ID

14572

Description

Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Promyelocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01869803

Link

https://clinicaltrials.gov/show/NCT01869803

Keywords

Versions (1)
  1. 4/21/16 4/21/16 -
Uploaded on

April 21, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities NCT01869803

English

Eligibility Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities NCT01869803

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of relapsed or refractory aml and not candidate for standard consolidation treatment after daunorubicin and cytosine arabinoside or diagnosis of apl relapsed after tretinoin (atra) and arsenic trioxide therapy or apl with persisting or rising blasts, and no other comparable or satisfactory alternative therapy available (including patients not eligible for, or who have access to, investigational therapies via a clinical trial)
Description

relapsed or refractory aml

Data type

boolean

Alias
UMLS CUI [1]
C2367456
patients must have an initial diagnosis of aml, biphenotypic acute leukemia, or apl
Description

Acute biphenotypic leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023464
patients must have cluster of differentiation (cd)33 positivity of > 30%
Description

Clusters of differentiation

Data type

boolean

Alias
UMLS CUI [1]
C1955216
eastern cooperative oncology group (ecog) performance status =< 3 / karnofsky > 60%
Description

eastern cooperative oncology group

Data type

boolean

Alias
UMLS CUI [1]
C1512162
total bilirubin within normal institutional limits
Description

total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0201913
aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase [sgot])/alanine aminotransferase (alt) (serum glutamate pyruvate transaminase [sgpt]) =< 2 x institutional upper limit of normal
Description

aspartate aminotransferase

Data type

boolean

Alias
UMLS CUI [1]
C0201899
it is deemed ethical to provide an experimental drug (e.g., mylotarg) that is associated with hepatotoxicity (veno-occlusive disease [vod]) and myelosuppression
Description

experimental drug

Data type

boolean

Alias
UMLS CUI [1]
C0304229
women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to receiving mylotarg and for the duration of treatment; should a woman become pregnant or suspect she is pregnant while receiving treatment with mylotarg, she should inform her treating physician immediately
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0420837
ability to understand and the willingness to sign a written institutional review board (irb)-approved informed consent document
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients may not currently be receiving any other investigational agents for leukemia
Description

investigational agent

Data type

boolean

Alias
UMLS CUI [1]
C0013230
patients with known untreated hepatitis c
Description

hepatitis c

Data type

boolean

Alias
UMLS CUI [1]
C0019196
uncontrolled intercurrent illness including, but not limited to active liver disease, or psychiatric illness/social situations that would limit compliance with study requirements
Description

intercurrent illness

Data type

boolean

Alias
UMLS CUI [1]
C3640977
pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with mylotarg
Description

pregnant women

Data type

boolean

Alias
UMLS CUI [1]
C0032961
human immunodeficiency virus (hiv)-positive patients on combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
Description

human immunodeficiency virus

Data type

boolean

Alias
UMLS CUI [1]
C0019682
patients with a known hypersensitivity to gemtuzumab ozogamicin or its parts: recombinant humanized anti-cd33 monoclonal (hp67.6) antibody, calicheamicin derivatives or other ingredients
Description

hypersensitivity to gemtuzumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0872968
UMLS CUI [1,2]
C0020517
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Similar models

Eligibility Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities NCT01869803

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
relapsed or refractory aml
Item
diagnosis of relapsed or refractory aml and not candidate for standard consolidation treatment after daunorubicin and cytosine arabinoside or diagnosis of apl relapsed after tretinoin (atra) and arsenic trioxide therapy or apl with persisting or rising blasts, and no other comparable or satisfactory alternative therapy available (including patients not eligible for, or who have access to, investigational therapies via a clinical trial)
boolean
C2367456 (UMLS CUI [1])
Acute biphenotypic leukemia
Item
patients must have an initial diagnosis of aml, biphenotypic acute leukemia, or apl
boolean
C0023464 (UMLS CUI [1])
Clusters of differentiation
Item
patients must have cluster of differentiation (cd)33 positivity of > 30%
boolean
C1955216 (UMLS CUI [1])
eastern cooperative oncology group
Item
eastern cooperative oncology group (ecog) performance status =< 3 / karnofsky > 60%
boolean
C1512162 (UMLS CUI [1])
total bilirubin
Item
total bilirubin within normal institutional limits
boolean
C0201913 (UMLS CUI [1])
aspartate aminotransferase
Item
aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase [sgot])/alanine aminotransferase (alt) (serum glutamate pyruvate transaminase [sgpt]) =< 2 x institutional upper limit of normal
boolean
C0201899 (UMLS CUI [1])
experimental drug
Item
it is deemed ethical to provide an experimental drug (e.g., mylotarg) that is associated with hepatotoxicity (veno-occlusive disease [vod]) and myelosuppression
boolean
C0304229 (UMLS CUI [1])
contraception
Item
women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to receiving mylotarg and for the duration of treatment; should a woman become pregnant or suspect she is pregnant while receiving treatment with mylotarg, she should inform her treating physician immediately
boolean
C0420837 (UMLS CUI [1])
informed consent
Item
ability to understand and the willingness to sign a written institutional review board (irb)-approved informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
investigational agent
Item
patients may not currently be receiving any other investigational agents for leukemia
boolean
C0013230 (UMLS CUI [1])
hepatitis c
Item
patients with known untreated hepatitis c
boolean
C0019196 (UMLS CUI [1])
intercurrent illness
Item
uncontrolled intercurrent illness including, but not limited to active liver disease, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C3640977 (UMLS CUI [1])
pregnant women
Item
pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with mylotarg
boolean
C0032961 (UMLS CUI [1])
human immunodeficiency virus
Item
human immunodeficiency virus (hiv)-positive patients on combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
boolean
C0019682 (UMLS CUI [1])
hypersensitivity to gemtuzumab
Item
patients with a known hypersensitivity to gemtuzumab ozogamicin or its parts: recombinant humanized anti-cd33 monoclonal (hp67.6) antibody, calicheamicin derivatives or other ingredients
boolean
C0872968 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
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