ID

31118

Beschreibung

Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Stichworte

Versionen (2)
  1. 07.07.18 07.07.18 -
  2. 21.07.18 21.07.18 -
Rechteinhaber

see clinicaltrials.gov

Hochgeladen am

21. Juli 2018

DOI

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Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593

Englisch

Patient enrollment

1 Formulare  
  1. StudyEvent: ODM
    1. Patient enrollment
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C1704791
Patient Body Weight (kg)
Beschreibung

Patient Body Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Patient Heigth (cm)
Beschreibung

Patient Height

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Inclusion Criteria Histology
Beschreibung

Inclusion Criteria Histology

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0019638
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?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0079731
UMLS CUI [1,3]
C1282907
UMLS CUI [2]
C0855095
UMLS CUI [3]
C0079765
UMLS CUI [4]
C0079758
UMLS CUI [5,1]
C0079731
UMLS CUI [5,2]
C1282907
UMLS CUI [5,3]
C0040682
UMLS CUI [6,1]
C0079745
UMLS CUI [6,2]
C1515568
Date of original diagnosis
Beschreibung

Date of original diagnosis

Datentyp

date

Alias
UMLS CUI [1]
C2316983
IWF lymphoma histology at initial diagnosis
Beschreibung

IWF lymphoma histology at initial diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0024299
UMLS CUI [1,3]
C4071762
Has transformation occured?
Beschreibung

Transformation

Datentyp

boolean

Alias
UMLS CUI [1]
C0040682
If transformation has occured, intermediate- grade or high- grade?
Beschreibung

Intermediate- grade | High-grade

Datentyp

text

Alias
UMLS CUI [1,1]
C0040682
UMLS CUI [1,2]
C1320484
UMLS CUI [2,1]
C0040682
UMLS CUI [2,2]
C1273126
Date of Transformation
Beschreibung

Date of Transformation

Datentyp

date

Alias
UMLS CUI [1,1]
C0040682
UMLS CUI [1,2]
C0011008
Sites of disease at protocol entry
Beschreibung

Sites of disease at protocol entry

Datentyp

text

Alias
UMLS CUI [1]
C0027653
If other site of disease, specify
Beschreibung

Other

Datentyp

text

Alias
UMLS CUI [1,1]
C0027653
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
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.
Beschreibung

CD20 Antigens | Immunoperoxidase stain; Paraffin Embedded Tissue; Antibodies; Reaction; Positive | Immunoperoxidase stain; Frozen tissue section sample; Antibodies; Reaction; Positive | Flow Cytometry

Datentyp

boolean

Alias
UMLS CUI [1]
C0054946
UMLS CUI [2,1]
C1441617
UMLS CUI [2,2]
C1519524
UMLS CUI [2,3]
C0003241
UMLS CUI [2,4]
C0443286
UMLS CUI [2,5]
C1446409
UMLS CUI [3,1]
C1441617
UMLS CUI [3,2]
C4039816
UMLS CUI [3,3]
C0003241
UMLS CUI [3,4]
C0443286
UMLS CUI [3,5]
C1446409
UMLS CUI [4]
C0016263
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?
Beschreibung

Rituximab; Response to treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0393022
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0750480
UMLS CUI [2,1]
C0521982
UMLS CUI [2,2]
C0231175
UMLS CUI [3]
C0677874
UMLS CUI [4]
C2347861
UMLS CUI [5]
C1521726
UMLS CUI [6]
C0035020
UMLS CUI [7]
C0242656
Number of Rituxmab therapy doses received
Beschreibung

Number of Rituxmab therapy doses received

Datentyp

text

Alias
UMLS CUI [1,1]
C0393022
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0750480
Response to Rituximab therapy
Beschreibung

Rituximab; Response to treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C0393022
UMLS CUI [1,2]
C0521982
Does the patient have a performance status of at least 60% on the Karnofsky Scale and an anticipated survival of at least three months?
Beschreibung

Karnofsky Performance Status | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C0023671
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.
Beschreibung

Granulocyte count; Time | Blood Platelets; Time | Cytokine therapy | Blood Transfusion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0857490
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C0005821
UMLS CUI [2,2]
C0040223
UMLS CUI [3]
C0199974
UMLS CUI [4]
C0005841
Date of blood cell count
Beschreibung

Blood Cell Count; Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0011008
ANC
Beschreibung

ANC

Datentyp

integer

Maßeinheiten
  • cells/mm³
Alias
UMLS CUI [1]
C0948762
cells/mm³
Platelet count
Beschreibung

Platelet count

Datentyp

integer

Maßeinheiten
  • cells/mm³
Alias
UMLS CUI [1]
C0005821
cells/mm³
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?
Beschreibung

