ID

30221

Description

https://clinicaltrials.gov/show/NCT00989664 Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Link

https://clinicaltrials.gov/show/NCT00989664

Keywords

Versions (2)
  1. 4/30/18 4/30/18 -
  2. 5/22/18 5/22/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

May 22, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
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Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664

English

Patient Enrollment, Demographics and Eligibility check

1 forms  
Administration
Description

Administration

Alias
UMLS CUI-1
C1320722
Site Number:
Description

Site Number

Data type

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Patient Number
Description

Patient Number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
Patient body weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Patient height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Patient date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
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 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?
Description

Non-Hodgkins B-cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0024305
Date of original diagnosis
Description

Date of diagnosis

Data type

date

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

IWF lymphoma histology

Data type

integer

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0024299
Has transformation occurred?
Description

Transformation

Data type

boolean

Alias
UMLS CUI [1]
C1510411
If Yes:
Description

Transformation

Data type

integer

Alias
UMLS CUI [1]
C1510411
Date of transformation
Description

Date of transformation

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1510411
Sites of disease at protocol entry:
Description

Sites of disease

Data type

integer

Alias
UMLS CUI [1]
C0027653
Does the patient have evidence that they 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 commercially-available CD20 antibody (greater than 50% of tumor cells are positive) are acceptable evidence of CD20 positivity.
Description

CD20 Positivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0054946
UMLS CUI [1,2]
C0024299
Was the patient treated with at least 4 doses 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?
Description

Rituximab therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0393022
Number of rituximab therapy doses received
Description

Number of rituximab doses

Data type

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0393022
Effect of rituximab therapy
Description

Effect of rituximab therapy

Data type

integer

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0393022
Does the patient have a performance status of at least 60 on the Karnofsky Scale and an anticipated survival of at least three months?
Description

Karnofsky Scale and life expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0206065
UMLS CUI [1,2]
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 hematopoietic cytokines or transfusion of blood products.
Description

Granulocyte and platelet count

Data type

boolean

Alias
UMLS CUI [1,1]
C0857490
UMLS CUI [1,2]
C0005821
Date
Description

Date of blood sample

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
ANC
Description

ANC

Data type

integer

Measurement units
  • mm³
Alias
UMLS CUI [1]
C0948762
mm³
Platelet count
Description

Platelet count

Data type

integer

Measurement units
  • mm^3
Alias
UMLS CUI [1]
C0005821
mm^3
Does the patient have adequate renal function (defined as serum creatinine <1,5 x upper limit of normal) and hepatic function [defined ad total bilirubin <1,5 x upper limit of normal and transaminase (AST and ALT) <5 x upper limit of normal] within 14 days of study entry?
Description

Renal and hepatic function

Data type

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0232741
Date
Description

Date of laboratory tests

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022885
Creatinine
Description

Creatinine

Data type

float

Measurement units
  • mg/dL; ULN
Alias
UMLS CUI [1]
C0201976
mg/dL; ULN
Bilirubin
Description

Bilirubin

Data type

float

Measurement units
  • mg/dL; ULN
Alias
UMLS CUI [1]
C1278039
mg/dL; ULN
AST
Description

AST

Data type

float

Measurement units
  • IU/L; ULN
Alias
UMLS CUI [1]
C0201899
IU/L; ULN
ALT
Description

ALT

Data type

float

Measurement units
  • IU/L; ULN
Alias
UMLS CUI [1]
C0201836
IU/L; ULN
Does the patient have bi-dimensional measurable disease? At least one lesion must be ≥ 2x2 cm.
Description

Bi-dimensional measurable disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
Is the patient at least 18 years of age?
Description

Age

Data type

boolean

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

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Date consent signed
Description

Date of informed consent

Data type

date

Alias
UMLS CUI [1]
C2985782
Exclusion criteria
Description

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 intratrabecular space involved exceeds 10% on a unilateral biopsy. The mean of bilateral biopsies must be no more than 25%.
Description

Bone marrow involved in Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C1517677
UMLS CUI [2]
C0005954
Has the patient received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry (six weeks for nitrosourea compounds) 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.
Description

Cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021081
UMLS CUI [4]
C0199974
Has the patient undergone prior hematopoietic stem cell transplant following high-dose chemotherapy or chemo/radiotherapy?
Description

Stem cell transplant and chemo/radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3874407
UMLS CUI [1,2]
C0279134
Does the patient have active obstructive hydronephrosis?
Description

Obstructive hydronephrosis

Data type

boolean

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

Active infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
Does the patient have New York Heart Association class III or IV heart disease or another serious illness that would preclude evaluation?
Description

NYHA heart disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
Has the patient had 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?
Description

Cancer history

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0006826
Does the patient have known HIV infection?
Description

HIV infection

Data type

boolean

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

Brain or leptomeningeal metastases

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C1704231
Is the patient pregnant or nursing? Patient of childbearing potential mist 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.
Description

Pregnancy or nursing

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Has the patient had previous allergic reactions to iodine (with the exception of reactions to intravenous iodine-containing contrast materials)?
Description

Allergic reactions to iodine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021968
Has the patient previously received radioimmunotherapy?
Description

Radioimmunotherapy

Data type

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?
Description

Progressive disease in field of irradiation

Data type

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C2169147
Is the patient HAMA-positive?
Description

HAMA positivity

Data type

boolean

Alias
UMLS CUI [1]
C3541258
Is the patient receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics?
Description

Anti-cancer drugs or biologics

Data type

boolean

Alias
UMLS CUI [1]
C0920425
Administration
Description

Administration

Alias
UMLS CUI-1
C1320722
Investigator signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Signature date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Patient Enrollment Authorized by
Description

