ID

42073

Description

Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

Keywords

Versions (1)
  1. 3/17/21 3/17/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 17, 2021

DOI

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License

Creative Commons BY 4.0
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Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758

English

Patient Enrollment - Patient Eligibility

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Site Number
Description

Site Number

Data type

integer

Alias
UMLS CUI [1,1]
C2825164
UMLS CUI [1,2]
C0237753
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. 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 differenciation]; follicular small cleaved, or follicular, mixed small cleaved and large cell), or low-grade lymphoma that has transformed to a higher grade histology, or de novo follicular large cell lymphoma?
Description

1. Lymphoma, Non-Hodgkin; B-Cell Lymphomas; Low Grade | Small Lymphocytic Lymphoma | Lymphoma, Small Cleaved-Cell, Follicular; Lymphoma, Mixed-Cell, Follicular | cell transformation | Lymphoma, Small Cleaved-Cell, Follicular; Lymphoma, Large-Cell, Follicular; de novo

Data type

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0079731
UMLS CUI [1,3]
C1282907
UMLS CUI [2]
C0855095
UMLS CUI [3,1]
C0079765
UMLS CUI [3,2]
C0079758
UMLS CUI [4]
C0040682
UMLS CUI [5,1]
C0079765
UMLS CUI [5,2]
C0079745
UMLS CUI [5,3]
C1515568
Date of original diagnosis
Description

Date of original diagnosis

Data type

date

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

IWF lymphoma histology at initial diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0024299
UMLS CUI [1,3]
C4071762
Has transformation occured?
Description

Has transformation occured?

Data type

boolean

Alias
UMLS CUI [1]
C1536010
If transformation has occured, specify.
Description

If transformation has occured, specify.

Data type

integer

Alias
UMLS CUI [1,1]
C1536010
UMLS CUI [1,2]
C2348235
Date of transformation
Description

Date of transformation

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1536010
2. Does the patient have Anne Arbor Stage IV disease and greater than an average of 25% of the intratrabecular marrow space involved by NHL in bilateral bone marrow biopsy specimens as assessed microscopically at study entry? A unilateral bone marrow biopsy demonstrating >50% involvement with NHL is also adequate for study entry. Verification of bone marrow status is required within 42 days of study entry.
Description

2. Ann Arbor lymphoma staging system | Bone Marrow Involvement | Lymphoma, Non-Hodgkin | Bone marrow biopsy; Microscopy

Data type

boolean

Alias
UMLS CUI [1]
C0432516
UMLS CUI [2]
C1517677
UMLS CUI [3]
C0024305
UMLS CUI [4,1]
C0005954
UMLS CUI [4,2]
C0026018
3. Has the patient been previously treated with chemotherapy and progressed on, failed to achieve an objective response on, or progressed after completion of their last chemotherapy?
Description

3. Prior Therapy; Chemotherapy Regimen | Disease Progression | Disease Response; Failed | Chemotherapy Regimen; Complete

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0392920
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C1704632
UMLS CUI [3,2]
C0231175
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0205197
4. Does the patient have evidence that their tumor tissue expresses the CD20 antigen? Immunoperoxidase stains of parrafin-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 commercialy available CD20 antibody (>50% of tumor cells are positive) or evidende 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

4. Tumor tissue sample; CD20 Antigens | Paraffin Embedded Tissue; Immunoperoxidase stain | Antibodies | Frozen tissue section sample | Neoplastic Cell | Flow Cytometry

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0054946
UMLS CUI [2,1]
C1519524
UMLS CUI [2,2]
C1441617
UMLS CUI [3]
C0003241
UMLS CUI [4]
C4039816
UMLS CUI [5]
C0597032
UMLS CUI [6]
C0016263
5. Does the patient have a performance status of at least 60% on the Karnofsky Performance Scale and an anticipated survival of at least 3 months?
Description

5. Does the patient have a performance status of at least 60% on the Karnofsky Performance Scale and an anticipated survival of at least 3 months?

