ID

13627

Descripción

Pivotal Study of Iodine I 131 Tositumomab for Chemotherapy-refractory Low-grade or Transformed Low-grade B-cell Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00989664

Link

https://clinicaltrials.gov/show/NCT00989664

Palabras clave

Versiones (1)
  1. 21/2/16 21/2/16 -
Subido en

21 de febrero de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma, Non-Hodgkin NCT00989664

Inglés

Eligibility Lymphoma, Non-Hodgkin NCT00989664

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects ≥18 years of age with histologically confirmed at initial diagnosis, previously treated (at least 2 prior chemotherapy regimens), low-grade nhl or low-grade lymphoma that had transformed to intermediate- or high-grade histology.
Descripción

Gender, Age, prior chemotherapy, low-grade lymphoma (NHL) transformed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C1514457
UMLS CUI [4]
C0278885
UMLS CUI [5]
C0079747
UMLS CUI [6]
C1536010
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with more than 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 iliac crest core biopsies are required if the percentage of intratrebecular space involved exceeds 10% in a unilateral biopsy. the mean of bilateral biopsies must be no more than 25%.
Descripción

lymphoma involvment of bone marrow, iliac crest biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1301440
UMLS CUI [2]
C0229621
UMLS CUI [3]
C0005954
cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or persistent clinical evidence of toxicity.
Descripción

chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021081
UMLS CUI [4]
C0199974
prior stem cell transplant.
Descripción

stem cell transplant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1504389
active obstructive hydronephrosis.
Descripción

obstructive hydronephrosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020295
evidence of active infection requiring intravenous (iv) antibiotics at the time of study entry.
Descripción

active infection with iv antibiotics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0559680
new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation.
Descripción

new york heart association or other comorbidity precluding evaluation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2]
C0009488
prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 years.
Descripción

malignancies

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
known hiv infection.
Descripción

hiv

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019682
known brain or leptomeningeal metastases.
Descripción

brain metastases, leptomeningeal metastases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
subjects who are pregnant or nursing.
Descripción

pregnant or nursing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
previous allergic reactions to iodine. this does not include reactions to intravenous iodine-containing contrast materials.
Descripción

allergic reactions to iodine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021968
prior exposure to monoclonal or polyclonal antibodies of any non-human species for either diagnostic or therapeutic purposes, including engineered chimeric and humanized antibodies.
Descripción

Antibodies

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003241
prior radioimmunotherapy.
Descripción

prior radioimmunotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085101
progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with >3500 cgy.
Descripción

progressive disease after radiation, radation dosage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0677932
UMLS CUI [2]
C0521982
UMLS CUI [3]
C0034524
current use of either approved or non-approved (through another protocol) anti-cancer drugs or biologics
Descripción

cancer therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0920425
de novo intermediate- or high-grade lymphoma.
Descripción

de novo intermediate- or high-grade lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079741
UMLS CUI [2]
C0079740
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Similar models

Eligibility Lymphoma, Non-Hodgkin NCT00989664

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender, Age, prior chemotherapy, low-grade lymphoma (NHL) transformed
Item
male and female subjects ≥18 years of age with histologically confirmed at initial diagnosis, previously treated (at least 2 prior chemotherapy regimens), low-grade nhl or low-grade lymphoma that had transformed to intermediate- or high-grade histology.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1514457 (UMLS CUI [3])
C0278885 (UMLS CUI [4])
C0079747 (UMLS CUI [5])
C1536010 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
lymphoma involvment of bone marrow, iliac crest biopsy
Item
subjects with more than 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 iliac crest core biopsies are required if the percentage of intratrebecular space involved exceeds 10% in a unilateral biopsy. the mean of bilateral biopsies must be no more than 25%.
boolean
C1301440 (UMLS CUI [1])
C0229621 (UMLS CUI [2])
C0005954 (UMLS CUI [3])
chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment
Item
cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or persistent clinical evidence of toxicity.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0199974 (UMLS CUI [4])
stem cell transplant
Item
prior stem cell transplant.
boolean
C1504389 (UMLS CUI [1])
obstructive hydronephrosis
Item
active obstructive hydronephrosis.
boolean
C0020295 (UMLS CUI [1])
active infection with iv antibiotics
Item
evidence of active infection requiring intravenous (iv) antibiotics at the time of study entry.
boolean
C0009450 (UMLS CUI [1])
C0559680 (UMLS CUI [2])
new york heart association or other comorbidity precluding evaluation
Item
new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation.
boolean
C1275491 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
malignancies
Item
prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 years.
boolean
C0006826 (UMLS CUI [1])
hiv
Item
known hiv infection.
boolean
C0019682 (UMLS CUI [1])
brain metastases, leptomeningeal metastases
Item
known brain or leptomeningeal metastases.
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
pregnant or nursing
Item
subjects who are pregnant or nursing.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
allergic reactions to iodine
Item
previous allergic reactions to iodine. this does not include reactions to intravenous iodine-containing contrast materials.
boolean
C0020517 (UMLS CUI [1,1])
C0021968 (UMLS CUI [1,2])
Antibodies
Item
prior exposure to monoclonal or polyclonal antibodies of any non-human species for either diagnostic or therapeutic purposes, including engineered chimeric and humanized antibodies.
boolean
C0003241 (UMLS CUI [1])
prior radioimmunotherapy
Item
prior radioimmunotherapy.
boolean
C0085101 (UMLS CUI [1])
progressive disease after radiation, radation dosage
Item
progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with >3500 cgy.
boolean
C0677932 (UMLS CUI [1])
C0521982 (UMLS CUI [2])
C0034524 (UMLS CUI [3])
cancer therapy
Item
current use of either approved or non-approved (through another protocol) anti-cancer drugs or biologics
boolean
C0920425 (UMLS CUI [1])
de novo intermediate- or high-grade lymphoma
Item
de novo intermediate- or high-grade lymphoma.
boolean
C0079741 (UMLS CUI [1])
C0079740 (UMLS CUI [2])
Volver a la parte superior de la página 

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