Site Number
Item
Site Number
integer
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
1. Lymphoma, Non-Hodgkin; B-Cell Lymphomas; Low Grade | Small Lymphocytic Lymphoma | Lymphoma, Small Cleaved-Cell, Follicular; Lymphoma, Mixed-Cell, Follicular | cell transformation | Lymphoma, Small Cleaved-Cell, Follicular; Lymphoma, Large-Cell, Follicular; de novo
Item
1. Does the patient have a histologically confirmed initial diagnosis of low-grade non-Hodgkin's B-cell lymphoma according to International Working Formulation (i.e., small lymphocytic [with or without plasmacytoid differenciation]; follicular small cleaved, or follicular, mixed small cleaved and large cell), or low-grade lymphoma that has transformed to a 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 [3,1])
C0079758 (UMLS CUI [3,2])
C0040682 (UMLS CUI [4])
C0079765 (UMLS CUI [5,1])
C0079745 (UMLS CUI [5,2])
C1515568 (UMLS CUI [5,3])
Date of original diagnosis
Item
Date of original diagnosis
date
C2316983 (UMLS CUI [1])
Item
IWF lymphoma histology at initial diagnosis
integer
C0019638 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
Code List
IWF lymphoma histology at initial diagnosis
CL Item
small lymphocytic (with or withoutplasmacytoid differenciation) (1)
CL Item
follicular small cleaved (2)
CL Item
follicular, mixed small cleaved and large cell (3)
CL Item
low-grade lymphoma that has transformed to a higher grade histology (4)
CL Item
de novo follicular large cell (5)
Has transformation occured?
Item
Has transformation occured?
boolean
C1536010 (UMLS CUI [1])
Item
If transformation has occured, specify.
integer
C1536010 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
If transformation has occured, specify.
CL Item
Intermediate-grade (1)
Date of transformation
Item
Date of transformation
date
C0011008 (UMLS CUI [1,1])
C1536010 (UMLS CUI [1,2])
2. Ann Arbor lymphoma staging system | Bone Marrow Involvement | Lymphoma, Non-Hodgkin | Bone marrow biopsy; Microscopy
Item
2. Does the patient have Anne Arbor Stage IV disease and greater than an average of 25% of the intratrabecular marrow space involved by NHL in bilateral bone marrow biopsy specimens as assessed microscopically at study entry? A unilateral bone marrow biopsy demonstrating >50% involvement with NHL is also adequate for study entry. Verification of bone marrow status is required within 42 days of study entry.
boolean
C0432516 (UMLS CUI [1])
C1517677 (UMLS CUI [2])
C0024305 (UMLS CUI [3])
C0005954 (UMLS CUI [4,1])
C0026018 (UMLS CUI [4,2])
3. Prior Therapy; Chemotherapy Regimen | Disease Progression | Disease Response; Failed | Chemotherapy Regimen; Complete
Item
3. Has the patient been previously treated with chemotherapy and progressed on, failed to achieve an objective response on, or progressed after completion of their last chemotherapy?
boolean
C1514463 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C1704632 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
4. Tumor tissue sample; CD20 Antigens | Paraffin Embedded Tissue; Immunoperoxidase stain | Antibodies | Frozen tissue section sample | Neoplastic Cell | Flow Cytometry
Item
4. Does the patient have evidence that their tumor tissue expresses the CD20 antigen? Immunoperoxidase stains of parrafin-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 commercialy available CD20 antibody (>50% of tumor cells are positive) or evidende of CD20 positivity by flow cytometry (>50% of tumor cells are positive) are acceptable evidence of CD20 positivity. Testing of tumor tissue from any time in the course of the patient's disease is acceptable.
boolean
C0475358 (UMLS CUI [1,1])
C0054946 (UMLS CUI [1,2])
C1519524 (UMLS CUI [2,1])
C1441617 (UMLS CUI [2,2])
C0003241 (UMLS CUI [3])
C4039816 (UMLS CUI [4])
C0597032 (UMLS CUI [5])
C0016263 (UMLS CUI [6])
5. Does the patient have a performance status of at least 60% on the Karnofsky Performance Scale and an anticipated survival of at least 3 months?
Item
5. Does the patient have a performance status of at least 60% on the Karnofsky Performance Scale and an anticipated survival of at least 3 months?
boolean
C0206065 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
6. Absolute neutrophil count | Platelet Count measurement | Hematopoietic; cytokine | Blood Component Transfusion
Item
6. Does the patient have an ANC >= 1500 cells/mm^3 and a platelet count >= 150,000 cells/mm^3 within 14 days of study entry? These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0229601 (UMLS CUI [3,1])
C0079189 (UMLS CUI [3,2])
C0085430 (UMLS CUI [4])
Hematology Test Date
Item
Hematology Test Date
date
C0018941 (UMLS CUI [1,1])
C2826247 (UMLS CUI [1,2])
ANC
Item
ANC
integer
C0948762 (UMLS CUI [1])
Platelet count
Item
Platelet count
integer
C0032181 (UMLS CUI [1])
7. Renal function | Creatinine measurement, serum (procedure); Upper Limit of Normal | Liver function | Bilirubin, total measurement; Upper Limit of Normal | Aspartate aminotransferase measurement; Upper Limit of Normal
Item
7. Does the patient have adequate renal function (defined as serum creatinine <1.5 times the upper limit of normal) and hepatic function (defined as total bilirubin < 1.5 times the upper limit of normal and AST < 5 times the upper limit of normal) within 14 days of study entry?