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C0023671
6. Does the patient have an ANC >= 1500 cells/mm^3 and a platelet count >= 150,000 cells/mm^3 within 14 days of study entry? These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
Description

6. Absolute neutrophil count | Platelet Count measurement | Hematopoietic; cytokine | Blood Component Transfusion

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3,1]
C0229601
UMLS CUI [3,2]
C0079189
UMLS CUI [4]
C0085430
Hematology Test Date
Description

Hematology Test Date

Data type

date

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C2826247
ANC
Description

ANC

Data type

integer

Measurement units
  • /mm^3
Alias
UMLS CUI [1]
C0948762
/mm^3
Platelet count
Description

Platelet count

Data type

integer

Measurement units
  • /mm^3
Alias
UMLS CUI [1]
C0032181
/mm^3
7. Does the patient have adequate renal function (defined as serum creatinine <1.5 times the upper limit of normal) and hepatic function (defined as total bilirubin < 1.5 times the upper limit of normal and AST < 5 times the upper limit of normal) within 14 days of study entry?
Description

7. Renal function | Creatinine measurement, serum (procedure); Upper Limit of Normal | Liver function | Bilirubin, total measurement; Upper Limit of Normal | Aspartate aminotransferase measurement; Upper Limit of Normal

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2,1]
C0201976
UMLS CUI [2,2]
C1519815
UMLS CUI [3]
C0232741
UMLS CUI [4,1]
C0201913
UMLS CUI [4,2]
C1519815
UMLS CUI [5,1]
C0201899
UMLS CUI [5,2]
C1519815
Date of Clinical Chemistry Test
Description

Date of Clinical Chemistry Test

Data type

date

Alias
UMLS CUI [1,1]
C0525044
UMLS CUI [1,2]
C2826247
Creatinine
Description

Creatinine

Data type

float

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

Creatinine ULN

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1519815
mg/dL
Bilirubin
Description

Bilirubin

Data type

float

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

Bilirubin ULN

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519815
mg/dL
AST
Description

AST

Data type

float

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

AST ULN

Data type

float

Measurement units
  • IU/L
Alias
UMLS CUI [1,1]
C0242192
UMLS CUI [1,2]
C1519815
IU/L
8. Does the patient have bi-dimensionally measurable disease? At least one lesion must be >= 2 x 2 cm.
Description

8. Does the patient have bi-dimensionally measurable disease? At least one lesion must be >= 2 x 2 cm.

Data type

boolean

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

9. Is the patient at least 18 years of age?

Data type

boolean

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

10. Has the patient signed the IRB-approved written informed consent form prior to study entry?

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Date consent signed
Description

Date consent signed

Data type

date

Alias
UMLS CUI [1]
C2985782
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. Does the patient have active obstructive hydronephrosis?
Description

1. Does the patient have active obstructive hydronephrosis?

Data type

boolean

Alias
UMLS CUI [1,1]
C0020295
UMLS CUI [1,2]
C0549186
UMLS CUI [1,3]
C0205177
2. Does the patient have New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation?
Description

2. Does the patient have New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation?

Data type

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
3. Does the patient have a 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

3. Does the patient have a 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?

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0024299
UMLS CUI [2,1]
C0007114
UMLS CUI [2,2]
C0920425
UMLS CUI [2,3]
C0205411
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0332296
4. Does the patient have known HIV infection?
Description

4. Does the patient have known HIV infection?

Data type

boolean

Alias
UMLS CUI [1]
C0019693
5. Is the patient HAMA positive?
Description

5. Is the patient HAMA positive?

Data type

boolean

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1446409
6. Does the patient have known brain or leptomeningeal metastases?
Description

6. Does the patient have known brain or leptomeningeal metastases?

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
7. Has the patient undergone therapy with either stem cell or bone marrow transplant?
Description

7. Has the patient undergone therapy with either stem cell or bone marrow transplant?

Data type

boolean

Alias
UMLS CUI [1]
C0842093
8. Has the patient received cytotoxic chemotherapy, immunosuppressants, or cytokine therapy within 4 weeks prior to study entry (6 weeks for nitrosurea compounds)? The use of systemic steroids must be discontinued at least 1 week prior to study entry.
Description

8. Has the patient received cytotoxic chemotherapy, immunosuppressants, or cytokine therapy within 4 weeks prior to study entry (6 weeks for nitrosurea compounds)? The use of systemic steroids must be discontinued at least 1 week prior to study entry.

