ID

30213

Description

Clofarabine, Etoposide, and Mitoxantrone for Relapsed and Refractory Acute Leukemias; ODM derived from: https://clinicaltrials.gov/show/NCT00882076

Link

https://clinicaltrials.gov/show/NCT00882076

Keywords

Versions (1)
  1. 18-05-18 18-05-18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

18 mei 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00882076

English

Eligibility Leukemia NCT00882076

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00882076
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adequate renal and hepatic function.
Description

Renal function | Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent.
Description

Comprehension Study Protocol | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
Description

Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
Description

Gender | Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0700589
lvef must be ≥ 50% within 2 weeks.
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
Description

Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Exception Specification Study Protocol

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2348235
UMLS CUI [4,3]
C2348563
use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. the patient must have recovered from all acute toxicities from any previous therapy.
Description

Investigational New Drugs | Cancer treatment | Exception Hydroxyurea | Toxicity Due to Prior Therapy | Patient recovered

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0920425
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0020402
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C1514463
UMLS CUI [5]
C1115804
have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo treatment.
Description

Comorbidity Severe | Organ dysfunction Serious | Heart Diseases | Kidney Diseases | Liver diseases | Organ system Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0349410
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0023895
UMLS CUI [6,1]
C0460002
UMLS CUI [6,2]
C0012634
patients with a systemic fungal, bacterial, viral, or other infection not controlled.
Description

Systemic mycosis | Bacterial Infection Systemic | Virus Disease Systemic | Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0553576
UMLS CUI [2,1]
C0004623
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C0042769
UMLS CUI [3,2]
C0205373
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205318
any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up or interpretation of study results.
Description

Comorbidity compromises Patient safety | Comorbidity compromises Compliance behavior | Comorbidity Interferes with Informed Consent | Comorbidity Interferes with Study Subject Participation Status | Comorbidity Interferes with Follow-up | Comorbidity Interferes with Interpretation Research results | Mental disorders compromise Patient safety | Mental disorders compromise Compliance behavior | Mental disorders Interfere with Informed Consent | Mental disorders Interfere with Study Subject Participation Status | Mental disorders Interfere with Follow-up | Mental disorders Interfere with Interpretation Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1321605
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C0009488
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C3274571
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0459471
UMLS CUI [6,4]
C0683954
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C1113679
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C2945640
UMLS CUI [8,3]
C1321605
UMLS CUI [9,1]
C0004936
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C0021430
UMLS CUI [10,1]
C0004936
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C2348568
UMLS CUI [11,1]
C0004936
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C3274571
UMLS CUI [12,1]
C0004936
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C0459471
UMLS CUI [12,4]
C0683954
have had a diagnosis of another malignancy, unless the patient has been disease free for at least 3 years following the completion of curative intent therapy with the following exceptions: patients with treated non-melanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for the study if definitive treatment for the condition has been completed. patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed. additionally, patients with prostate cancer treated with radiation therapy are also eligible for the study.
Description

Cancer Other | Exception Patient Disease Free of | Status post Completion Therapeutic procedure Curative | Exception Skin carcinoma Treated | Exception Carcinoma in Situ Treated | Exception Cervical Intraepithelial Neoplasia Treated | Exception Prostate carcinoma Organ confined | Absence Recurrent disease PSA measurement | Absence Progressive Disease PSA measurement | Initiation Hormone Therapy | Radical prostatectomy | Exception Therapeutic radiology procedure Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C0012634
UMLS CUI [2,4]
C0332296
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0205197
UMLS CUI [3,3]
C0087111
UMLS CUI [3,4]
C1276305
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0699893
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007099
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0206708
UMLS CUI [6,3]
C1522326
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0600139
UMLS CUI [7,3]
C1273595
UMLS CUI [8,1]
C0332197
UMLS CUI [8,2]
C0277556
UMLS CUI [8,3]
C0201544
UMLS CUI [9,1]
C0332197
UMLS CUI [9,2]
C1335499
UMLS CUI [9,3]
C0201544
UMLS CUI [10,1]
C1704686
UMLS CUI [10,2]
C0279025
UMLS CUI [11]
C0194810
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C1522449
UMLS CUI [12,3]
C0600139
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Similar models

