ID

31012

Beschrijving

Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

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Versies (1)
  1. 10-07-18 10-07-18 -
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see clinicaltrials.gov

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10 juli 2018

DOI

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Creative Commons BY 4.0
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Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755

Engels

Patient Eligibility

1 Formulieren  
  1. StudyEvent: ODM
    1. Patient Eligibility
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Does the patient have a histologically confirmed diagnosis of B-cell CLL/PLL/SLL; lymphoplasmacytic-immunocytoma; follicle center, follicular, grade I; or follicle center, follicular grade II non-Hodgkin's lymphoma or one of these B-cell lymphomas which has transformed to a more aggressive histology [according to Revised European-American classification of Lymphoid Neoplasms (REAL)]?
Beschrijving

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Leukemia, Prolymphocytic, B-Cell; Malignant lymphoma - lymphoplasmacytic; Lymphoma, Non-Hodgkin, Grade one rank; Lymphoma, Non-Hodgkin, Grade two rank; Aggressive Non-Hodgkin Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C1302547
UMLS CUI [2]
C0475801
UMLS CUI [3]
C0334633
UMLS CUI [4,1]
C0024305
UMLS CUI [4,2]
C0687695
UMLS CUI [5,1]
C0024305
UMLS CUI [5,2]
C0441802
UMLS CUI [6]
C1332225
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 reativity with Anti-B1 Antibody (>50% of tumor cells are positive) or evidence 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.
Beschrijving

CD20 Antigens, Gene Expression, Tumor tissue sample, Evidence

Datatype

boolean

Alias
UMLS CUI [1,1]
C0054946
UMLS CUI [1,2]
C0017262
UMLS CUI [1,3]
C0475358
UMLS CUI [1,4]
C3887511
Has the patient received 1 or 2 prior chemotherapy regimens and progressed following the last regimen? Patients who have received >2 prior chemotherapy regimens are excluded. Prior therapy with radiation, immunosuppressants, or steroids are not counted as chemotherapy regimens
Beschrijving

Prior Chemotherapy; Disease Progression

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0242656
Does the patient have a performance status of at least 60% on the Karnofsky Scale and an anticipated survival of at least 3 months?
Beschrijving

Karnofsky Performance Status; Survival time, Anticipated

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2,1]
C2919552
UMLS CUI [2,2]
C3840775
Does the patient have an absolute granulocyte count (ANC) >1,500 cells x 10⁹/l and a platelet count >100,000 cells x 10⁹/l within 14 days of study entry? These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
Beschrijving

ANC; Platelet Count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
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 of normal and hepatic transaminases (AST + ALT) < 5 x upper limit of normal] within 14 days of study entry?
Beschrijving

Renal function; Hepatic function

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
Does the patient have bi-dimensionally measured disease? At least one lesion must be ≥ 2 x 2 cm (by CT scan).
Beschrijving

Bi-dimensionally measured disease

Datatype

boolean

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

Age

Datatype

boolean

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

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Date consent signed
Beschrijving

Informed Consent Date

Datatype

date

Alias
UMLS CUI [1]
C2985782
Exclusion criteria
Beschrijving

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 within 42 days of study entry? Bilateral posterior ilia crest 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%.
Beschrijving

Lymphoma, Bone Marrow

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0005953
Has the patient received cytotoxic chemotherapy, radiation therapy, or cytokine treatment within 4 weeks prior to study entry (six weeks for nitrosourea compounds) or exhibited persistent clinical evidence of toxicity? The use of systemic steroids must be discontinued 1 week prior to study entry.
Beschrijving

Prior Chemotherapy, Cytotoxic; Therapeutic radiology procedure, Before; Cytokine therapy, Before; Toxicity aspects

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0677881
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332152
UMLS CUI [3,1]
C0199974
UMLS CUI [3,2]
C0332152
UMLS CUI [4]
C0040539
Has the patient undergone prior hematopoietic stem cell transplant following high dose chemotherapy or chemo/radiotherapy?
Beschrijving

Hemopoietic stem cell transplant Following Chemotherapy Regimen; Hemopoietic stem cell transplant Following Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0472699
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0392920
UMLS CUI [2,1]
C0472699
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C1522449
Does the patient have active obstructive hydronephrosis?
Beschrijving

Hydronephrosis, Obstructed, Active

Datatype

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?
Beschrijving

Communicable Diseases; Antibiotics, Intravenous

Datatype

boolean

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

New York Heart Association Classification; Illness, Serious

Datatype

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
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?
Beschrijving

Malignant Neoplasms, Before

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332152
Does the patient have known HIV infection?
Beschrijving

HIV infection

Datatype

boolean

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

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

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
Is the patient pregnant or breast-feeding? 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.
Beschrijving

Pregnancy; Breast Feeding

Datatype

boolean

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

Iodine, Allergic reaction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021968
UMLS CUI [1,2]
C1527304
Has the patient previously been given any monoclonal or polyclonal antibodies of any non-human species for either diagnostic or therapeutic purposes? This includes engineered chimeric and humanized antibodies.
Beschrijving

Monoclonal Antibodies; Polyclonal antibody

Datatype

boolean

Alias
UMLS CUI [1]
C0003250
UMLS CUI [2]
C0312586
Has the patient previously received radioimmunotherapy?
Beschrijving

Radioimmunotherapy

Datatype

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?
Beschrijving

Progressive Neoplastic Disease, Response to treatment, Radiation Dosage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677932
UMLS CUI [1,2]
C0521982
UMLS CUI [1,3]
C0034524
Is the patient concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics?
Beschrijving

cancer treatment, Concurrent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205420
Has the patient received >2 prior chemotherapy regimens? Prior therapy with radiation, immunosuppressants, or steroids are not counted as chemotherapy regimens.
Beschrijving

