Item
Hematopoietic Diagnosis (Mark one with an X. see Section 4.1.1 Histologically confirmed follicular lymphoma, WHO classification grade 1, 2, or 3a without histologic transformation that is stage III, IV or bulky stage II i.e., single mass >= 7 cm in any uni-dimensional measurement)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C13324 (NCI Thesaurus ValueDomain)
C0229601 (UMLS 2011AA ValueDomain)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Code List
Hematopoietic Diagnosis (Mark one with an X. see Section 4.1.1 Histologically confirmed follicular lymphoma, WHO classification grade 1, 2, or 3a without histologic transformation that is stage III, IV or bulky stage II i.e., single mass >= 7 cm in any uni-dimensional measurement)
CL Item
Follicular Lymphoma Grade I (Follicular lymphoma - grade I)
CL Item
Follicular Lymphoma Grade II (Follicular lymphoma - grade II)
CL Item
Follicular Lymphoma Grade IIIa (Follicular lymphoma - grade IIIa)
Item
Modified Ann Arbor Stage (Mark one with an X. see Section 4.1.1)
text
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
Code List
Modified Ann Arbor Stage (Mark one with an X. see Section 4.1.1)
Item
Does institutional flow cytometry or immunohistochemistry confirm CD20 antigen expression (Tumor tissue must be confirmed to express the CD20 antigen by institutional flow cytometry or immunohistochemistry. see Section 4.1.2)
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12476 (NCI Thesaurus Property)
C0039194 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38896 (NCI Thesaurus Property)
C0054946 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Does institutional flow cytometry or immunohistochemistry confirm CD20 antigen expression (Tumor tissue must be confirmed to express the CD20 antigen by institutional flow cytometry or immunohistochemistry. see Section 4.1.2)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
BaselineMalignantNeoplasmLongestDiameterMeasurement
Item
Baseline Longest Diameter of Lesion (cm of the largest involved node Patient must have at least one site of measurable disease that is greater than 1 cm in diameter present either on physical exam or imaging studies. see Section 4.1.3 and 4.5)
double
C25213 (NCI Thesaurus ObjectClass)
C1442488 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property)
C1522425 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus ValueDomain)
C1301886 (UMLS 2011AA ValueDomain)
Item
Any prior systemic therapy for NHL other than involved field radiation therapy (No prior therapy for NHL including chemotherapy or immunotherapy e.g., monoclonal antibody-based therapy. Patients may have received involved field radiation therapy. see Section 4.2.1)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Any prior systemic therapy for NHL other than involved field radiation therapy (No prior therapy for NHL including chemotherapy or immunotherapy e.g., monoclonal antibody-based therapy. Patients may have received involved field radiation therapy. see Section 4.2.1)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Any corticosteroid use within two weeks prior to study entry (except for maintenance therapy of non-malignant disease No corticosteroids within two weeks prior to study entry, except for maintenance therapy for a non-malignant disease. see Section 4.2.2)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C0149783 (NCI Metathesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Any corticosteroid use within two weeks prior to study entry (except for maintenance therapy of non-malignant disease No corticosteroids within two weeks prior to study entry, except for maintenance therapy for a non-malignant disease. see Section 4.2.2)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Number of nodal sites (Mark one with an X. Low or intermediate-risk disease by the follicular lymphoma international prognostic index FLIPI score see Section 4.3)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
Code List
Number of nodal sites (Mark one with an X. Low or intermediate-risk disease by the follicular lymphoma international prognostic index FLIPI score see Section 4.3)
CL Item
<= 4 Sites (<= 4 sites)
CL Item
> 4 Sites (> 4 sites)
LaboratoryProcedureHemoglobinResultUnspecifiedValue
Item
Hemoglobin (g/dl)
double
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureLactateDehydrogenaseResultUnspecifiedValue
Item
Lactate Dehydrogenase (LDH U/l)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25184 (NCI Thesaurus Property)
C0022917 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureLactateDehydrogenaseResultSpecifiedUpperLimitofNormalValue
Item
Lactate Dehydrogenase ULN (LDH U/l)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25184 (NCI Thesaurus Property)
C0022917 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain)
C0205369 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
FLIPI score (Mark one with an X)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C3209 (NCI Thesaurus Property)
C0024301 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C15608 (NCI Thesaurus Property)
C0332305 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
