Lymphoma, Non-Hodgkin; B-Cell Lymphomas; low grade | Small Lymphocytic Lymphoma | Lymphoma, Small Cleaved-Cell, Follicular | Lymphoma, Mixed-Cell, Follicular | B-Cell Lymphomas; low grade; cell transformation | Lymphoma, Large-Cell, Follicular; de novo
Item
Does the patient have a histologically- confirmed initital diagnosis of low-grade-non-Hodgkin´s B-cell lymphoma according to International Working Formulation [i.e., small lymphocytic (with or without plasmactoid differentiation); follicular, small- cleaved; or follicular, mixed small- cleaved lymphoma], low- grade lymphoma that has transformed to higher grade histology, or de novo follicular, large cell lymphoma?
boolean
C0024305 (UMLS CUI [1,1])
C0079731 (UMLS CUI [1,2])
C1282907 (UMLS CUI [1,3])
C0855095 (UMLS CUI [2])
C0079765 (UMLS CUI [3])
C0079758 (UMLS CUI [4])
C0079731 (UMLS CUI [5,1])
C1282907 (UMLS CUI [5,2])
C0040682 (UMLS CUI [5,3])
C0079745 (UMLS CUI [6,1])
C1515568 (UMLS CUI [6,2])
Date of original diagnosis
Item
Date of original diagnosis
date
C2316983 (UMLS CUI [1])
Item
IWF lymphoma histology at initial diagnosis
text
C0019638 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Code List
IWF lymphoma histology at initial diagnosis
CL Item
small lymphocytic (with or without plasmacytoid differentiation) (1)
CL Item
follicular, small- cleaved (2)
CL Item
follicular, mixed small- cleaved and follicular, large cell (<50% large cell component) (3)
CL Item
follicular, large cell (4)
Transformation
Item
Has transformation occured?
boolean
C0040682 (UMLS CUI [1])
Item
If transformation has occured, intermediate- grade or high- grade?
text
C1320484 (UMLS CUI [1])
C1273126 (UMLS CUI [2])
Code List
If transformation has occured, intermediate- grade or high- grade?
CL Item
intermediate- grade (1)
Date of Transformation
Item
Date of Transformation
date
C0040682 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Sites of disease at protocol entry
text
C0027653 (UMLS CUI [1])
Code List
Sites of disease at protocol entry
Other
Item
If other site of disease, specify
text
C0027653 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
CD20 Antigens | Immunoperoxidase stain; Paraffin Embedded Tissue; Antibodies; Reaction; Positive | Immunoperoxidase stain; Frozen tissue section sample; Antibodies; Reaction; Positive | Flow Cytometry
Item
Does the patient have evidence that their tumor tissue expresses the CD20 antigen? Immunoperoxidase stains of paraffin- embedded tissue showing positive reactivity with L26 antibody or immunoperoxidase stains of frozen tissue showing positive reactivity with Anti-B1 Antibody (Coulter Clone®) or similar commercialliy-available CD20 antibody (greater than 50% of tumor cells are positive) or evidence of CD20 positivity by flow cytometry (greater than 50% of tumor cells are positive) are acceptable evidende of CD20 positivity.
boolean
C0054946 (UMLS CUI [1])
C1441617 (UMLS CUI [2,1])
C1519524 (UMLS CUI [2,2])
C0003241 (UMLS CUI [2,3])
C0443286 (UMLS CUI [2,4])
C1446409 (UMLS CUI [2,5])
C1441617 (UMLS CUI [3,1])
C4039816 (UMLS CUI [3,2])
C0003241 (UMLS CUI [3,3])
C0443286 (UMLS CUI [3,4])
C1446409 (UMLS CUI [3,5])
C0016263 (UMLS CUI [4])
Rituximab; Response to treatment
Item
Was the patient treated with at least 4doses of rituximab at any time and failed to achieve an objective response (CR, CCR, PR), or relapsed/ progressed during treatment or following the completion of rituximab therapy?
boolean
C0393022 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
C0521982 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0677874 (UMLS CUI [3])
C2347861 (UMLS CUI [4])
C1521726 (UMLS CUI [5])
C0035020 (UMLS CUI [6])
C0242656 (UMLS CUI [7])
Number of Rituxmab therapy doses received
Item
Number of Rituxmab therapy doses received
text
C0393022 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Item
Response to Rituximab therapy
text
C0393022 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
Code List
Response to Rituximab therapy
CL Item
Non- Response (2)
Karnofsky Performance Status | Life Expectancy
Item
Does the patient have a performance status of at least 60% on the Karnofsky Scale and an anticipated survival of at least three months?
