ID

31012

Description

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

Mots-clés

Versions (1)
  1. 10/07/2018 10/07/2018 -
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see clinicaltrials.gov

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10 juillet 2018

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Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755

Anglais

Patient Eligibility

1 Formulaires  
  1. StudyEvent: ODM
    1. Patient Eligibility
Inclusion Criteria
Description

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)]?
Description

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

Type de données

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.
Description

CD20 Antigens, Gene Expression, Tumor tissue sample, Evidence

Type de données

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
Description

Prior Chemotherapy; Disease Progression

Type de données

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?
Description

Karnofsky Performance Status; Survival time, Anticipated

Type de données

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.
Description

ANC; Platelet Count

Type de données

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?
Description

Renal function; Hepatic function

Type de données

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).
Description

Bi-dimensionally measured disease

Type de données

boolean

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

Age

Type de données

boolean

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

Informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Date consent signed
Description

Informed Consent Date

Type de données

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 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%.
Description

Lymphoma, Bone Marrow

Type de données

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.
Description

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

Type de données

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?
Description

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

Type de données

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?
Description

Hydronephrosis, Obstructed, Active

Type de données

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?
Description

Communicable Diseases; Antibiotics, Intravenous

Type de données

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?
Description

New York Heart Association Classification; Illness, Serious

Type de données

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?
Description

Malignant Neoplasms, Before

Type de données

boolean

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

HIV infection

Type de données

boolean

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

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

Type de données

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.
Description

Pregnancy; Breast Feeding

Type de données

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)?
Description

Iodine, Allergic reaction

Type de données

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.
Description

Monoclonal Antibodies; Polyclonal antibody

Type de données

boolean

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

Radioimmunotherapy

Type de données

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 Neoplastic Disease, Response to treatment, Radiation Dosage

Type de données

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?
Description

cancer treatment, Concurrent

Type de données

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.
Description

Prior Chemotherapy

Type de données

boolean

Alias
UMLS CUI [1]
C1514457
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Similar models

Patient Eligibility

1 Formulaires
  1. StudyEvent: ODM
    1. Patient Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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