ID

12837

Beskrivning

Study of Radiolabeled Monoclonal Antibody Anti-B1 for the Treatment of B-Cell Lymphomas and Extended Study to Determine the Safety and Efficacy of Coulter Clone® 131Iodine-B1 Radioimmunotherapy of Advanced Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01536561

Länk

https://clinicaltrials.gov/show/NCT01536561

Nyckelord

Versioner (1)
  1. 2015-12-29 2015-12-29 -
Uppladdad den

29 december 2015

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Lymphoma, Non-Hodgkin NCT01536561

Engelsk

Eligibility Lymphoma, Non-Hodgkin NCT01536561

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects had histologically-confirmed nhl.
Beskrivning

subjects had histologically-confirmed nhl.

Datatyp

boolean

Alias
UMLS CUI [1]
C0024305
subjects with low-, intermediate-, or high-grade histologies, according to the international working formulation.
Beskrivning

subjects with low-, intermediate-, or high-grade histologies, according to the international working formulation.

Datatyp

boolean

Alias
UMLS CUI [1]
C0919553
subjects had relapsed after or had failed to respond to at least 1 prior chemotherapy regimen.
Beskrivning

subjects had relapsed after or had failed to respond to at least 1 prior chemotherapy regimen.

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
subjects had evidence that their tumor tissue expressed the CD20 antigen.
Beskrivning

subjects had evidence that their tumor tissue expressed the CD20 antigen.

Datatyp

boolean

Alias
UMLS CUI [1]
C0054946
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
≥25% bone marrow involvement.
Beskrivning

≥25% bone marrow involvement.

Datatyp

boolean

Alias
UMLS CUI [1]
C1517677
absolute granulocyte count ≥1500 cells/mm3 or platelet count ≤100,000 platelets/mm3.
Beskrivning

absolute granulocyte count ≥1500 cells/mm3 or platelet count ≤100,000 platelets/mm3.

Datatyp

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0005821
creatinine ≥2.0 mg/dl, bilirubin ≥2.0 mg/dl.
Beskrivning

creatinine ≥2.0 mg/dl, bilirubin ≥2.0 mg/dl.

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks of study entry.
Beskrivning

cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks of study entry.

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021081
UMLS CUI [4]
C0199974
active infection, collagen vascular disease, vasculitis, glomerulonephritis, new york heart association class ii or iv heart disease and/or serious illness.
Beskrivning

active infection, collagen vascular disease, vasculitis, glomerulonephritis, new york heart association class ii or iv heart disease and/or serious illness.

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0262428
UMLS CUI [3]
C0042384
UMLS CUI [4]
C0017658
UMLS CUI [5]
C1536131
UMLS CUI [6]
C1536133
UMLS CUI [7,1]
C0009488
UMLS CUI [7,2]
C0205404
prior external beam radiation therapy such that the maximum tolerated dose level for any normal organ would be exceeded by additional irradiation.
Beskrivning

prior external beam radiation therapy such that the maximum tolerated dose level for any normal organ would be exceeded by additional irradiation.

Datatyp

boolean

Alias
UMLS CUI [1]
C1517033
pregnancy
Beskrivning

pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
allergy to iodine or previous sensitization to mouse protein as documented by positive anti-mouse antibody elisa test.
Beskrivning

allergy to iodine or previous sensitization to mouse protein as documented by positive anti-mouse antibody elisa test.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021968
UMLS CUI [2]
C0237866
known brain metastases
Beskrivning

known brain metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
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Similar models

Eligibility Lymphoma, Non-Hodgkin NCT01536561

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
NHL
Item
subjects had histologically-confirmed nhl.
boolean
C0024305 (UMLS CUI [1])
histologic grade
Item
subjects with low-, intermediate-, or high-grade histologies, according to the international working formulation.
boolean
C0919553 (UMLS CUI [1])
chemotherapy
Item
subjects had relapsed after or had failed to respond to at least 1 prior chemotherapy regimen.
boolean
C0392920 (UMLS CUI [1])
CD20 antigen
Item
subjects had evidence that their tumor tissue expressed the CD20 antigen.
boolean
C0054946 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
bone marrow involvement
Item
≥25% bone marrow involvement.
boolean
C1517677 (UMLS CUI [1])
granulocyte and platelet count
Item
absolute granulocyte count ≥1500 cells/mm3 or platelet count ≤100,000 platelets/mm3.
boolean
C0857490 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
creatinine and bilirubin
Item
creatinine ≥2.0 mg/dl, bilirubin ≥2.0 mg/dl.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
prior therapies
Item
cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks of study entry.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0199974 (UMLS CUI [4])
comorbidities
Item
active infection, collagen vascular disease, vasculitis, glomerulonephritis, new york heart association class ii or iv heart disease and/or serious illness.
boolean
C0009450 (UMLS CUI [1])
C0262428 (UMLS CUI [2])
C0042384 (UMLS CUI [3])
C0017658 (UMLS CUI [4])
C1536131 (UMLS CUI [5])
C1536133 (UMLS CUI [6])
C0009488 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
beam radiation therapy
Item
prior external beam radiation therapy such that the maximum tolerated dose level for any normal organ would be exceeded by additional irradiation.
boolean
C1517033 (UMLS CUI [1])
pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
allergy and sensitization
Item
allergy to iodine or previous sensitization to mouse protein as documented by positive anti-mouse antibody elisa test.
boolean
C0020517 (UMLS CUI [1,1])
C0021968 (UMLS CUI [1,2])
C0237866 (UMLS CUI [2])
brain metastases
Item
known brain metastases
boolean
C0220650 (UMLS CUI [1])
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