Patient Enrollment Authorized

Data type

text

Alias
UMLS CUI [1,1]
C1555472
UMLS CUI [1,2]
C2700391
UMLS CUI [1,3]
C4041024
Date
Description

Date

Data type

date

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

Approved dose

Data type

integer

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

Adjust mCi dose

Data type

boolean

Alias
UMLS CUI [1]
C1707811
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Similar models

Patient Enrollment, Demographics and Eligibility check

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Site Number
Item
Site Number:
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Weight
Item
Patient body weight
float
C0005910 (UMLS CUI [1])
Height
Item
Patient height
integer
C0005890 (UMLS CUI [1])
Date of birth
Item
Patient date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
M (1)
CL Item
F (2)
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Non-Hodgkins B-cell lymphoma
Item
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 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])
Date of 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])
IWF lymphoma histology
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 occurred?
boolean
C1510411 (UMLS CUI [1])
Item
If Yes:
integer
C1510411 (UMLS CUI [1])
Transformation
Code List
If Yes:
CL Item
Intermediate-grade (1)
CL Item
High-grade (2)
Date of transformation
Item
Date of transformation
date
C0011008 (UMLS CUI [1,1])
C1510411 (UMLS CUI [1,2])
Item
Sites of disease at protocol entry:
integer
C0027653 (UMLS CUI [1])
Sites of disease
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)
CD20 Positivity
Item
Does the patient have evidence that they 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 commercially-available CD20 antibody (greater than 50% of tumor cells are positive) are acceptable evidence of CD20 positivity.
boolean
C0054946 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Rituximab therapy
Item
Was the patient treated with at least 4 doses 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
C1514463 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
Number of rituximab doses
Item
Number of rituximab therapy doses received
integer
C0178602 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0393022 (UMLS CUI [1,3])
Item
Effect of rituximab therapy
integer
C1514463 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
Effect of rituximab therapy
Code List
Effect of rituximab therapy
CL Item
progression (1)
CL Item
non-response (2)
Karnofsky Scale and 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 [1,1])
C0023671 (UMLS CUI [1,2])
Granulocyte and platelet count
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 hematopoietic cytokines or transfusion of blood products.
boolean
C0857490 (UMLS CUI [1,1])
C0005821 (UMLS CUI [1,2])
Date of blood sample
Item
Date
date
C0022885 (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 and hepatic function
Item
Does the patient have adequate renal function (defined as serum creatinine <1,5 x upper limit of normal) and hepatic function [defined ad total bilirubin <1,5 x upper limit of normal and transaminase (AST and ALT) <5 x upper limit of normal] within 14 days of study entry?
boolean
C0232804 (UMLS CUI [1,1])
C0232741 (UMLS CUI [1,2])
Date of laboratory tests
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Bilirubin
Item
Bilirubin
float
C1278039 (UMLS CUI [1])
AST
Item
AST
float
C0201899 (UMLS CUI [1])
ALT
Item
ALT
float
C0201836 (UMLS CUI [1])
Bi-dimensional measurable disease
Item
Does the patient have bi-dimensional measurable disease? At least one lesion must be ≥ 2x2 cm.
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
Age
Item
Is the patient at least 18 years of age?
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
Has the patient signed the IRB-approved written informed consent form prior to study entry?
boolean
C0021430 (UMLS CUI [1])
Date of informed consent
Item
Date consent signed
date
C2985782 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Bone marrow involved in Lymphoma
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 intratrabecular space involved exceeds 10% on a unilateral biopsy. The mean of bilateral biopsies must be no more than 25%.
boolean
C1517677 (UMLS CUI [1])
C0005954 (UMLS CUI [2])
Cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment
Item
Has the patient received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry (six weeks for nitrosourea compounds) 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
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0199974 (UMLS CUI [4])
Stem cell transplant and chemo/radiotherapy
Item
Has the patient undergone prior hematopoietic stem cell transplant following high-dose chemotherapy or chemo/radiotherapy?
boolean
C3874407 (UMLS CUI [1,1])
C0279134 (UMLS CUI [1,2])
Obstructive hydronephrosis
Item
Does the patient have active obstructive hydronephrosis?
boolean
C0020295 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
Active infection
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])
NYHA heart disease
Item
Does the patient have New York Heart Association class III or IV heart disease or another serious illness that would preclude evaluation?
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cancer history
Item
Has the patient had 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
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
HIV infection
Item
Does the patient have known HIV infection?
boolean
C0019693 (UMLS CUI [1])
Brain or leptomeningeal metastases
Item
Does the patient have known brain or leptomeningeal metastases?
boolean
C0220650 (UMLS CUI [1,1])
C1704231 (UMLS CUI [1,2])
Pregnancy or nursing
Item
Is the patient pregnant or nursing? Patient of childbearing potential mist 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])
Allergic reactions to iodine
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])
Radioimmunotherapy
Item
Has the patient previously received radioimmunotherapy?
boolean
C0085101 (UMLS CUI [1])
Progressive disease in field of irradiation
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])
C2169147 (UMLS CUI [1,2])
HAMA positivity
Item
Is the patient HAMA-positive?
boolean
C3541258 (UMLS CUI [1])
Anti-cancer drugs or biologics
Item
Is the patient receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics?
boolean
C0920425 (UMLS CUI [1])
Item Group
Administration
C1320722 (UMLS CUI-1)
Signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Signature date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Patient Enrollment Authorized
Item
Patient Enrollment Authorized by
text
C1555472 (UMLS CUI [1,1])
C2700391 (UMLS CUI [1,2])
C4041024 (UMLS CUI [1,3])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0680281 (UMLS CUI [1,2])
Item
Approved dose
integer
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
Item
Adjust mCi dose for obesity
boolean
C1707811 (UMLS CUI [1])
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