Prior Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
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Similar models

Patient Eligibility

1 Formulieren
  1. StudyEvent: ODM
    1. Patient Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Leukemia, Prolymphocytic, B-Cell; Malignant lymphoma - lymphoplasmacytic; Lymphoma, Non-Hodgkin, Grade one rank; Lymphoma, Non-Hodgkin, Grade two rank; Aggressive Non-Hodgkin Lymphoma
Item
Does the patient have a histologically confirmed diagnosis of B-cell CLL/PLL/SLL; lymphoplasmacytic-immunocytoma; follicle center, follicular, grade I; or follicle center, follicular grade II non-Hodgkin's lymphoma or one of these B-cell lymphomas which has transformed to a more aggressive histology [according to Revised European-American classification of Lymphoid Neoplasms (REAL)]?
boolean
C1302547 (UMLS CUI [1])
C0475801 (UMLS CUI [2])
C0334633 (UMLS CUI [3])
C0024305 (UMLS CUI [4,1])
C0687695 (UMLS CUI [4,2])
C0024305 (UMLS CUI [5,1])
C0441802 (UMLS CUI [5,2])
C1332225 (UMLS CUI [6])
CD20 Antigens, Gene Expression, Tumor tissue sample, Evidence
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 reativity with Anti-B1 Antibody (>50% of tumor cells are positive) or evidence 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
C0054946 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C0475358 (UMLS CUI [1,3])
C3887511 (UMLS CUI [1,4])
Prior Chemotherapy; Disease Progression
Item
Has the patient received 1 or 2 prior chemotherapy regimens and progressed following the last regimen? Patients who have received >2 prior chemotherapy regimens are excluded. Prior therapy with radiation, immunosuppressants, or steroids are not counted as chemotherapy regimens
boolean
C1514457 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
Karnofsky Performance Status; Survival time, Anticipated
Item
Does the patient have a performance status of at least 60% on the Karnofsky Scale and an anticipated survival of at least 3 months?
boolean
C0206065 (UMLS CUI [1])
C2919552 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
ANC; Platelet Count
Item
Does the patient have an absolute granulocyte count (ANC) >1,500 cells x 10⁹/l and a platelet count >100,000 cells x 10⁹/l 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])
Renal function; 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 as total bilirubin < 1,5 x upper limit of normal and hepatic transaminases (AST + ALT) < 5 x upper limit of normal] within 14 days of study entry?
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Bi-dimensionally measured disease
Item
Does the patient have bi-dimensionally measured disease? At least one lesion must be ≥ 2 x 2 cm (by CT scan).
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 Ethics Committee-approved written informed consent form prior to study entry?
boolean
C0021430 (UMLS CUI [1])
Informed Consent Date
Item
Date consent signed
date
C2985782 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Lymphoma, Bone Marrow
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 within 42 days of study entry? Bilateral posterior ilia crest 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
C0024299 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Prior Chemotherapy, Cytotoxic; Therapeutic radiology procedure, Before; Cytokine therapy, Before; Toxicity aspects
Item
Has the patient received cytotoxic chemotherapy, radiation therapy, or cytokine treatment within 4 weeks prior to study entry (six weeks for nitrosourea compounds) or exhibited persistent clinical evidence of toxicity? The use of systemic steroids must be discontinued 1 week prior to study entry.
boolean
C1514457 (UMLS CUI [1,1])
C0677881 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0199974 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
C0040539 (UMLS CUI [4])
Hemopoietic stem cell transplant Following Chemotherapy Regimen; Hemopoietic stem cell transplant Following Therapeutic radiology procedure
Item
Has the patient undergone prior hematopoietic stem cell transplant following high dose chemotherapy or chemo/radiotherapy?
boolean
C0472699 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0472699 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
Hydronephrosis, Obstructed, Active
Item
Does the patient have active obstructive hydronephrosis?
boolean
C0020295 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,3])
Communicable Diseases; Antibiotics, Intravenous
Item
Does the patient have evidence of active infection requiring intravenous antibiotics at the time of study entry?
boolean
C0009450 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
C0348016 (UMLS CUI [1,3])
New York Heart Association Classification; Illness, Serious
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])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Malignant Neoplasms, Before
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
C0006826 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
HIV infection
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
Item
Is the patient pregnant or breast-feeding? 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])
Iodine, Allergic reaction
Item
Has the patient had previous allergic reaction to iodine (with the exception of reactions to intravenous iodine-containing contrast materials)?
boolean
C0021968 (UMLS CUI [1,1])
C1527304 (UMLS CUI [1,2])
Monoclonal Antibodies; Polyclonal antibody
Item
Has the patient previously been given any monoclonal or polyclonal antibodies of any non-human species for either diagnostic or therapeutic purposes? This includes engineered chimeric and humanized antibodies.
boolean
C0003250 (UMLS CUI [1])
C0312586 (UMLS CUI [2])
Radioimmunotherapy
Item
Has the patient previously received radioimmunotherapy?
boolean
C0085101 (UMLS CUI [1])
Progressive Neoplastic Disease, Response to treatment, Radiation Dosage
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
C0677932 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
C0034524 (UMLS CUI [1,3])
cancer treatment, Concurrent
Item
Is the patient concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics?
boolean
C0920425 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
Prior Chemotherapy
Item
Has the patient received >2 prior chemotherapy regimens? Prior therapy with radiation, immunosuppressants, or steroids are not counted as chemotherapy regimens.
boolean
C1514457 (UMLS CUI [1])
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