ID

13054

Beschrijving

Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00268203

Link

https://clinicaltrials.gov/show/NCT00268203

Trefwoorden

  1. 13-01-16 13-01-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

13 januari 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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Eligibility Lymphoma, Non-Hodgkin NCT00268203

Eligibility Lymphoma, Non-Hodgkin NCT00268203

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed diagnosis of low- grade nhl or transformed low-grade nhl (tumor must be cd 20 positive).
Beschrijving

non-hodgkin's lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0024305
prior treatment with at least one chemotherapy regimen and have relapsed or progressed, or failed to achieve an objective response on last chemotherapy regimen.
Beschrijving

chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
karnofsky performance status of at least 60% and anticipated survival of at least 3 months.
Beschrijving

karnofsky performance status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
absolute granulocyte of >/= 1,500/mm3.
Beschrijving

granulocyte

Datatype

boolean

Alias
UMLS CUI [1]
C0857490
platelet count of >/= 100,000/mm3, and not require sustained support of hematopoietic cytokines, or transfusion of blood products.
Beschrijving

platelet count

Datatype

boolean

Alias
UMLS CUI [1]
C0005821
adequate renal function (i.e., <1.5x upper limit of normal), and hepatic transaminases (ast <5 times uln).
Beschrijving

renal function and hepatic transaminases

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0002594
signed irb/iec-approved informed consent.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a mean of >25% of the intratrabecular marrow space involved with lymphoma.
Beschrijving

intratrabecular marrow space

Datatype

boolean

Alias
UMLS CUI [1]
C0005953
patients who received cytotoxic chemotherapy, radiation therapy, immunotherapy, or cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosurea compounds) or who exhibit persistent clinical evidence of toxicity.
Beschrijving

toxicity

Datatype

boolean

Alias
UMLS CUI [1]
C0040539
patients who have undergone stem cell or bone marrow transplant, active obstructive hydronephrosis, active infection, new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation.
Beschrijving

serious illness

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
known hiv infection.
Beschrijving

hiv

Datatype

boolean

Alias
UMLS CUI [1]
C0019682
pregnant or nursing patients.
Beschrijving

pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer, in-situ cervical cancer, or cancer for which the patient has been disease-free for 5 years.
Beschrijving

prior malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with more than 3500 cgy.
Beschrijving

progressive disease

Datatype

boolean

Alias
UMLS CUI [1]
C1335499
patients who received prior radioimmunotherapy, known brain or leptomeningeal metastases, hama positivity.
Beschrijving

patients who received prior radioimmunotherapy, known brain or leptomeningeal metastases, hama positivity.

Datatype

boolean

Alias
UMLS CUI [1]
C0085101
UMLS CUI [2]
C0220650
UMLS CUI [3]
C1291910
patients who are receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
Beschrijving

anti-cancer drugs or biologics

Datatype

boolean

Alias
UMLS CUI [1]
C0920425

Similar models

Eligibility Lymphoma, Non-Hodgkin NCT00268203

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
non-hodgkin's lymphoma
Item
histologically confirmed diagnosis of low- grade nhl or transformed low-grade nhl (tumor must be cd 20 positive).
boolean
C0024305 (UMLS CUI [1])
chemotherapy
Item
prior treatment with at least one chemotherapy regimen and have relapsed or progressed, or failed to achieve an objective response on last chemotherapy regimen.
boolean
C0392920 (UMLS CUI [1])
karnofsky performance status
Item
karnofsky performance status of at least 60% and anticipated survival of at least 3 months.
boolean
C0206065 (UMLS CUI [1])
granulocyte
Item
absolute granulocyte of >/= 1,500/mm3.
boolean
C0857490 (UMLS CUI [1])
platelet count
Item
platelet count of >/= 100,000/mm3, and not require sustained support of hematopoietic cytokines, or transfusion of blood products.
boolean
C0005821 (UMLS CUI [1])
renal function and hepatic transaminases
Item
adequate renal function (i.e., <1.5x upper limit of normal), and hepatic transaminases (ast <5 times uln).
boolean
C0232804 (UMLS CUI [1])
C0002594 (UMLS CUI [2])
informed consent
Item
signed irb/iec-approved informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
intratrabecular marrow space
Item
patients with a mean of >25% of the intratrabecular marrow space involved with lymphoma.
boolean
C0005953 (UMLS CUI [1])
toxicity
Item
patients who received cytotoxic chemotherapy, radiation therapy, immunotherapy, or cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosurea compounds) or who exhibit persistent clinical evidence of toxicity.
boolean
C0040539 (UMLS CUI [1])
serious illness
Item
patients who have undergone stem cell or bone marrow transplant, active obstructive hydronephrosis, active infection, new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation.
boolean
C0009488 (UMLS CUI [1])
hiv
Item
known hiv infection.
boolean
C0019682 (UMLS CUI [1])
pregnancy
Item
pregnant or nursing patients.
boolean
C0032961 (UMLS CUI [1])
prior malignancy
Item
patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer, in-situ cervical cancer, or cancer for which the patient has been disease-free for 5 years.
boolean
C0006826 (UMLS CUI [1])
progressive disease
Item
patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with more than 3500 cgy.
boolean
C1335499 (UMLS CUI [1])
patients who received prior radioimmunotherapy, known brain or leptomeningeal metastases, hama positivity.
Item
patients who received prior radioimmunotherapy, known brain or leptomeningeal metastases, hama positivity.
boolean
C0085101 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
C1291910 (UMLS CUI [3])
anti-cancer drugs or biologics
Item
patients who are receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
boolean
C0920425 (UMLS CUI [1])

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