ID

11801

Description

AMC-048 ENR (Enrollment) NCT00392834 Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=32E18FA2-33FA-4AF2-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=32E18FA2-33FA-4AF2-E044-0003BA3F9857

Keywords

Versions (4)
  1. 9/19/12 9/19/12 -
  2. 5/28/15 5/28/15 -
  3. 6/3/15 6/3/15 -
  4. 8/4/15 8/4/15 - Martin Dugas
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August 4, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Enrollment HIV associated Burkitt Lymphoma AMC-048 NCT00392834

English

No Instruction available.

1 forms  
  1. StudyEvent: AMC-048 ENR (Enrollment)
    1. No Instruction available.
Header Module
Description

Header Module

Principal Investigator
Description

Principal Investigator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C19924
UMLS CUI [1]
C1521895
Projected Start Date of Treatment
Description

Projected Start Date of Treatment

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25631
NCI Thesaurus Property
C25431
NCI Thesaurus Property-2
C25275
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI [1]
C3173309
Inclusion/exclusion Criteria
Description

Inclusion/exclusion Criteria

Inclusion Criteria
Description

AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria048Type

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C19707
UMLS 2011AA ObjectClass-2
C1515830
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property-2
C25532
UMLS 2011AA Property-2
C1512693
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Exclusion Criteria
Description

Exclusion Criteria

Exclusion Criteria
Description

AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria048Type

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C19707
UMLS 2011AA ObjectClass-2
C1515830
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property-2
C25370
UMLS 2011AA Property-2
C0680251
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Informed Consent Date
Description

Informed Consent Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
NCI Thesaurus Property
C25679
UMLS CUI [1]
C2985782
Karnofsky Performance Status
Description

Karnofsky Performance Status

Data type

integer

Measurement units
  • %
Alias
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C20641
NCI Thesaurus ValueDomain
C25338
UMLS CUI [1]
C0206065
Age
Description

Age

Data type

integer

Measurement units
  • years
Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain
C29848
NCI Thesaurus ValueDomain-2
C25463
NCI Thesaurus Property
C25150
UMLS CUI [1]
C0001779
years
Disease Risk
Description

Disease Risk

Modified Ann Arbor Stage
Description

LymphomaAnnArborLymphomaStagingSystemClassificationStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3208
NCI Thesaurus ValueDomain
C16899
NCI Thesaurus Property
C25161
UMLS CUI [1]
C0432516
Does the participant have normal LDH
Description

LaboratoryProcedureLactateDehydrogenaseResultInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C25184
UMLS 2011AA Property-2
C0022917
Does the participant have a single focus of disease that measures <10 cm
Description

SingleMalignantNeoplasmSizeIndicator

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C48440
UMLS 2011AA ObjectClass-2
C0205171
NCI Thesaurus Property
C25681
UMLS 2011AA Property
C0456389
Does the participant have intra-abdominal disease only and total resection
Description

CompleteResectedAbdominalCavityDiseaseAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25250
UMLS 2011AA ObjectClass
C0205197
NCI Thesaurus ObjectClass-2
C12664
UMLS 2011AA ObjectClass-2
C0230168
NCI Thesaurus ObjectClass-3
C2991
UMLS 2011AA ObjectClass-3
C0012634
NCI Thesaurus ObjectClass-4
C25654
UMLS 2011AA ObjectClass-4
C1521996
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Comments
Description