Data type

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C0021081
UMLS CUI [3]
C0199974
UMLS CUI [4,1]
C2825233
UMLS CUI [4,2]
C0457454
9. Is the patient pregnant or breastfeeding? Patients of childbearing potential must undergo a urine or serum pregnancy test within 7 days of study entry and radiolabeled antibody is not to be administered until a negative result is obtained. Males and females must agree to use effective contraception for 6 months following the radioimmunotherapy dose.
Description

9. Pregnancy | Breast Feeding | Childbearing Potential | Urine pregnancy test | Serum pregnancy test (B-HCG) | Monoclonal Antibodies; Radiolabeled | Contraceptive methods | Radioimmunotherapy

Data type

integer

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
UMLS CUI [4]
C0430056
UMLS CUI [5]
C0430060
UMLS CUI [6,1]
C0003250
UMLS CUI [6,2]
C1527121
UMLS CUI [7]
C0700589
UMLS CUI [8]
C0085101
10. Does the patient have progressive disease within 1 year of irrigation arising in a field that has been previously irradiated with more than 3500 cGy?
Description

10. Does the patient have progressive disease within 1 year of irrigation arising in a field that has been previously irradiated with more than 3500 cGy?

Data type

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2]
C0022100
11. Is the patient concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics?
Description

11. Is the patient concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics?

Data type

boolean

Alias
UMLS CUI [1]
C0920425
12. Does the patient have active infection requiring IV anti-infectives at the time of study entry?
Description

12. Does the patient have active infection requiring IV anti-infectives at the time of study entry?

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0348016
UMLS CUI [2,2]
C0003232
13. Has the patient previously received radioimmunotherapy?
Description

13. Has the patient previously received radioimmunotherapy?

Data type

boolean

Alias
UMLS CUI [1]
C0085101
14. Does the patient have de novo intermediate- or high-grade NHL, except for intermediate subtype of follicular large cell NHL?
Description

14. Does the patient have de novo intermediate- or high-grade NHL, except for intermediate subtype of follicular large cell NHL?

Data type

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C1512863
UMLS CUI [2,1]
C0024305
UMLS CUI [2,2]
C1515568
UMLS CUI [2,3]
C1273126
UMLS CUI [3,1]
C0079745
UMLS CUI [3,2]
C1512863
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Similar models

