ID

18023

Description

A Study Of Pharmacokinetics, Whole Body And Organ Dosimetry, And Biodistribution Of Fission-Derived Iodine I 131 Tositumomab (BEXXAR®) For Patients With Previously Untreated Or Relapsed Follicular Or Transformed Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00315731

Link

https://clinicaltrials.gov/show/NCT00315731

Keywords

Versions (1)
  1. 10/14/16 10/14/16 -
Uploaded on

October 14, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma, Follicular NCT00315731

English

Eligibility Lymphoma, Follicular NCT00315731

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. at least 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. a histologically confirmed diagnosis of the following:
Description

Diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0011900
follicular lymphoma, grade 1, 2, or 3 or diffuse large cell lymphoma concurrent with or following the diagnosis of follicular lymphoma (world health organization/revised european-american lymphoma [who/real] classification).
Description

Lymphoma, Follicular | Ann Arbor lymphoma staging system | Diffuse Large B-Cell Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0024301
UMLS CUI [2]
C0432516
UMLS CUI [3]
C0079744
international working formulation histological equivalents included:
Description

Equivalent Histological

Data type

boolean

Alias
UMLS CUI [1,1]
C0205163
UMLS CUI [1,2]
C0205462
follicular, small-cleaved; follicular, mixed small-cleaved and large-cell; follicular large-cell; or transformed diffuse large-cell lymphoma following or concurrent with a diagnosis of follicular lymphoma.
Description

Lymphoma, Small Cleaved-Cell, Follicular | Lymphoma, Mixed-Cell, Follicular | Lymphoma, Large-Cell, Follicular | Diffuse Large B-Cell Lymphoma Transformed | Lymphoma, Follicular

Data type

boolean

Alias
UMLS CUI [1]
C0079765
UMLS CUI [2]
C0079758
UMLS CUI [3]
C0079745
UMLS CUI [4,1]
C0079744
UMLS CUI [4,2]
C0457344
UMLS CUI [5]
C0024301
3. stage iii or iv disease at the time of study entry (based on ann arbor staging classification)
Description

Ann Arbor lymphoma staging system

Data type

boolean

Alias
UMLS CUI [1]
C0432516
4. previously untreated or recurrent lymphoma after no more than 4 prior qualifying therapy regimens; steroids alone, as treatment for lymphoma, not considered a treatment regimen
Description

Lymphoma untreated | Non-Hodgkin's lymphoma recurrent | Therapeutic procedure Quantity | Steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0854866
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0038317
5. performance status of at least 70% on the karnofsky performance scale and an anticipated survival of at least 3 months.
Description

Karnofsky Performance Status | Continuance of life Anticipated

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2,1]
C0038952
UMLS CUI [2,2]
C3840775
6. bi dimensionally measurable disease with at least one lesion measuring greater than or equal to 2.0 cm x 2.0 cm (greater than or equal to 4.0 cm2) by computed tomography (ct) scan
Description

Measurable Disease 2-Dimensional | Lesion Quantity | Lesion size | X-Ray Computed Tomography

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0456389
UMLS CUI [4]
C0040405
7. absolute b lymphocyte count (as determined by cd19 reactivity [flow cytometric determination of cd19+ b lymphocyte count]) of 30 to 350 cell/mm3 within 21 days prior to study enrollment
Description

Absolute B-Cell Lymphocyte Counts | CD19 Antigens Reactivity | Flow Cytometry | blood CD19+ absolute count

Data type

boolean

Alias
UMLS CUI [1]
C1254969
UMLS CUI [2,1]
C0108748
UMLS CUI [2,2]
C0443286
UMLS CUI [3]
C0016263
UMLS CUI [4]
C2208728
8. absolute neutrophil count greater than or equal to 1500 cells/mm3; platelet count greater than or equal to 150,000/mm3; and hemoglobin greater than or equal to 10 g/dl within 21 days prior to study enrollment; blood products and/or growth factors not taken within 4 weeks prior to blood draw
Description

Absolute neutrophil count | Platelet Count measurement | Hemoglobin | Blood product | Growth Factor

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0019046
UMLS CUI [4]
C0456388
UMLS CUI [5]
C0018284
9. adequate renal function, defined as serum creatinine <1.5 x upper limit of normal (uln), and hepatic function, defined as total bilirubin <1.5 x uln and aspartate transaminase (ast) <5 x uln, within 21 days of study enrollment
Description