FLIPI score (Mark one with an X)
Item
Performance Status (ECOG) (Mark one with an X ECOG performance status <= 2 see Section 4.4)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
Code List
Performance Status (ECOG) (Mark one with an X ECOG performance status <= 2 see Section 4.4)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
Item
Any known CNS involvement (No known CNS involvement by lymphoma see Section 4.6)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C12438 (NCI Thesaurus ObjectClass)
C0927232 (UMLS 2011AA ObjectClass)
Code List
Any known CNS involvement (No known CNS involvement by lymphoma see Section 4.6)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
PersonReportedAgeValue
Item
Age (Age >= 18 years of age see Section 4.7)
double
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Does the patient have HIV infection (HIV+ patients are eligible, provided they meet the parameters in Section 4.8)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Code List
Does the patient have HIV infection (HIV+ patients are eligible, provided they meet the parameters in Section 4.8)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureCD4-PositiveT-LymphocyteHelper-InducerT-LymphocyteOutcomeCount
Item
CD4+ Count (If yes /mm^3)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12537 (NCI Thesaurus Property)
C0039215 (UMLS 2011AA Property)
C12538 (NCI Thesaurus Property)
C0018894 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item
Evidence of coinfection with hepatitis B or C or evidence of a resistant strain of HIV
text
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C14215 (NCI Thesaurus Property)
C0019169 (UMLS 2011AA Property)
C14325 (NCI Thesaurus Property)
C0206437 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Evidence of coinfection with hepatitis B or C or evidence of a resistant strain of HIV
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient on anti-HIV therapy
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16165 (NCI Thesaurus ObjectClass)
C0887947 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Patient on anti-HIV therapy
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
HumanImmunodeficiencyVirusViralLoadAssayPerformedValue
Item
HIV viral load (If no copies HIV RNA/mL)
double
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C51952 (NCI Thesaurus ObjectClass)
C0376705 (UMLS 2011AA ObjectClass)
C16341 (NCI Thesaurus ObjectClass)
C0005507 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HumanImmunodeficiencyVirusViralLoadAssayPerformedValue
Item
HIV viral load (If no copies HIV RNA/mL)
double
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C51952 (NCI Thesaurus ObjectClass)
C0376705 (UMLS 2011AA ObjectClass)
C16341 (NCI Thesaurus ObjectClass)
C0005507 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Is the patient HBV seropositive (HBsAg + HBV seropositive patients HBsAg + are eligible, provided they meet the parameters in Section 4.9)
text
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C41264 (NCI Thesaurus ObjectClass)
C0205473 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C62796 (NCI Thesaurus Property)
C0369334 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Is the patient HBV seropositive (HBsAg + HBV seropositive patients HBsAg + are eligible, provided they meet the parameters in Section 4.9)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If HBsAg+, was HBV DNA testing performed
text
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C41264 (NCI Thesaurus ObjectClass)
C0205473 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C62786 (NCI Thesaurus Property)
C0019168 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
If HBsAg+, was HBV DNA testing performed
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Was evidence of active HBV infection detected
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C0021311 (NCI Metathesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Code List
Was evidence of active HBV infection detected
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Serum or urine Beta-HCG (Non-pregnant and non-nursing see Section 4.10)
text
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C17479 (NCI Thesaurus Property)
C0106132 (UMLS 2011AA Property)
Code List
Serum or urine Beta-HCG (Non-pregnant and non-nursing see Section 4.10)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Not Applicable (Not applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue
Item
ANC (u/l Granulocytes >= 1,000/ul see Section 4.11)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePlateletResultSpecifiedValue
Item
Platelets (u/L Platelets >= 75,000/ul see Section 4.11)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineResultUnspecifiedValue
Item
Serum Creatinine (mL/min Creatinine clearance >= 30 mL/min see Section 4.11)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTotalBilirubinResultValue
Item
Bilirubin (Bilirubin <= 2x ULN* see Section 4.11 * Unless secondary to Gilbert's or hepatic involvement of NHL)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTotalBilirubinResultUpperLimitNormalValue
Item
Bilirubin ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)