Informatie:
Fout:
ID
30221
Beschrijving
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
Trefwoorden
Versies (2)
- 30-04-18 30-04-18 -
- 22-05-18 22-05-18 -
Houder van rechten
GlaxoSmithKline (GSK)
Geüploaded op
22 mei 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664
Patient Enrollment, Demographics and Eligibility check
- StudyEvent: ODM
Similar models
Patient Enrollment, Demographics and Eligibility check
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Site Number
Item
Site Number:
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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])
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])
CL Item
M (1)
CL Item
F (2)
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])
C0024299 (UMLS CUI [1,2])
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])
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])
C1510411 (UMLS CUI [1,2])
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])
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])
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])
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])
C0393022 (UMLS CUI [1,2])
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])
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])
C0005821 (UMLS CUI [1,2])
Date of blood sample
Item
Date
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])
C0232741 (UMLS CUI [1,2])
Date of laboratory tests
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
Signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Signature date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])
C2700391 (UMLS CUI [1,2])
C4041024 (UMLS CUI [1,3])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0680281 (UMLS CUI [1,2])
C0680281 (UMLS CUI [1,2])
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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