ID

13627

Beschreibung

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

Stichworte

  1. 21.02.16 21.02.16 -
Hochgeladen am

21. Februar 2016

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Lymphoma, Non-Hodgkin NCT00989664

Eligibility Lymphoma, Non-Hodgkin NCT00989664

Inclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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
Beschreibung

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%.
Beschreibung

lymphoma involvment of bone marrow, iliac crest biopsy

Datentyp

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.
Beschreibung

chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment

Datentyp

boolean

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

stem cell transplant

Datentyp

boolean

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

obstructive hydronephrosis

Datentyp

boolean

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

active infection with iv antibiotics

Datentyp

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.
Beschreibung

new york heart association or other comorbidity precluding evaluation

Datentyp

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.
Beschreibung

malignancies

Datentyp

boolean

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

hiv

Datentyp

boolean

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

brain metastases, leptomeningeal metastases

Datentyp

boolean

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

pregnant or nursing

Datentyp

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.
Beschreibung

allergic reactions to iodine

Datentyp

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.
Beschreibung

Antibodies

Datentyp

boolean

Alias
UMLS CUI [1]
C0003241
prior radioimmunotherapy.
Beschreibung

prior radioimmunotherapy

Datentyp

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.
Beschreibung

progressive disease after radiation, radation dosage

Datentyp

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
Beschreibung

cancer therapy

Datentyp

boolean

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

de novo intermediate- or high-grade lymphoma

Datentyp

boolean

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

Ähnliche Modelle

Eligibility Lymphoma, Non-Hodgkin NCT00989664

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])

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