Comments

Comments
Description

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: AMC-048 ENR (Enrollment)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Principal Investigator
Item
Principal Investigator
text
C25191 (NCI Thesaurus ValueDomain)
C25364 (NCI Thesaurus Property)
C19924 (NCI Thesaurus ObjectClass)
C1521895 (UMLS CUI [1])
Treatment Begin Date
Item
Projected Start Date of Treatment
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass-2)
C25431 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C3173309 (UMLS CUI [1])
Item Group
Inclusion/exclusion Criteria
Item
Inclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C1515830 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property-2)
C1512693 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.1
Code List
Inclusion Criteria
CL Item
Date Informed Consent Obtained (Date informed consent obtained)
CL Item
Does The Participant Have A Direct Bilirubin Level Of <=2.0 Mg/dl (Does the participant have a direct bilirubin level of <=2.0 mg/dL)
CL Item
Does The Participant Have A Histologic Diagnosis Of Burkitt's Lymphoma (bl) Or Atypical Burkitt's As Per Who Criteria (Does the participant have a histologic diagnosis of Burkitt's lymphoma (BL) or atypical Burkitt's as per WHO criteria)
CL Item
Does The Participant Have A Serum Creatinine <=1.5 Mg/dl (Does the participant have a serum creatinine <=1.5 mg/dL)
CL Item
Does The Participant Have Anc >=1000/ul And Platelets >=50,000ul (unless Disease-related) (Does the participant have ANC >=1000/uL and platelets >=50,000uL (unless disease-related))
CL Item
Does The Participant Have Ast (sgot) And Alt (sgpt) <=3 X The Upper Limit Of Normal (Does the participant have AST (SGOT) and ALT (SGPT) <=3 x the upper limit of normal)
CL Item
Does The Participant Have Measurable Or Nonmeasurable Tumor Parameter(s) (Does the participant have measurable or non-measurable tumor parameter(s))
CL Item
Does The Participant Have Normal Baseline Cardiac Function Based Upon Echocardiogram Or Multigated Acquisition (muga) Blood Pool Scan With An Ejection Fraction >=50% (Does the participant have normal baseline cardiac function based upon echocardiogram or multigated acquisition (MUGA) blood pool scan with an ejection fraction >=50%)
CL Item
If The Elevated Bilirubin Is Felt To Be Secondary To Antiretroviral Therapy, Is The Participant's Total Bilirubin <=3.5 Mg/dl Provided That The Direct Bilirubin Is Normal (If the elevated bilirubin is felt to be secondary to antiretroviral therapy, is the participant's total bilirubin <=3.5 mg/dL provided that the direct bilirubin is normal)
CL Item
If The Participant Is Female Who Is Premenopausal, Did She Have A Negative Pregnancy Test (If the participant is female who is premenopausal, did she have a negative pregnancy test)
CL Item
If The Participant Is Female, Is She Of Childbearing Age And Using An Acceptable Form Of Birth Control (If the participant is female, is she of childbearing age and using an acceptable form of birth control)
CL Item
If The Participant's Creatinine Is >1.5 Mg/dl, Is The Creatinine Clearance >=60 Ml/minute (If the participant's creatinine is >1.5 mg/dL, is the creatinine clearance >=60 mL/minute)
CL Item
Is The Participant (or Their Guardian) Capable Of Providing Informed Consent (Is the participant (or their guardian) capable of providing informed consent)
CL Item
Is The Participant Hiv Positive Documented By Enzyme-linked Immunosorbent Assay [elisa] And Western Blot, Or Measurable Hiv Viral Load (Is the participant HIV positive documented by enzyme-linked immunosorbent assay [ELISA] and Western Blot, or measurable HIV viral load)
CL Item
Karnofsky Performance Status (must Be >30%) (Karnofsky performance status (must be >30%))
CL Item
Participant's Age (in Years) (Participant's age (in years))
Item Group
Exclusion Criteria
Item
Exclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C1515830 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property-2)
C0680251 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.2
Code List
Exclusion Criteria
CL Item
