ID

12837

Descripción

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

Link

https://clinicaltrials.gov/show/NCT01536561

Palabras clave

Versiones (1)
  1. 29/12/15 29/12/15 -
Subido en

29 de diciembre de 2015

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma, Non-Hodgkin NCT01536561

Inglés

Eligibility Lymphoma, Non-Hodgkin NCT01536561

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

subjects had histologically-confirmed nhl.

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0054946
Exclusion Criteria
Descripción

Exclusion Criteria

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

≥25% bone marrow involvement.

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1517033
pregnancy
Descripción

pregnancy

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

known brain metastases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
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Similar models

Eligibility Lymphoma, Non-Hodgkin NCT01536561

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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