1875319 (UMLS CUI [1])
cns leukemia
Item
3. patients with active brain or meningeal disease should be excluded.
boolean
C1332884 (UMLS CUI [1])
hypersensitivity to azacitidine or mannitol
Item
4. known or suspected hypersensitivity to azacitidine or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C0004475 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0024730 (UMLS CUI [2,2])
illness that would limit compliance with study requirements
Item
5. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
pregnancy or lactation
Item
6. pregnant women are excluded from this study because azacitidine is a deoxyribonucleic acid (dna) methyltransferase inhibitor which has teratogenic or abortifacient effects. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with azacitidine, breastfeeding should be discontinued if the mother is treated with azacitidine.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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