ID

13056

Description

Retreatment of Patients With Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti B1 Antibody; ODM derived from: https://clinicaltrials.gov/show/NCT00938041

Link

https://clinicaltrials.gov/show/NCT00938041

Keywords

Versions (1)
  1. 1/13/16 1/13/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 13, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Lymphoma, Non-Hodgkin NCT00938041

English

Eligibility Lymphoma, Non-Hodgkin NCT00938041

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically confirmed initial diagnosis of non-hodgkin's b-cell lymphoma
Description

non-hodgkin's b-cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0024305
patients must have previously responded with a duration of response of at least 3 months to iodine-131 anti-b1 antibody therapy
Description

iodine-131

Data type

boolean

Alias
UMLS CUI [1]
C0303029
patients must have evidence that their tumor tissue had cd20 expression
Description

cd20 expression

Data type

boolean

Alias
UMLS CUI [1]
C0054946
patients must have performance status of at least 60% on the karnofsky scale and an anticipated survival of at least 3 months
Description

karnofsky performance status and life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C0023671
patients must have absolute granulocyte count (anc) greater than 1,500 cells/mm3 and platelet count greater than 100,000 cells/mm3 within 14 days of study entry without support of hematopoietic cytokines or transfusion of blood products
Description

granulocyte and platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0005821
UMLS CUI [2]
C0857490
patients must have adequate renal (serum creatine less than 1.5 x upper limit of normal) and hepatic function (total bilirubin less than 1.5 x upper limit of normal and hepatic transaminases, ast and alt, less than 5 x upper limit of normal) within 14 days of study entry
Description

renal and hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0002594
patients must have bi-dimensionally measurable disease with a least one lesion greater than or equal to 2 cm x 2 cm by ct scan
Description

measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
patients must be at least 18 years of age
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must give written informed consent and sign an institutional review board/ethics committee- approved informed consent form prior to study entry
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with more than 25% bone marrow involvement
Description

bone marrow involvement

Data type

boolean

Alias
UMLS CUI [1]
C1517677
patients who have received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or who exhibit persistent clinical evidence of toxicity. the use of systemic steroids much be discontinued at least 1 week prior to study entry.
Description

cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
patients with active obstructive hydronephoresis
Description

obstructive hydronephoresis

Data type

boolean

Alias
UMLS CUI [1]
C0020295
patients with evidence of active infection requiring iv antibiotics at time of study entry
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
patients with new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for 5 years
Description

prior malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
patients with known hiv infection
Description

hiv

Data type

boolean

Alias
UMLS CUI [1]
C0019682
patients with known brain or leptomeningeal metasteses
Description

brain or leptomeningeal metasteses

Data type

boolean

Alias
UMLS CUI [1]
C0220650
patients who are pregnant or nursing
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Lymphoma, Non-Hodgkin NCT00938041

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
non-hodgkin's b-cell lymphoma
Item
patients with histologically confirmed initial diagnosis of non-hodgkin's b-cell lymphoma
boolean
C0024305 (UMLS CUI [1])
iodine-131
Item
patients must have previously responded with a duration of response of at least 3 months to iodine-131 anti-b1 antibody therapy
boolean
C0303029 (UMLS CUI [1])
cd20 expression
Item
patients must have evidence that their tumor tissue had cd20 expression
boolean
C0054946 (UMLS CUI [1])
karnofsky performance status and life expectancy
Item
patients must have performance status of at least 60% on the karnofsky scale and an anticipated survival of at least 3 months
boolean
C0206065 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
granulocyte and platelet count
Item
patients must have absolute granulocyte count (anc) greater than 1,500 cells/mm3 and platelet count greater than 100,000 cells/mm3 within 14 days of study entry without support of hematopoietic cytokines or transfusion of blood products
boolean
C0005821 (UMLS CUI [1])
C0857490 (UMLS CUI [2])
renal and hepatic function
Item
patients must have adequate renal (serum creatine less than 1.5 x upper limit of normal) and hepatic function (total bilirubin less than 1.5 x upper limit of normal and hepatic transaminases, ast and alt, less than 5 x upper limit of normal) within 14 days of study entry
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0002594 (UMLS CUI [3])
measurable disease
Item
patients must have bi-dimensionally measurable disease with a least one lesion greater than or equal to 2 cm x 2 cm by ct scan
boolean
C1513041 (UMLS CUI [1])
age
Item
patients must be at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
patients must give written informed consent and sign an institutional review board/ethics committee- approved informed consent form prior to study entry
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
bone marrow involvement
Item
patients with more than 25% bone marrow involvement
boolean
C1517677 (UMLS CUI [1])
cancer treatment
Item
patients who have received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or who exhibit persistent clinical evidence of toxicity. the use of systemic steroids much be discontinued at least 1 week prior to study entry.
boolean
C0920425 (UMLS CUI [1])
obstructive hydronephoresis
Item
patients with active obstructive hydronephoresis
boolean
C0020295 (UMLS CUI [1])
infection
Item
patients with evidence of active infection requiring iv antibiotics at time of study entry
boolean
C0009450 (UMLS CUI [1])
comorbidity
Item
patients with new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation
boolean
C0009488 (UMLS CUI [1])
prior malignancy
Item
patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for 5 years
boolean
C0006826 (UMLS CUI [1])
hiv
Item
patients with known hiv infection
boolean
C0019682 (UMLS CUI [1])
brain or leptomeningeal metasteses
Item
patients with known brain or leptomeningeal metasteses
boolean
C0220650 (UMLS CUI [1])
pregnancy
Item
patients who are pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
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