Renal function | Creatinine measurement, serum | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0232741
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
10. hama negative within 21 days prior to study enrollment
Description

Human anti-mouse antibody Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1513916
11. signed irb approved consent form prior to any study-specific procedures being implemented
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. greater than 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 90 days of study enrollment; a unilateral bone marrow biopsy was adequate; marrow core was greater than or equal to 2.0 cm in length
Description

Bone Marrow Percentage Involvement with Lymphoma | Bone marrow biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0024299
UMLS CUI [2]
C0005954
2. prior chemotherapy, biologic therapy, steroids, or radiation therapy as treatment for nhl within 28 days prior to study enrollment; subjects receiving low doses of steroids for non neoplastic disease acceptable to enter this study ("low dose steroids" was defined as less than or equal to 10 mg of prednisone or equivalent per day.)
Description

Therapeutic procedure Non-Hodgkin Lymphoma | Prior Chemotherapy | Biological treatment | Steroids | Therapeutic radiology procedure | Prednisone

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0024305
UMLS CUI [2]
C1514457
UMLS CUI [3]
C1531518
UMLS CUI [4]
C0038317
UMLS CUI [5]
C1522449
UMLS CUI [6]
C0032952
3. prior rituximab therapy within 120 days prior to study enrollment
Description

rituximab

Data type

boolean

Alias
UMLS CUI [1]
C0393022
4. prior radioimmunotherapy
Description

Radioimmunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0085101
5. prior splenectomy
Description

Splenectomy

Data type

boolean

Alias
UMLS CUI [1]
C0037995
6. splenomegaly defined as spleen mass greater than 700 grams, where splenic mass was defined as follows:
Description

Splenomegaly | Mass of spleen gram

Data type

boolean

Alias
UMLS CUI [1]
C0038002
UMLS CUI [2,1]
C3670837
UMLS CUI [2,2]
C0439208
spleen mass = л(x x y x z)/6 where x and y are the greatest perpendicular diameters in cm on any single ct scan slice, and z is the number of ct scan slices upon which the spleen is visible times the slice thickness in cm
Description

Mass of spleen | Formula | X-Ray Computed Tomography

Data type

boolean

Alias
UMLS CUI [1]
C3670837
UMLS CUI [2]
C0489829
UMLS CUI [3]
C0040405
7. bulky disease as defined as any uni-dimensional measurement of lymphomatous mass exceeding 7 cm
Description

Bulky Disease | Measurement Mass Lymphomatous

Data type

boolean

Alias
UMLS CUI [1]
C1511341
UMLS CUI [2,1]
C0242485
UMLS CUI [2,2]
C0577559
UMLS CUI [2,3]
C0024299
8. prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the subject had a generally accepted risk of recurrence less than 20%
Description

Malignant Neoplasms | Lymphoma | Skin carcinoma Treated | Carcinoma in situ of uterine cervix Treated | Malignant Neoplasm Recurrence Risk Percentage

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0024299
UMLS CUI [3,1]
C0699893
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0851140
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C2986492
UMLS CUI [5,3]
C0439165
9. central nervous system involvement by lymphoma
Description

Central Nervous System Involvement Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0024299
10. evidence of active infection requiring iv antibiotics at the time of study enrollment
Description

Communicable Disease Evidence Requirement Intravenous antibiotic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0559680
11. known human immunodeficiency virus (hiv) infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
12. 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 Excludes Evaluation

Data type

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0332196
UMLS CUI [2,4]
C1261322
13. active obstructive hydronephrosis
Description

Hydronephrosis Obstructive

Data type

boolean

Alias
UMLS CUI [1,1]
C0020295
UMLS CUI [1,2]
C0549186
14. evidence of clinically significant ascites or pleural effusion observed on screening physical examination or baseline ct scan
Description

Ascites Clinical Significance Evidence of | Pleural effusion Clinical Significance Evidence of | Physical Examination | X-Ray Computed Tomography

Data type

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0332120
UMLS CUI [2,1]
C0032227
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C0332120
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0040405
15. prior myeloablative therapy
Description

Myeloablative Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1513784
16. history of failed stem cell collection
Description

Stem Cell Isolation failed

Data type

boolean

Alias
UMLS CUI [1,1]
C3827940
UMLS CUI [1,2]
C0231175
17. pregnant or nursing subjects (subjects of childbearing potential had to have a negative serum pregnancy test within 21 days of study enrollment. males and females of childbearing age had to agree to use effective contraception for up to 12 months after the radioimmunotherapy.)
Description

Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods | Radioimmunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C0085101
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Similar models

Eligibility Lymphoma, Follicular NCT00315731

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Diagnosis
Item
2. a histologically confirmed diagnosis of the following:
boolean
C0011900 (UMLS CUI [1])
Lymphoma, Follicular | Ann Arbor lymphoma staging system | Diffuse Large B-Cell Lymphoma
Item
follicular lymphoma, grade 1, 2, or 3 or diffuse large cell lymphoma concurrent with or following the diagnosis of follicular lymphoma (world health organization/revised european-american lymphoma [who/real] classification).
boolean
C0024301 (UMLS CUI [1])
C0432516 (UMLS CUI [2])
C0079744 (UMLS CUI [3])
Equivalent Histological
Item
international working formulation histological equivalents included:
boolean
C0205163 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
Lymphoma, Small Cleaved-Cell, Follicular | Lymphoma, Mixed-Cell, Follicular | Lymphoma, Large-Cell, Follicular | Diffuse Large B-Cell Lymphoma Transformed | Lymphoma, Follicular
Item
follicular, small-cleaved; follicular, mixed small-cleaved and large-cell; follicular large-cell; or transformed diffuse large-cell lymphoma following or concurrent with a diagnosis of follicular lymphoma.
boolean
C0079765 (UMLS CUI [1])
C0079758 (UMLS CUI [2])
C0079745 (UMLS CUI [3])
C0079744 (UMLS CUI [4,1])
C0457344 (UMLS CUI [4,2])
C0024301 (UMLS CUI [5])
Ann Arbor lymphoma staging system
Item
3. stage iii or iv disease at the time of study entry (based on ann arbor staging classification)
boolean
C0432516 (UMLS CUI [1])
Lymphoma untreated | Non-Hodgkin's lymphoma recurrent | Therapeutic procedure Quantity | Steroids
Item
4. previously untreated or recurrent lymphoma after no more than 4 prior qualifying therapy regimens; steroids alone, as treatment for lymphoma, not considered a treatment regimen
boolean
C0024299 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0854866 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0038317 (UMLS CUI [4])
Karnofsky Performance Status | Continuance of life Anticipated
Item
5. performance status of at least 70% on the karnofsky performance scale and an anticipated survival of at least 3 months.
boolean
C0206065 (UMLS CUI [1])
C0038952 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
Measurable Disease 2-Dimensional | Lesion Quantity | Lesion size | X-Ray Computed Tomography
Item
6. bi dimensionally measurable disease with at least one lesion measuring greater than or equal to 2.0 cm x 2.0 cm (greater than or equal to 4.0 cm2) by computed tomography (ct) scan
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C0040405 (UMLS CUI [4])
Absolute B-Cell Lymphocyte Counts | CD19 Antigens Reactivity | Flow Cytometry | blood CD19+ absolute count
Item
7. absolute b lymphocyte count (as determined by cd19 reactivity [flow cytometric determination of cd19+ b lymphocyte count]) of 30 to 350 cell/mm3 within 21 days prior to study enrollment
boolean
C1254969 (UMLS CUI [1])
C0108748 (UMLS CUI [2,1])
C0443286 (UMLS CUI [2,2])
C0016263 (UMLS CUI [3])
C2208728 (UMLS CUI [4])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin | Blood product | Growth Factor
Item
8. absolute neutrophil count greater than or equal to 1500 cells/mm3; platelet count greater than or equal to 150,000/mm3; and hemoglobin greater than or equal to 10 g/dl within 21 days prior to study enrollment; blood products and/or growth factors not taken within 4 weeks prior to blood draw
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
C0456388 (UMLS CUI [4])
C0018284 (UMLS CUI [5])
Renal function | Creatinine measurement, serum | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement
Item
9. adequate renal function, defined as serum creatinine <1.5 x upper limit of normal (uln), and hepatic function, defined as total bilirubin <1.5 x uln and aspartate transaminase (ast) <5 x uln, within 21 days of study enrollment
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
Human anti-mouse antibody Negative
Item
10. hama negative within 21 days prior to study enrollment
boolean
C1291910 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Informed Consent
Item
11. signed irb approved consent form prior to any study-specific procedures being implemented
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bone Marrow Percentage Involvement with Lymphoma | Bone marrow biopsy
Item
1. greater than 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 90 days of study enrollment; a unilateral bone marrow biopsy was adequate; marrow core was greater than or equal to 2.0 cm in length
