ID

11800

Description

Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1F7A6F51-F1C3-120A-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1F7A6F51-F1C3-120A-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

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Creative Commons BY-NC 3.0 Legacy
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Enrollment AIDS related NHL AMC-047 NCT00389818

English

It is the responsibility of the institutional PI and CRA to review ALL of the eligibility criteria in the protocol

1 forms  
Header Module
Description

Header Module

Principal Investigator
Description

PrincipalInvestigatorName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C19924
UMLS 2011AA ObjectClass
C1521895
Projected Start Date of Treatment
Description

TreatmentProjectedBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25631
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Inclusion/exclusion Criteria
Description

Inclusion/exclusion Criteria

Inclusion Criteria
Description

AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria047Type

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

AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria047Type

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
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
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
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

It is the responsibility of the institutional PI and CRA to review ALL of the eligibility criteria in the protocol

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
PrincipalInvestigatorName
Item
Principal Investigator
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19924 (NCI Thesaurus ObjectClass)
C1521895 (UMLS 2011AA ObjectClass)
TreatmentProjectedBeginDate
Item
Projected Start Date of Treatment
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass-2)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
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
If The Subject Is A Male Of Child Fathering Potential, Does He Agree To Practice Adequate Birth Control While Receiving Treatment And For Six Months After Treatment Is Discontinued (If the subject is a male of child fathering potential, does he agree to practice adequate birth control while receiving treatment and for six months after treatment is discontinued)
CL Item
Date Informed Consent Obtained (Date informed consent obtained)
CL Item
Do The Subject's Granulocytes (anc) Measure >= 1000 Mm^3 And Platelets >= 75,000 Dl (unless These Parameters Are Abnormal Secondary To Lymphomatous Involvement Of Bone Marrow, Or Due To Hiv-related Thrombocytopenia) (Do the subject's granulocytes (ANC) measure >= 1000 mm^3 and platelets >= 75,000 dL (unless these parameters are abnormal secondary to lymphomatous involvement of bone marrow, or due to HIV-related thrombocytopenia))
CL Item
Does The Patient Have The Ability And Willingness To Give Informed Consent? (Does the patient have the ability and willingness to give informed consent?)
CL Item
Does The Subject Have Documented Hiv Infection (documentation May Be Serologic [elisa, Western Blot], Culture, Or Quantitative Pcr Or Bdna Assays. Prior Documentation Of Hiv Seropositivity Is Acceptable) (Does the subject have documented HIV infection (Documentation may be serologic [ELISA, western blot], culture, or quantitative PCR or bDNA assays. Prior documentation of HIV seropositivity is acceptable))
CL Item
Does The Subject Have Either Measurable Or Non-measurable Tumor Parameter(s) Non-measurable Tumor Parameters Are Defined As Not Having Bidimensional Measurements But Can Be Followed For Response By Other Diagnostic Tests (Does the subject have either measurable or non-measurable tumor parameter(s) Non-measurable tumor parameters are defined as not having bidimensional measurements but can be followed for response by other diagnostic tests)
CL Item
Does The Subject Have Previously Untreated, Histologically Or Cytologically Documented B-cell Non-hodgkin's Lymphoma (Does the subject have previously untreated, histologically or cytologically documented B-cell non-Hodgkin's lymphoma)
CL Item
Does The Subject's Bilirubin Measure <= 2.0 Mg/dl (unless Elevated Secondary To Lymphomatous Involvement Of Liver Or Biliary System, Or Due To Other Hiv Medications [e.g., Indinavir Or Atazanavir]) (Does the subject's bilirubin measure <= 2.0 mg/dL (unless elevated secondary to lymphomatous involvement of liver or biliary system, or due to other HIV medications [e.g., indinavir or atazanavir]))
CL Item
Does The Subject's Creatinine Measure <= 2.0 Mg/dl Or Is Creatinine Clearance >= 60 Ml/min (unless Secondary To Renal Involvement By Lymphoma) (Does the subject's creatinine measure <= 2.0 mg/dL or is creatinine clearance >= 60 mL/min (unless secondary to renal involvement by lymphoma))
CL Item
If The Subject Is Female Capable Of Childbearing, Does She Agree To Practice Adequate Birth Control To Prevent Pregnancy While Receiving Treatment And For Six Months After Treatment Is Discontinued (If the subject is female capable of childbearing, does she agree to practice adequate birth control to prevent pregnancy while receiving treatment and for six months after treatment is discontinued)
CL Item
If The Subject Is Female, Has She Had A Negative Pregnancy Test Within 72 Hours Prior To Study Entry (If the subject is female, has she had a negative pregnancy test within 72 hours prior to study entry)
CL Item
Is The Disease One Of The Following Histologies: Follicular Large-cell (grade 3), Dlbcl, Immunoblastic, Plasmablastic, Or Primary Effusion Lymphoma (Is the disease one of the following histologies: follicular large-cell (Grade 3), DLBCL, immunoblastic, plasmablastic, or primary effusion lymphoma)