Renal function; Liver function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205411
UMLS CUI [2,1]
C0201976
UMLS CUI [2,2]
C1519815
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C0205411
UMLS CUI [4,1]
C0201913
UMLS CUI [4,2]
C1519815
UMLS CUI [5,1]
C0002594
UMLS CUI [5,2]
C1519815
UMLS CUI [6,1]
C0201899
UMLS CUI [6,2]
C1519815
UMLS CUI [7,1]
C0201836
UMLS CUI [7,2]
C1519815
UMLS CUI [8]
C0040223
Date of Creatinine, Bilirubin, AST, ALT measurement
Beschreibung

Date of Creatinine, Bilirubin, AST, ALT measurement

Datentyp

date

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C1278039
UMLS CUI [2,2]
C0011008
UMLS CUI [3,1]
C0201899
UMLS CUI [3,2]
C0011008
UMLS CUI [4,1]
C0201836
UMLS CUI [4,2]
C0011008
Creatinine
Beschreibung

Creatinine

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
UMLS CUI [1]
C0201976
mg/dL
Creatinine ULN
Beschreibung

Creatinine ULN

Datentyp

text

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1519815
Bilirubin
Beschreibung

Bilirubin

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
UMLS CUI [1]
C1278039
mg/dL
Bilirubin ULN
Beschreibung

Bilirubin ULN

Datentyp

text

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519815
AST
Beschreibung

AST

Datentyp

float

Maßeinheiten
  • IU/L
Alias
UMLS CUI [1]
C0201899
IU/L
AST ULN
Beschreibung

AST ULN

Datentyp

text

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1519815
ALT
Beschreibung

ALT

Datentyp

float

Maßeinheiten
  • IU/L
Alias
UMLS CUI [1]
C0201836
IU/L
ALT ULN
Beschreibung

ALT ULN

Datentyp

text

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1519815
Does the patient have bi- dimensionally measurable disease? At least one lesion must be ≤ 2 x 2cm.
Beschreibung

Measurable Disease | size

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0456389
Is the patient at least 18 years of age?
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Hast the patient signed the IRB- approved written informed consent form prior to study entry?
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Date consent signed
Beschreibung

Informed consent; Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
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%.
Beschreibung

Lymphoma; Bone Marrow Involvement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1517677
UMLS CUI [1,3]
C0005954
UMLS CUI [1,4]
C0205288
UMLS CUI [1,5]
C0040223
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0449438
UMLS CUI [2,3]
C1711411
UMLS CUI [2,4]
C0040223
UMLS CUI [3,1]
C0223651
UMLS CUI [3,2]
C0005558
UMLS CUI [3,3]
C0205095
UMLS CUI [3,4]
C0238767
UMLS CUI [3,5]
C1517677
UMLS CUI [3,6]
C1549488
UMLS CUI [4,1]
C2348143
UMLS CUI [4,2]
C0005558
UMLS CUI [4,3]
C0238767
UMLS CUI [4,4]
C1549488
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.
Beschreibung

Cytotoxic Chemotherapy; Therapeutic radiology procedure; Immunosuppressive Agents; Cytokine therapy; Nitrosourea Compounds; Toxicity aspects; Glucocorticoids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C0332152
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C2603343
UMLS CUI [2,3]
C0332152
UMLS CUI [3,1]
C0021081
UMLS CUI [3,2]
C2603343
UMLS CUI [3,3]
C0332152
UMLS CUI [4,1]
C0199974
UMLS CUI [4,2]
C2603343
UMLS CUI [4,3]
C0332152
UMLS CUI [5,1]
C0028210
UMLS CUI [5,2]
C2603343
UMLS CUI [5,3]
C0332152
UMLS CUI [6]
C0040539
UMLS CUI [7,1]
C0017710
UMLS CUI [7,2]
C1444662
UMLS CUI [7,3]
C2603343
UMLS CUI [7,4]
C0332152
UMLS CUI [8,1]
C0038317
UMLS CUI [8,2]
C3714445
UMLS CUI [8,3]
C0332300
Has the patient undergone prior hematopoetic stem cell transplant following high- dose chemotherapy or chemo/ radiotherapy?
Beschreibung

Hemopoietic stem cell transplant | high-dose chemotherapy | Chemo-radiotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0472699
UMLS CUI [2]
C1328050
UMLS CUI [3]
C4264454
Does the patient have active obstuctive hydronephrosis?
Beschreibung

Active obstuctive hydronephrosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020295
UMLS CUI [1,2]
C0549186
UMLS CUI [1,3]
C0205177
Does the patient have evidence of active infection requiring intravenous antibiotics at the time of study entry?
Beschreibung