boolean
C0206065 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Granulocyte count; Time | Blood Platelets; Time | Cytokine therapy | Blood Transfusion
Item
Does the patient have an absolute granulocyte count > 1.500 cells/mm³ and a platelet count > 100.000 cells/mm³ within 14 days of study entry? These blood counts must be sustained without support of hematopoetic cytokines or transfusion of blood products.
boolean
C0857490 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0005821 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0199974 (UMLS CUI [3])
C0005841 (UMLS CUI [4])
Blood Cell Count; Date in time
Item
Date of blood cell count
date
C0005771 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
ANC
Item
ANC
integer
C0948762 (UMLS CUI [1])
Platelet count
Item
Platelet count
integer
C0005821 (UMLS CUI [1])
Renal function; Liver function
Item
Does the patient have adequate renal function (defined as serum creatinine <1,5 x upper limit of normal) and hepatic function (defined as total bilirubin < 1,5 x upper limit or normal and transaminases [AST and ALT] < 5x upper limit of normal) within 14 days of study entry?
boolean
C0232804 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2,1])
C1519815 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3,1])
C0205411 (UMLS CUI [3,2])
C0201913 (UMLS CUI [4,1])
C1519815 (UMLS CUI [4,2])
C0002594 (UMLS CUI [5,1])
C1519815 (UMLS CUI [5,2])
C0201899 (UMLS CUI [6,1])
C1519815 (UMLS CUI [6,2])
C0201836 (UMLS CUI [7,1])
C1519815 (UMLS CUI [7,2])
C0040223 (UMLS CUI [8])
Date of Creatinine, Bilirubin, AST, ALT measurement
Item
Date of Creatinine, Bilirubin, AST, ALT measurement
date
C0201976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0201899 (UMLS CUI [3,1])
C0011008 (UMLS CUI [3,2])
C0201836 (UMLS CUI [4,1])
C0011008 (UMLS CUI [4,2])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Creatinine ULN
Item
Creatinine ULN
text
C0201976 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Bilirubin
Item
Bilirubin
float
C1278039 (UMLS CUI [1])
Bilirubin ULN
Item
Bilirubin ULN
text
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
AST
Item
AST
float
C0201899 (UMLS CUI [1])
AST ULN
Item
AST ULN
text
C0201899 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
ALT
Item
ALT
float
C0201836 (UMLS CUI [1])
ALT ULN
Item
ALT ULN
text
C0201836 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Measurable Disease | size
Item
Does the patient have bi- dimensionally measurable disease? At least one lesion must be ≤ 2 x 2cm.
boolean
C1513041 (UMLS CUI [1])
C0456389 (UMLS CUI [2])
Age
Item
Is the patient at least 18 years of age?
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
Hast the patient signed the IRB- approved written informed consent form prior to study entry?
boolean
C0021430 (UMLS CUI [1])
Informed consent; Date in time
Item
Date consent signed
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Lymphoma; Bone Marrow Involvement
Item
Does the patient have an average of >25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically at study entry? Verification of bone marrow status is required within 42 days of initial study entry. Bilateral posterior iliac crest core biopsies are required if the percentage of intratabecular space involved exceeds 10% on a unilateral biopsy. The mean of bilateral biopsies must be no more than 25%.
boolean
C0024299 (UMLS CUI [1,1])
C1517677 (UMLS CUI [1,2])
C0005954 (UMLS CUI [1,3])
C0205288 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
C0005953 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C1711411 (UMLS CUI [2,3])
C0040223 (UMLS CUI [2,4])
C0223651 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
C0205095 (UMLS CUI [3,3])
C0238767 (UMLS CUI [3,4])
C1517677 (UMLS CUI [3,5])
C1549488 (UMLS CUI [3,6])
C2348143 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
C0238767 (UMLS CUI [4,3])
C1549488 (UMLS CUI [4,4])
Cytotoxic Chemotherapy; Therapeutic radiology procedure; Immunosuppressive Agents; Cytokine therapy; Nitrosourea Compounds; Toxicity aspects; Glucocorticoids
Item
Has the patient received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry (six weeks for nitrosourea compunds) or continued to exhibit clinical evidence of toxicity? The use of glucocorticoids must be discontinued (except maintenance dose steroids) at least 1 week prior to study entry.
