ID

14498

Description

Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00112853

Link

https://clinicaltrials.gov/show/NCT00112853

Keywords

  1. 4/18/16 4/18/16 -
Uploaded on

April 18, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT00112853

Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT00112853

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults age with established, pathologically confirmed diagnoses of newly diagnosed aml, including de novo and secondary amls but excluding newly diagnosed acute progranulocytic leukemia (apl, m3), will be considered eligible for study
Description

AML

Data type

boolean

Alias
UMLS CUI [1]
C0023467
ecog performance status 0-2
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1632812
patient must be able to give informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
serum creatinine =< 2.0 mg/dl
Description

serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
sgot and sgpt =< 5 x upper limit normal (uln)
Description

sgot and sgpt

Data type

boolean

Alias
UMLS CUI [1]
C1860080
bilirubin =< 2 mg/dl
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
newly diagnosed aml, subtypes m0,1,2,4-7 but excluding m3 (apl), including myelodysplasia (mds)-related aml (mds/aml) and treatment-related aml
Description

newly diagnosed aml and hmatopoetic myelodysplasia

Data type

boolean

Alias
UMLS CUI [1]
C2713368
patients who have received hydroxyurea alone or have received non-cytotoxic therapies previously for mds (e.g., thalidomide, interferon, cytokines, 5-azacytidine) will be eligible for this trial
Description

hydroxyurea

Data type

boolean

Alias
UMLS CUI [1]
C0020402
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any previous treatment with r115777 or vp-16
Description

R115777 or VP-16

Data type

boolean

Alias
UMLS CUI [1]
C0393031
UMLS CUI [2]
C0733688
patients receiving concomitant chemotherapy, radiation therapy or immunotherapy
Description

Chemotherapy, immunotherapy, radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C3665472
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
hyperleukocytosis with >= 30,000 blasts/ul or rapidly rising blast count with projected doubling time of =< 2 days
Description

Hyperleukocytic syndrome

Data type

boolean

Alias
UMLS CUI [1]
C3805210
acute progranulocytic leukemia (apl,m3)
Description

adult acute promyelocytic leukemia (M3)

Data type

boolean

Alias
UMLS CUI [1]
C0279625
active cns leukemia
Description

cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
Description

Infection

Data type

boolean

Alias
UMLS CUI [1]
C3714514
presence of other life-threatening illness
Description

Life threatening illness

Data type

boolean

Alias
UMLS CUI [1]
C3846017
patients with mental deficits and/or psychiatric history that preclude them from giving informed consent or from following protocol
Description

Cognition Disorders or Psychiatric History

Data type

boolean

Alias
UMLS CUI [1]
C0009241
UMLS CUI [2]
C0748059
patients on enzyme-inducing anti-convulsants (e.g., phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine); patients may be changed to non-enzyme inducing anti-convulsants and stabilized before starting study treatment
Description

Anticonvulsants

Data type

boolean

Alias
UMLS CUI [1]
C0003286

Similar models

Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT00112853

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
adults age with established, pathologically confirmed diagnoses of newly diagnosed aml, including de novo and secondary amls but excluding newly diagnosed acute progranulocytic leukemia (apl, m3), will be considered eligible for study
boolean
C0023467 (UMLS CUI [1])
ecog performance status
Item
ecog performance status 0-2
boolean
C1632812 (UMLS CUI [1])
informed consent
Item
patient must be able to give informed consent
boolean
C0021430 (UMLS CUI [1])
serum creatinine
Item
serum creatinine =< 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
sgot and sgpt
Item
sgot and sgpt =< 5 x upper limit normal (uln)
boolean
C1860080 (UMLS CUI [1])
bilirubin
Item
bilirubin =< 2 mg/dl
boolean
C1278039 (UMLS CUI [1])
newly diagnosed aml and hmatopoetic myelodysplasia
Item
newly diagnosed aml, subtypes m0,1,2,4-7 but excluding m3 (apl), including myelodysplasia (mds)-related aml (mds/aml) and treatment-related aml
boolean
C2713368 (UMLS CUI [1])
hydroxyurea
Item
patients who have received hydroxyurea alone or have received non-cytotoxic therapies previously for mds (e.g., thalidomide, interferon, cytokines, 5-azacytidine) will be eligible for this trial
boolean
C0020402 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
R115777 or VP-16
Item
any previous treatment with r115777 or vp-16
boolean
C0393031 (UMLS CUI [1])
C0733688 (UMLS CUI [2])
Chemotherapy, immunotherapy, radiation therapy
Item
patients receiving concomitant chemotherapy, radiation therapy or immunotherapy
boolean
C3665472 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
Hyperleukocytic syndrome
Item
hyperleukocytosis with >= 30,000 blasts/ul or rapidly rising blast count with projected doubling time of =< 2 days
boolean
C3805210 (UMLS CUI [1])
adult acute promyelocytic leukemia (M3)
Item
acute progranulocytic leukemia (apl,m3)
boolean
C0279625 (UMLS CUI [1])
cns leukemia
Item
active cns leukemia
boolean
C1332884 (UMLS CUI [1])
Infection
Item
active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
boolean
C3714514 (UMLS CUI [1])
Life threatening illness
Item
presence of other life-threatening illness
boolean
C3846017 (UMLS CUI [1])
Cognition Disorders or Psychiatric History
Item
patients with mental deficits and/or psychiatric history that preclude them from giving informed consent or from following protocol
boolean
C0009241 (UMLS CUI [1])
C0748059 (UMLS CUI [2])
Anticonvulsants
Item
patients on enzyme-inducing anti-convulsants (e.g., phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine); patients may be changed to non-enzyme inducing anti-convulsants and stabilized before starting study treatment
boolean
C0003286 (UMLS CUI [1])

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