Active infection; intravenous antibiotics; Time

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0003232
UMLS CUI [1,4]
C0348016
UMLS CUI [1,5]
C0040223
Does the patient have New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation?
Beschreibung

New York Heart Association Classification | Disease; Other | Illness (finding); Other | Evaluation

Datentyp

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205394
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205394
UMLS CUI [4]
C0220825
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?
Beschreibung

Prior malignancy; adequately- treated skin cancer; in situ cervical cancer; disease- free for 5 years

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0024299
UMLS CUI [1,3]
C0332152
UMLS CUI [2,1]
C0007114
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0205411
UMLS CUI [3]
C0851140
UMLS CUI [4,1]
C1707251
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0332296
UMLS CUI [4,4]
C0449238
Does the patient have known HIV infection?
Beschreibung

HIV Infections

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
Does the patient have known brain or leptomeningeal metastases?
Beschreibung

Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
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.
Beschreibung

Pregnancy | Breast Feeding | Pregnancy test negative; Time | Antibodies; Radiolabeled; Administration procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0427780
UMLS CUI [3,2]
C0040223
UMLS CUI [4,1]
C0003241
UMLS CUI [4,2]
C1527121
UMLS CUI [4,3]
C1533734
Has the patient had previous allergic reactions to iodine (with the exception of reactions to intravenous iodine- containing contrast materials)?
Beschreibung

Hypersensitivity; Iodine | Radiographic iodinated contrast medium; Except for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021968
UMLS CUI [2,1]
C0443076
UMLS CUI [2,2]
C0443286
UMLS CUI [2,3]
C0332300
Has the patient previously received radioimmunotherapy?
Beschreibung

Radioimmunotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0085101
Has the patient had progressive disease within one year of irradiation arising in a field that has been previously irradiated with > 3500 cGy?
Beschreibung

Progressive Disease; Therapeutic radiology procedure; Duration (temporal concept); Total radiation dose delivered Unit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0449238
UMLS CUI [1,4]
C2919490
Is the patient HAMA- positive?
Beschreibung

HAMA- positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1446409
Is the patient receiving either approved or non- approved (through another protocol) anti- cancer drugs or biologics?
Beschreibung

cancer treatment; Drug Approval

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0162696
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Investigator Signature
Beschreibung

Investigator Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date of investigation
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0011008
For Coulter use only
Beschreibung

For Coulter use only

Enrollment authorized by
Beschreibung

Enrollment authorization

Datentyp

text

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0680281
Date of authorization
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0680281
UMLS CUI [1,2]
C0011008
Approved dose
Beschreibung

Approved dose

Datentyp

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0205540
Adjust mCi dose for obesity
Beschreibung

Adjust mCi dose for obesity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707811
UMLS CUI [1,2]
C0028754
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Ähnliche Modelle

Patient enrollment

1 Formulare
  1. StudyEvent: ODM
    1. Patient enrollment
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Demographics
C1704791 (UMLS CUI-1)
Patient Body Weight
Item
Patient Body Weight (kg)
float
C0005910 (UMLS CUI [1])
Patient Height
Item
Patient Heigth (cm)
float
C0005890 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
male (1)
CL Item
female (2)
Item Group
Inclusion Criteria Histology
C1512693 (UMLS CUI-1)
C0019638 (UMLS CUI-2)
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])
C4071762 (UMLS CUI [1,3])
IWF lymphoma histology at initial diagnosis
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
C0040682 (UMLS CUI [1,1])
C1320484 (UMLS CUI [1,2])
C0040682 (UMLS CUI [2,1])
C1273126 (UMLS CUI [2,2])
Intermediate- grade | High-grade
Code List
If transformation has occured, intermediate- grade or high- grade?
CL Item
intermediate- grade (1)
CL Item
high- grade (2)
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])
Sites of disease at protocol entry
Code List
Sites of disease at protocol entry
CL Item
Head (1)
CL Item
Neck (2)
CL Item
Chest (3)
CL Item
Abdomen (4)
CL Item
Pelvis (5)
CL Item
Skin (6)
CL Item
Other (7)
Other
Item
If other site of disease, specify
text
C0027653 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
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])
Progression | Non- response
Code List
Response to Rituximab therapy
CL Item
Progression (1)
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])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
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])
C0024299 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
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])
C0443286 (UMLS CUI [2,2])
C0332300 (UMLS CUI [2,3])
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])
Item Group
Administrative
C1320722 (UMLS CUI-1)
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])
Item Group
For Coulter use only
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])
Approved dose
Code List
Approved dose
CL Item
65 cGy (1)
CL Item
75 cGy (2)
Adjust mCi dose for obesity
Item
Adjust mCi dose for obesity
boolean
C1707811 (UMLS CUI [1,1])
C0028754 (UMLS CUI [1,2])
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