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2,1])
C1519815 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3])
C0201913 (UMLS CUI [4,1])
C1519815 (UMLS CUI [4,2])
C0201899 (UMLS CUI [5,1])
C1519815 (UMLS CUI [5,2])
Date of Clinical Chemistry Test
Item
Date of Clinical Chemistry Test
date
C0525044 (UMLS CUI [1,1])
C2826247 (UMLS CUI [1,2])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Creatinine ULN
Item
Creatinine ULN
float
C0201976 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Bilirubin
Item
Bilirubin
float
C1278039 (UMLS CUI [1])
Bilirubin ULN
Item
Bilirubin ULN
float
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
AST
Item
AST
float
C0201899 (UMLS CUI [1])
AST ULN
Item
AST ULN
float
C0242192 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
8. Does the patient have bi-dimensionally measurable disease? At least one lesion must be >= 2 x 2 cm.
Item
8. Does the patient have bi-dimensionally measurable disease? At least one lesion must be >= 2 x 2 cm.
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
9. Is the patient at least 18 years of age?
Item
9. Is the patient at least 18 years of age?
boolean
C0001779 (UMLS CUI [1])
10. Has the patient signed the IRB-approved written informed consent form prior to study entry?
Item
10. Has the patient signed the IRB-approved written informed consent form prior to study entry?
boolean
C0021430 (UMLS CUI [1])
Date consent signed
Item
Date consent signed
date
C2985782 (UMLS CUI [1])
1. Does the patient have active obstructive hydronephrosis?
Item
1. Does the patient have active obstructive hydronephrosis?
boolean
C0020295 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,3])
2. Does the patient have New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation?
Item
2. 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])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
3. Does the patient have a prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years?
Item
3. Does the patient have a prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years?
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0007114 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
4. Does the patient have known HIV infection?
Item
4. Does the patient have known HIV infection?
boolean
C0019693 (UMLS CUI [1])
5. Is the patient HAMA positive?
Item
5. Is the patient HAMA positive?
boolean
C1291910 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
6. Does the patient have known brain or leptomeningeal metastases?
Item
6. Does the patient have known brain or leptomeningeal metastases?
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
7. Has the patient undergone therapy with either stem cell or bone marrow transplant?
Item
7. Has the patient undergone therapy with either stem cell or bone marrow transplant?
boolean
C0842093 (UMLS CUI [1])
8. Has the patient received cytotoxic chemotherapy, immunosuppressants, or cytokine therapy within 4 weeks prior to study entry (6 weeks for nitrosurea compounds)? The use of systemic steroids must be discontinued at least 1 week prior to study entry.
Item
8. Has the patient received cytotoxic chemotherapy, immunosuppressants, or cytokine therapy within 4 weeks prior to study entry (6 weeks for nitrosurea compounds)? The use of systemic steroids must be discontinued at least 1 week prior to study entry.
boolean
C0677881 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0199974 (UMLS CUI [3])
C2825233 (UMLS CUI [4,1])
C0457454 (UMLS CUI [4,2])
Item
9. Is the patient pregnant or breastfeeding? Patients of childbearing potential must undergo a urine or serum pregnancy test within 7 days of study entry and radiolabeled antibody is not to be administered until a negative result is obtained. Males and females must agree to use effective contraception for 6 months following the radioimmunotherapy dose.
integer
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0430056 (UMLS CUI [4])
C0430060 (UMLS CUI [5])
C0003250 (UMLS CUI [6,1])
C1527121 (UMLS CUI [6,2])
C0700589 (UMLS CUI [7])
C0085101 (UMLS CUI [8])
Code List
9. Is the patient pregnant or breastfeeding? Patients of childbearing potential must undergo a urine or serum pregnancy test within 7 days of study entry and radiolabeled antibody is not to be administered until a negative result is obtained. Males and females must agree to use effective contraception for 6 months following the radioimmunotherapy dose.
10. Does the patient have progressive disease within 1 year of irrigation arising in a field that has been previously irradiated with more than 3500 cGy?
Item
10. Does the patient have progressive disease within 1 year of irrigation arising in a field that has been previously irradiated with more than 3500 cGy?
boolean
C1335499 (UMLS CUI [1])
C0022100 (UMLS CUI [2])
11. Is the patient concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics?
Item
11. Is the patient concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics?
boolean
C0920425 (UMLS CUI [1])
12. Does the patient have active infection requiring IV anti-infectives at the time of study entry?
Item
12. Does the patient have active infection requiring IV anti-infectives at the time of study entry?
boolean
C0009450 (UMLS CUI [1])
C0348016 (UMLS CUI [2,1])
C0003232 (UMLS CUI [2,2])
13. Has the patient previously received radioimmunotherapy?
Item
13. Has the patient previously received radioimmunotherapy?
boolean
C0085101 (UMLS CUI [1])
14. Does the patient have de novo intermediate- or high-grade NHL, except for intermediate subtype of follicular large cell NHL?
Item
14. Does the patient have de novo intermediate- or high-grade NHL, except for intermediate subtype of follicular large cell NHL?
boolean
C0024305 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C1512863 (UMLS CUI [1,3])
C0024305 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C1273126 (UMLS CUI [2,3])
C0079745 (UMLS CUI [3,1])
C1512863 (UMLS CUI [3,2])