Patient Enrollment - Patient Eligibility

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site Number
Item
Site Number
integer
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
1. Lymphoma, Non-Hodgkin; B-Cell Lymphomas; Low Grade | Small Lymphocytic Lymphoma | Lymphoma, Small Cleaved-Cell, Follicular; Lymphoma, Mixed-Cell, Follicular | cell transformation | Lymphoma, Small Cleaved-Cell, Follicular; Lymphoma, Large-Cell, Follicular; de novo
Item
1. 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 differenciation]; follicular small cleaved, or follicular, mixed small cleaved and large cell), or low-grade lymphoma that has transformed to a higher grade histology, or de novo follicular large cell lymphoma?
boolean
C0024305 (UMLS CUI [1,1])
C0079731 (UMLS CUI [1,2])
C1282907 (UMLS CUI [1,3])
C0855095 (UMLS CUI [2])
C0079765 (UMLS CUI [3,1])
C0079758 (UMLS CUI [3,2])
C0040682 (UMLS CUI [4])
C0079765 (UMLS CUI [5,1])
C0079745 (UMLS CUI [5,2])
C1515568 (UMLS CUI [5,3])
Date of original 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])
C4071762 (UMLS CUI [1,3])
IWF lymphoma histology at initial diagnosis
Code List
IWF lymphoma histology at initial diagnosis
CL Item
small lymphocytic (with or withoutplasmacytoid differenciation) (1)
CL Item
follicular small cleaved (2)
CL Item
follicular, mixed small cleaved and large cell (3)
CL Item
low-grade lymphoma that has transformed to a higher grade histology (4)
CL Item
de novo follicular large cell (5)
Has transformation occured?
Item
Has transformation occured?
boolean
C1536010 (UMLS CUI [1])
Item
If transformation has occured, specify.
integer
C1536010 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
If transformation has occured, specify.
Code List
If transformation has occured, specify.
CL Item
Intermediate-grade (1)
CL Item
High-grade (2)
Date of transformation
Item
Date of transformation
date
C0011008 (UMLS CUI [1,1])
C1536010 (UMLS CUI [1,2])
2. Ann Arbor lymphoma staging system | Bone Marrow Involvement | Lymphoma, Non-Hodgkin | Bone marrow biopsy; Microscopy
Item
2. Does the patient have Anne Arbor Stage IV disease and greater than an average of 25% of the intratrabecular marrow space involved by NHL in bilateral bone marrow biopsy specimens as assessed microscopically at study entry? A unilateral bone marrow biopsy demonstrating >50% involvement with NHL is also adequate for study entry. Verification of bone marrow status is required within 42 days of study entry.
boolean
C0432516 (UMLS CUI [1])
C1517677 (UMLS CUI [2])
C0024305 (UMLS CUI [3])
C0005954 (UMLS CUI [4,1])
C0026018 (UMLS CUI [4,2])
3. Prior Therapy; Chemotherapy Regimen | Disease Progression | Disease Response; Failed | Chemotherapy Regimen; Complete
Item
3. Has the patient been previously treated with chemotherapy and progressed on, failed to achieve an objective response on, or progressed after completion of their last chemotherapy?
boolean
C1514463 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C1704632 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
4. Tumor tissue sample; CD20 Antigens | Paraffin Embedded Tissue; Immunoperoxidase stain | Antibodies | Frozen tissue section sample | Neoplastic Cell | Flow Cytometry
Item
4. Does the patient have evidence that their tumor tissue expresses the CD20 antigen? Immunoperoxidase stains of parrafin-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 commercialy available CD20 antibody (>50% of tumor cells are positive) or evidende 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
C0475358 (UMLS CUI [1,1])
C0054946 (UMLS CUI [1,2])
C1519524 (UMLS CUI [2,1])
C1441617 (UMLS CUI [2,2])
C0003241 (UMLS CUI [3])
C4039816 (UMLS CUI [4])
C0597032 (UMLS CUI [5])
C0016263 (UMLS CUI [6])
5. Does the patient have a performance status of at least 60% on the Karnofsky Performance Scale and an anticipated survival of at least 3 months?
Item
5. Does the patient have a performance status of at least 60% on the Karnofsky Performance Scale and an anticipated survival of at least 3 months?
boolean
C0206065 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
6. Absolute neutrophil count | Platelet Count measurement | Hematopoietic; cytokine | Blood Component Transfusion
Item
6. Does the patient have an ANC >= 1500 cells/mm^3 and a platelet count >= 150,000 cells/mm^3 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])
C0229601 (UMLS CUI [3,1])
C0079189 (UMLS CUI [3,2])
C0085430 (UMLS CUI [4])
Hematology Test Date
Item
Hematology Test Date
date
C0018941 (UMLS CUI [1,1])
C2826247 (UMLS CUI [1,2])
ANC
Item
ANC
integer
C0948762 (UMLS CUI [1])
Platelet count
Item
Platelet count
integer
C0032181 (UMLS CUI [1])
7. Renal function | Creatinine measurement, serum (procedure); Upper Limit of Normal | Liver function | Bilirubin, total measurement; Upper Limit of Normal | Aspartate aminotransferase measurement; Upper Limit of Normal
Item
7. Does the patient have adequate renal function (defined as serum creatinine <1.5 times the upper limit of normal) and hepatic function (defined as total bilirubin < 1.5 times the upper limit of normal and AST < 5 times the upper limit of normal) within 14 days of study entry?
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2,1])
C1519815 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3])
C0201913 (UMLS CUI [4,1])
C1519815 (UMLS CUI [4,2])
C0201899 (UMLS CUI [5,1])
C1519815 (UMLS CUI [5,2])
Date of Clinical Chemistry Test
Item
Date of Clinical Chemistry Test
date
C0525044 (UMLS CUI [1,1])
C2826247 (UMLS CUI [1,2])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Creatinine ULN
Item
Creatinine ULN
float
C0201976 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Bilirubin
Item
Bilirubin