boolean
C0005953 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0024299 (UMLS CUI [1,4])
C0005954 (UMLS CUI [2])
Therapeutic procedure Non-Hodgkin Lymphoma | Prior Chemotherapy | Biological treatment | Steroids | Therapeutic radiology procedure | Prednisone
Item
2. prior chemotherapy, biologic therapy, steroids, or radiation therapy as treatment for nhl within 28 days prior to study enrollment; subjects receiving low doses of steroids for non neoplastic disease acceptable to enter this study ("low dose steroids" was defined as less than or equal to 10 mg of prednisone or equivalent per day.)
boolean
C0087111 (UMLS CUI [1,1])
C0024305 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0038317 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
C0032952 (UMLS CUI [6])
rituximab
Item
3. prior rituximab therapy within 120 days prior to study enrollment
boolean
C0393022 (UMLS CUI [1])
Radioimmunotherapy
Item
4. prior radioimmunotherapy
boolean
C0085101 (UMLS CUI [1])
Splenectomy
Item
5. prior splenectomy
boolean
C0037995 (UMLS CUI [1])
Splenomegaly | Mass of spleen gram
Item
6. splenomegaly defined as spleen mass greater than 700 grams, where splenic mass was defined as follows:
boolean
C0038002 (UMLS CUI [1])
C3670837 (UMLS CUI [2,1])
C0439208 (UMLS CUI [2,2])
Mass of spleen | Formula | X-Ray Computed Tomography
Item
spleen mass = л(x x y x z)/6 where x and y are the greatest perpendicular diameters in cm on any single ct scan slice, and z is the number of ct scan slices upon which the spleen is visible times the slice thickness in cm
boolean
C3670837 (UMLS CUI [1])
C0489829 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
Bulky Disease | Measurement Mass Lymphomatous
Item
7. bulky disease as defined as any uni-dimensional measurement of lymphomatous mass exceeding 7 cm
boolean
C1511341 (UMLS CUI [1])
C0242485 (UMLS CUI [2,1])
C0577559 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
Malignant Neoplasms | Lymphoma | Skin carcinoma Treated | Carcinoma in situ of uterine cervix Treated | Malignant Neoplasm Recurrence Risk Percentage
Item
8. prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the subject had a generally accepted risk of recurrence less than 20%
boolean
C0006826 (UMLS CUI [1])
C0024299 (UMLS CUI [2])
C0699893 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0851140 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0006826 (UMLS CUI [5,1])
C2986492 (UMLS CUI [5,2])
C0439165 (UMLS CUI [5,3])
Central Nervous System Involvement Lymphoma
Item
9. central nervous system involvement by lymphoma
boolean
C4050309 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Communicable Disease Evidence Requirement Intravenous antibiotic therapy
Item
10. evidence of active infection requiring iv antibiotics at the time of study enrollment
boolean
C0009450 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0559680 (UMLS CUI [1,4])
HIV Infection
Item
11. known human immunodeficiency virus (hiv) infection
boolean
C0019693 (UMLS CUI [1])
New York Heart Association Classification | Illness Serious Excludes Evaluation
Item
12. 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])
C0332196 (UMLS CUI [2,3])
C1261322 (UMLS CUI [2,4])
Hydronephrosis Obstructive
Item
13. active obstructive hydronephrosis
boolean
C0020295 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
Ascites Clinical Significance Evidence of | Pleural effusion Clinical Significance Evidence of | Physical Examination | X-Ray Computed Tomography
Item
14. evidence of clinically significant ascites or pleural effusion observed on screening physical examination or baseline ct scan
boolean
C0003962 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0032227 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0332120 (UMLS CUI [2,3])
C0031809 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
Myeloablative Chemotherapy
Item
15. prior myeloablative therapy
boolean
C1513784 (UMLS CUI [1])
Stem Cell Isolation failed
Item
16. history of failed stem cell collection
boolean
C3827940 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods | Radioimmunotherapy
Item
17. pregnant or nursing subjects (subjects of childbearing potential had to have a negative serum pregnancy test within 21 days of study enrollment. males and females of childbearing age had to agree to use effective contraception for up to 12 months after the radioimmunotherapy.)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0085101 (UMLS CUI [5])
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