Eligibility Leukemia NCT00882076

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00882076
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Renal function | Liver function
Item
adequate renal and hepatic function.
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Comprehension Study Protocol | Informed Consent
Item
capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Childbearing Potential Serum pregnancy test negative
Item
female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Gender | Contraceptive methods
Item
male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
boolean
C0079399 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Left ventricular ejection fraction
Item
lvef must be ≥ 50% within 2 weeks.
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Exception Specification Study Protocol
Item
current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C2348235 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
Investigational New Drugs | Cancer treatment | Exception Hydroxyurea | Toxicity Due to Prior Therapy | Patient recovered
Item
use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. the patient must have recovered from all acute toxicities from any previous therapy.
boolean
C0013230 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0020402 (UMLS CUI [3,2])
C0600688 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C1514463 (UMLS CUI [4,3])
C1115804 (UMLS CUI [5])
Comorbidity Severe | Organ dysfunction Serious | Heart Diseases | Kidney Diseases | Liver diseases | Organ system Disease
Item
have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo treatment.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0349410 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0460002 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
Systemic mycosis | Bacterial Infection Systemic | Virus Disease Systemic | Communicable Disease Uncontrolled
Item
patients with a systemic fungal, bacterial, viral, or other infection not controlled.
boolean
C0553576 (UMLS CUI [1])
C0004623 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0042769 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Comorbidity compromises Patient safety | Comorbidity compromises Compliance behavior | Comorbidity Interferes with Informed Consent | Comorbidity Interferes with Study Subject Participation Status | Comorbidity Interferes with Follow-up | Comorbidity Interferes with Interpretation Research results | Mental disorders compromise Patient safety | Mental disorders compromise Compliance behavior | Mental disorders Interfere with Informed Consent | Mental disorders Interfere with Study Subject Participation Status | Mental disorders Interfere with Follow-up | Mental disorders Interfere with Interpretation Research results
Item
any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up or interpretation of study results.
boolean
C0009488 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C0009488 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0009488 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C3274571 (UMLS CUI [5,3])
C0009488 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0459471 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C0004936 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C1113679 (UMLS CUI [7,3])
C0004936 (UMLS CUI [8,1])
C2945640 (UMLS CUI [8,2])
C1321605 (UMLS CUI [8,3])
C0004936 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0021430 (UMLS CUI [9,3])
C0004936 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C2348568 (UMLS CUI [10,3])
C0004936 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C3274571 (UMLS CUI [11,3])
C0004936 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0459471 (UMLS CUI [12,3])
C0683954 (UMLS CUI [12,4])
Cancer Other | Exception Patient Disease Free of | Status post Completion Therapeutic procedure Curative | Exception Skin carcinoma Treated | Exception Carcinoma in Situ Treated | Exception Cervical Intraepithelial Neoplasia Treated | Exception Prostate carcinoma Organ confined | Absence Recurrent disease PSA measurement | Absence Progressive Disease PSA measurement | Initiation Hormone Therapy | Radical prostatectomy | Exception Therapeutic radiology procedure Prostate carcinoma
Item
have had a diagnosis of another malignancy, unless the patient has been disease free for at least 3 years following the completion of curative intent therapy with the following exceptions: patients with treated non-melanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for the study if definitive treatment for the condition has been completed. patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed. additionally, patients with prostate cancer treated with radiation therapy are also eligible for the study.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
C0332296 (UMLS CUI [2,4])
C0231290 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1276305 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0699893 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0007099 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0206708 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0600139 (UMLS CUI [7,2])
C1273595 (UMLS CUI [7,3])
C0332197 (UMLS CUI [8,1])
C0277556 (UMLS CUI [8,2])
C0201544 (UMLS CUI [8,3])
C0332197 (UMLS CUI [9,1])
C1335499 (UMLS CUI [9,2])
C0201544 (UMLS CUI [9,3])
C1704686 (UMLS CUI [10,1])
C0279025 (UMLS CUI [10,2])
C0194810 (UMLS CUI [11])
C1705847 (UMLS CUI [12,1])
C1522449 (UMLS CUI [12,2])
C0600139 (UMLS CUI [12,3])
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