boolean
C0677881 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C2603343 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0021081 (UMLS CUI [3,1])
C2603343 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
C0199974 (UMLS CUI [4,1])
C2603343 (UMLS CUI [4,2])
C0332152 (UMLS CUI [4,3])
C0028210 (UMLS CUI [5,1])
C2603343 (UMLS CUI [5,2])
C0332152 (UMLS CUI [5,3])
C0040539 (UMLS CUI [6])
C0017710 (UMLS CUI [7,1])
C1444662 (UMLS CUI [7,2])
C2603343 (UMLS CUI [7,3])
C0332152 (UMLS CUI [7,4])
C0038317 (UMLS CUI [8,1])
C3714445 (UMLS CUI [8,2])
C0332300 (UMLS CUI [8,3])
Hemopoietic stem cell transplant | high-dose chemotherapy | Chemo-radiotherapy
Item
Has the patient undergone prior hematopoetic stem cell transplant following high- dose chemotherapy or chemo/ radiotherapy?
boolean
C0472699 (UMLS CUI [1])
C1328050 (UMLS CUI [2])
C4264454 (UMLS CUI [3])
Active obstuctive hydronephrosis
Item
Does the patient have active obstuctive hydronephrosis?
boolean
C0020295 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,3])
Active infection; intravenous antibiotics; Time
Item
Does the patient have evidence of active infection requiring intravenous antibiotics at the time of study entry?
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C0348016 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
New York Heart Association Classification | Disease; Other | Illness (finding); Other | Evaluation
Item
Does the patient have New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation?
boolean
C1275491 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0221423 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0220825 (UMLS CUI [4])
Prior malignancy; adequately- treated skin cancer; in situ cervical cancer; disease- free for 5 years
Item
Has the patient had prior malignancy other than lymphoma, except for adequately- treated skin cancer, in situ cervical cancer, or other cancer for wich the patient has been disease- free for 5 years?
boolean
C0006826 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0007114 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0851140 (UMLS CUI [3])
C1707251 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
C0449238 (UMLS CUI [4,4])
HIV Infections
Item
Does the patient have known HIV infection?
boolean
C0019693 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges
Item
Does the patient have known brain or leptomeningeal metastases?
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy test negative; Time | Antibodies; Radiolabeled; Administration procedure
Item
Is the patient pregnant or nursing? Patients of childbearing potential must have a negative pregnancy test result within 7 days of study entry and radiolabeled antibody is not to be administered until a negative result is obtained.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0427780 (UMLS CUI [3,1])
C0040223 (UMLS CUI [3,2])
C0003241 (UMLS CUI [4,1])
C1527121 (UMLS CUI [4,2])
C1533734 (UMLS CUI [4,3])
Hypersensitivity; Iodine | Radiographic iodinated contrast medium; Except for
Item
Has the patient had previous allergic reactions to iodine (with the exception of reactions to intravenous iodine- containing contrast materials)?
boolean
C0020517 (UMLS CUI [1,1])
C0021968 (UMLS CUI [1,2])
C0443076 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
Radioimmunotherapy
Item
Has the patient previously received radioimmunotherapy?
boolean
C0085101 (UMLS CUI [1])
Progressive Disease; Therapeutic radiology procedure; Duration (temporal concept); Total radiation dose delivered Unit
Item
Has the patient had progressive disease within one year of irradiation arising in a field that has been previously irradiated with > 3500 cGy?
boolean
C1335499 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C2919490 (UMLS CUI [1,4])
HAMA- positive
Item
Is the patient HAMA- positive?
boolean
C1291910 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
cancer treatment; Drug Approval
Item
Is the patient receiving either approved or non- approved (through another protocol) anti- cancer drugs or biologics?
boolean
C0920425 (UMLS CUI [1,1])
C0162696 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date of investigation
date
C1261322 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Enrollment authorization
Item
Enrollment authorized by
text
C1516879 (UMLS CUI [1,1])
C0680281 (UMLS CUI [1,2])
Date
Item
Date of authorization
date
C0680281 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Approved dose
text
C0178602 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
Adjust mCi dose for obesity
Item
Adjust mCi dose for obesity
boolean
C1707811 (UMLS CUI [1,1])
C0028754 (UMLS CUI [1,2])