Does The Participant Have A History Of Any Malignancy For Which The Disease-free Interval Is <5 Years, Excluding Curatively Treated Cutaneous Basal Cell Or Squamous Cell Carcinoma And Carcinoma In Situ Of The Cervix Or Cutaneous Ks (Does the participant have a history of any malignancy for which the disease-free interval is <5 years, excluding curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma in situ of the cervix or cutaneous KS)
CL Item
Does The Participant Have Any Medical Illness Unrelated To Nhl, Which In The Opinion Of The Attending Physician And Principal Investigator (pi), Will Preclude Administration Of Chemotherapy Safely (Does the participant have any medical illness unrelated to NHL, which in the opinion of the attending physician and Principal Investigator (PI), will preclude administration of chemotherapy safely)
CL Item
Has The Participant Received Previous Therapy For Bl Or Atypical Bl Other Than Seven Consecutive Days Of Steroids (Has the participant received previous therapy for BL or atypical BL other than seven consecutive days of steroids)
CL Item
If The Participant Is Female, Is She Pregnant Or Breast-feeding (If the participant is female, is she pregnant or breast-feeding)
CL Item
If Yes, Will The Growth Factors Be Discontinued At Least 24 Hours Prior To Chemotherapy (If yes, will the growth factors be discontinued at least 24 hours prior to chemotherapy)
CL Item
Is The Participant Already Receiving Erythropoietin Or G-csf For Treatment Of Hiv-related Cytopenia (Is the participant already receiving erythropoietin or G-CSF for treatment of HIV-related cytopenia)
Informed Consent Date
Item
Informed Consent Date
date
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C25679 (NCI Thesaurus Property)
C2985782 (UMLS CUI [1])
Item
Karnofsky Performance Status
integer
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0206065 (UMLS CUI [1])
Karnofsky Performance Status
Code List
Karnofsky Performance Status
CL Item
Dead (0)
CL Item
Moribund, Fatal Processes Progressing Rapidly (10)
CL Item
Normal, No Complaints, No Evidence Of Disease (100)
CL Item
Very Sick, Hospitalization Indicated. Death Not Imminent (20)
CL Item
Severely Disabled, Hospitalization Indicated. Death Not Imminent (30)
CL Item
Disabled, Requires Special Care And Assistance (40)
CL Item
Requires Considerable Assistance And Frequent Medical Care (50)
CL Item
Requires Occasional Assistance, But Is Able To Care For Most Of His/her Needs (60)
CL Item
Cares For Self, Unable To Carry On Normal Activity Or To Do Active Work (70)
CL Item
Normal Activity With Effort; Some Signs Or Symptoms Of Disease (80)
CL Item
Able To Carry On Normal Activity; Minor Signs Or Symptoms Of Disease (90)
Age
Item
Age
integer
C16960 (NCI Thesaurus ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS CUI [1])
Item Group
Disease Risk
Item
Modified Ann Arbor Stage
text
C3208 (NCI Thesaurus ObjectClass)
C16899 (NCI Thesaurus ValueDomain)
C25161 (NCI Thesaurus Property)
C0432516 (UMLS CUI [1])
CL.3
Code List
Modified Ann Arbor Stage
CL Item
I (I)
CL Item
Ie (IE)
CL Item
Ii (II)
CL Item
Iie (IIE)
CL Item
Iii (III)
CL Item
Iiie (IIIE)
CL Item
Iiie+s (IIIE+S)
CL Item
Iiis (IIIS)
CL Item
Iv (IV)
LaboratoryProcedureLactateDehydrogenaseResultInd-2
Item
Does the participant have normal LDH
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25184 (NCI Thesaurus Property-2)
C0022917 (UMLS 2011AA Property-2)
SingleMalignantNeoplasmSizeIndicator
Item
Does the participant have a single focus of disease that measures <10 cm
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass-2)
C0205171 (UMLS 2011AA ObjectClass-2)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)
CompleteResectedAbdominalCavityDiseaseAssessmentInd-2
Item
Does the participant have intra-abdominal disease only and total resection
boolean
C25250 (NCI Thesaurus ObjectClass)
C0205197 (UMLS 2011AA ObjectClass)
C12664 (NCI Thesaurus ObjectClass-2)
C0230168 (UMLS 2011AA ObjectClass-2)
C2991 (NCI Thesaurus ObjectClass-3)
C0012634 (UMLS 2011AA ObjectClass-3)
C25654 (NCI Thesaurus ObjectClass-4)
C1521996 (UMLS 2011AA ObjectClass-4)
C25367 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Comments
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
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