float
C1278039 (UMLS CUI [1])
Bilirubin ULN
Item
Bilirubin ULN
float
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
AST
Item
AST
float
C0201899 (UMLS CUI [1])
AST ULN
Item
AST ULN
float
C0242192 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
8. Does the patient have bi-dimensionally measurable disease? At least one lesion must be >= 2 x 2 cm.
Item
8. Does the patient have bi-dimensionally measurable disease? At least one lesion must be >= 2 x 2 cm.
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
9. Is the patient at least 18 years of age?
Item
9. Is the patient at least 18 years of age?
boolean
C0001779 (UMLS CUI [1])
10. Has the patient signed the IRB-approved written informed consent form prior to study entry?
Item
10. Has the patient signed the IRB-approved written informed consent form prior to study entry?
boolean
C0021430 (UMLS CUI [1])
Date consent signed
Item
Date consent signed
date
C2985782 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
1. Does the patient have active obstructive hydronephrosis?
Item
1. Does the patient have active obstructive hydronephrosis?
boolean
C0020295 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,3])
2. Does the patient have New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation?
Item
2. 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])
3. Does the patient have a 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?
Item
3. Does the patient have a 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])
C0205394 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0007114 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
4. Does the patient have known HIV infection?
Item
4. Does the patient have known HIV infection?
boolean
C0019693 (UMLS CUI [1])
5. Is the patient HAMA positive?
Item
5. Is the patient HAMA positive?
boolean
C1291910 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
6. Does the patient have known brain or leptomeningeal metastases?
Item
6. Does the patient have known brain or leptomeningeal metastases?
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
7. Has the patient undergone therapy with either stem cell or bone marrow transplant?
Item
7. Has the patient undergone therapy with either stem cell or bone marrow transplant?
boolean
C0842093 (UMLS CUI [1])
8. Has the patient received cytotoxic chemotherapy, immunosuppressants, or cytokine therapy within 4 weeks prior to study entry (6 weeks for nitrosurea compounds)? The use of systemic steroids must be discontinued at least 1 week prior to study entry.
Item
8. Has the patient received cytotoxic chemotherapy, immunosuppressants, or cytokine therapy within 4 weeks prior to study entry (6 weeks for nitrosurea compounds)? The use of systemic steroids must be discontinued at least 1 week prior to study entry.
boolean
C0677881 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0199974 (UMLS CUI [3])
C2825233 (UMLS CUI [4,1])
C0457454 (UMLS CUI [4,2])
Item
9. Is the patient pregnant or breastfeeding? Patients of childbearing potential must undergo a urine or serum pregnancy test within 7 days of study entry and radiolabeled antibody is not to be administered until a negative result is obtained. Males and females must agree to use effective contraception for 6 months following the radioimmunotherapy dose.
integer
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0430056 (UMLS CUI [4])
C0430060 (UMLS CUI [5])
C0003250 (UMLS CUI [6,1])
C1527121 (UMLS CUI [6,2])
C0700589 (UMLS CUI [7])
C0085101 (UMLS CUI [8])
9. Pregnancy | Breast Feeding | Childbearing Potential | Urine pregnancy test | Serum pregnancy test (B-HCG) | Monoclonal Antibodies; Radiolabeled | Contraceptive methods | Radioimmunotherapy
Code List
9. Is the patient pregnant or breastfeeding? Patients of childbearing potential must undergo a urine or serum pregnancy test within 7 days of study entry and radiolabeled antibody is not to be administered until a negative result is obtained. Males and females must agree to use effective contraception for 6 months following the radioimmunotherapy dose.
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
10. Does the patient have progressive disease within 1 year of irrigation arising in a field that has been previously irradiated with more than 3500 cGy?
Item
10. Does the patient have progressive disease within 1 year of irrigation arising in a field that has been previously irradiated with more than 3500 cGy?
boolean
C1335499 (UMLS CUI [1])
C0022100 (UMLS CUI [2])
11. Is the patient concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics?
Item
11. Is the patient concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics?
boolean
C0920425 (UMLS CUI [1])
12. Does the patient have active infection requiring IV anti-infectives at the time of study entry?
Item
12. Does the patient have active infection requiring IV anti-infectives at the time of study entry?
boolean
C0009450 (UMLS CUI [1])
C0348016 (UMLS CUI [2,1])
C0003232 (UMLS CUI [2,2])
13. Has the patient previously received radioimmunotherapy?
Item
13. Has the patient previously received radioimmunotherapy?
boolean
C0085101 (UMLS CUI [1])
14. Does the patient have de novo intermediate- or high-grade NHL, except for intermediate subtype of follicular large cell NHL?
Item
14. Does the patient have de novo intermediate- or high-grade NHL, except for intermediate subtype of follicular large cell NHL?
boolean
C0024305 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C1512863 (UMLS CUI [1,3])
C0024305 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C1273126 (UMLS CUI [2,3])
C0079745 (UMLS CUI [3,1])
C1512863 (UMLS CUI [3,2])
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