CL Item
Is The Subject Receiving Concurrent Effective Haart (with Any Licensed Agents, Or Any Agent Available On An Expanded Access Program) (Is the subject receiving concurrent effective HAART (with any licensed agents, or any agent available on an expanded access program))
CL Item
Is The Subject's Left Ventricular Ejection Fraction (lvef) At Or Above The Lower Institutional Limits Of Normal, As Assessed By Muga Scan Or Echocardiogram, Obtained Within The 6 Weeks Prior To Registration (Is the subject's left ventricular ejection fraction (LVEF) at or above the lower institutional limits of normal, as assessed by MUGA scan or echocardiogram, obtained within the 6 weeks prior to registration)
CL Item
Is The Subject's Lymphoma Cd20-positive (Is the subject's lymphoma CD20-positive)
CL Item
Patient's Age (in Years) (Patient's age (in years))
CL Item
Karnofsky Performance Status (must Be > 50%) (Karnofsky Performance Status (must be > 50%))
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
Is The Subject Already Receiving Erythropoietin Or G-csf For Treatment Of Hiv-related Cytopenia If Yes, Will Growth Factors Be Discontinued At Least 24 Hours Prior To Chemotherapy (Is the subject already receiving erythropoietin or G-CSF for treatment of HIV-related cytopenia If yes, will growth factors be discontinued at least 24 hours prior to chemotherapy)
CL Item
Does The Subject Have A History Of Cytotoxic Chemotherapy Or Radiotherapy For This Lymphoma (Does the subject have a history of cytotoxic chemotherapy or radiotherapy for this lymphoma)
CL Item
Does The Subject Have A Second Active Tumor, Other Than Non-melanomatous Skin Cancer, Carcinoma In Situ Of The Cervix Or Kaposi's Sarcoma That Does Not Require Systemic Therapy (Does the subject have a second active tumor, other than non-melanomatous skin cancer, carcinoma in situ of the cervix or Kaposi's sarcoma that does not require systemic therapy)
CL Item
Does The Subject Have A Serious, Ongoing, Non-malignant Disease Or Infection, Which, In The Opinion Of The Investigator And/or Sponsor, Would Compromise Protocol Objectives (Does the subject have a serious, ongoing, non-malignant disease or infection, which, in the opinion of the Investigator and/or Sponsor, would compromise protocol objectives)
CL Item
Does The Subject Have An Acute, Intercurrent Infection (excluding Mycobacterium Avium) That May Interfere With Planned Protocol Treatment (Does the subject have an acute, intercurrent infection (excluding Mycobacterium avium) that may interfere with planned protocol treatment)
CL Item
Does The Subject Have History Of Cutaneous Or Mucocutaneous Reactions Or Diseases, Due To Any Cause, Severe Enough To Cause Hospitalization Or An Inability To Eat Or Drink For >= 2 Days (Does the subject have history of cutaneous or mucocutaneous reactions or diseases, due to any cause, severe enough to cause hospitalization or an inability to eat or drink for >= 2 days)
CL Item
Does The Subject Have Inadequate Pulmonary Function (i.e., Shortness Of Breath At Rest, With Arterial Po\2 < 70 Or Pulse Oximeter-derived O\2 Saturation < 94% On Room Air [unless Due To Lymphomatous Involvement Of The Lungs]) (Does the subject have inadequate pulmonary function (i.e., shortness of breath at rest, with arterial PO\2 < 70 or pulse oximeter-derived O\2 saturation < 94% on room air [unless due to lymphomatous involvement of the lungs]))
CL Item
Does The Subject Have Leptomeningeal Disease (positive Csf For Lymphoma) Or A Presence Of Metastatic Disease Of The Brain In Terms Of Any Mass Lesion (Does the subject have leptomeningeal disease (positive CSF for lymphoma) or a presence of metastatic disease of the brain in terms of any mass lesion)
CL Item
Does The Subject Have Primary Cns Lymphoma (this Includes Parenchymal Brain Or Spinal Chord Lymphoma) (Does the subject have primary CNS lymphoma (this includes parenchymal brain or spinal chord lymphoma))
CL Item
Has The Subject Had A Myocardial Infarction (mi) Within The 6 Months Prior To Study Entry, New York Heart Association (nyha) Class Ii Or Greater Heart Failure, Uncontrolled Angina, Severe Uncontrolled Ventricular Arrhythmias, Clinically Significant (Has the subject had a myocardial infarction (MI) within the 6 months prior to study entry, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant)
CL Item
Has The Subject Had Any Major Surgery (excluding Diagnostic Surgery) Within The 4 Weeks Prior To Study Entry (Has the subject had any major surgery (excluding diagnostic surgery) within the 4 weeks prior to study entry)
CL Item
Has The Subject Received Rituximab Therapy Within The 12 Months Prior To Study Entry (Has the subject received rituximab therapy within the 12 months prior to study entry)
CL Item
If The Patient Is A Female, Is She Pregnant Or Nursing? (If the patient is a female, is she pregnant or nursing?)
CL Item
In The Opinion Of The Principal Investigator, Is The Subject Unable To Comply With The Requirements Of The Protocol, Or Unable To Provide Adequate Informed Consent (In the opinion of the Principal Investigator, is the subject unable to comply with the requirements of the protocol, or unable to provide adequate informed consent)
CL Item
Is The Subject Receiving Zidovudine As Part Of The Harrt Regimen (Is the subject receiving zidovudine as part of the HARRT regimen)
CL Item
Is The Subject's Expected Survival < 2 Months (Is the subject's expected survival < 2 months)
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])
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])
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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