ID

16079

Beschreibung

Combination Antibody Therapy for Relapsed Lymphoma and Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00022971

Link

https://clinicaltrials.gov/show/NCT00022971

Stichworte

Versionen (1)
  1. 28.06.16 28.06.16 -
Hochgeladen am

28. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diffuse Large B-cell Lymphoma NCT00022971

Englisch

Eligibility Diffuse Large B-cell Lymphoma NCT00022971

1 Formulare  
Criteria
Beschreibung

Criteria

diagnosis of b-cell lymphoma, waldenstrom's cll with surface expression of both cd20 and 1d10 antigen by immunohistochemistry (ihc) or fluorescence of activated cell sorting (facs) with anti-cd20 and 1d10 antibody. positive 1d10 expression in a facs assay is defined as more than 2 times the mean fluorescence intensity (mfi) of the control antibody by facs or greater than 20% of cells 1d10+ by ihc.
Beschreibung

diagnosis of b-cell lymphoma or waldenstroms cll

Datentyp

boolean

Alias
UMLS CUI [1]
C0079731
UMLS CUI [2]
C0024419
confirmation of diagnosis in laboratory of pathology, nci or osu.
Beschreibung

confirmation of diagnosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011911
UMLS CUI [2,1]
C0348026
UMLS CUI [2,2]
C1513882
prior therapy with at least one systemic treatment, and not a candidate for potentially curative (i.e., transplant) treatment at the time of study entry. prior treatment with rituximab greater than or equal to 1 month ago is permitted.
Beschreibung

prior therapy with systemic agents or rituximab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1515119
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C4047978
age greater than 18 years.
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status less than or equal to 2.
Beschreibung

ecog performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1632812
major organ function: anc greater than or equal to 500/microliter, platelet greater than or equal 25,000/microliter, creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 60 cc/min; sgpt less than 5 x upper limit of normal; bilirubin less than 2 mg/dl (total) except less than 5 mg/dl in patients with gilbert's syndrome as defined by greater than 80% unconjugated; unless impairment due to organ involvement by lymphoma.
Beschreibung

organ function parameters

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0373595
UMLS CUI [5]
C0201836
UMLS CUI [6]
C1278039
provides informed consent.
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or nursing. both male and female patients must be willing to use adequate contraception.
Beschreibung

pregnant or nursing, willing to use contraception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0700589
prior apolizumab treatment.
Beschreibung

prior apolizumab treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1122758
sactive cardiac disease, cerebrovascular disease or peripheral arterial vascular disease.
Beschreibung

cardiac, cerebrovascular or peripheral vascular disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0007820
UMLS CUI [1,3]
C3841707
active cns lymphoma.
Beschreibung

active cns lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0742472
systemic cytotoxic chemotherapy within 3 weeks of enrollment or systemic steroids (except stable doses less than 10 mg/day) within 1 week of enrollment.
Beschreibung

chemotherapy or systemic steroid therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0149783
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Ähnliche Modelle

Eligibility Diffuse Large B-cell Lymphoma NCT00022971

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
diagnosis of b-cell lymphoma or waldenstroms cll
Item
diagnosis of b-cell lymphoma, waldenstrom's cll with surface expression of both cd20 and 1d10 antigen by immunohistochemistry (ihc) or fluorescence of activated cell sorting (facs) with anti-cd20 and 1d10 antibody. positive 1d10 expression in a facs assay is defined as more than 2 times the mean fluorescence intensity (mfi) of the control antibody by facs or greater than 20% of cells 1d10+ by ihc.
boolean
C0079731 (UMLS CUI [1])
C0024419 (UMLS CUI [2])
confirmation of diagnosis
Item
confirmation of diagnosis in laboratory of pathology, nci or osu.
boolean
C0011911 (UMLS CUI [1])
C0348026 (UMLS CUI [2,1])
C1513882 (UMLS CUI [2,2])
prior therapy with systemic agents or rituximab
Item
prior therapy with at least one systemic treatment, and not a candidate for potentially curative (i.e., transplant) treatment at the time of study entry. prior treatment with rituximab greater than or equal to 1 month ago is permitted.
boolean
C1514463 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C4047978 (UMLS CUI [2,2])
age
Item
age greater than 18 years.
boolean
C0001779 (UMLS CUI [1])
ecog performance status
Item
ecog performance status less than or equal to 2.
boolean
C1632812 (UMLS CUI [1])
organ function parameters
Item
major organ function: anc greater than or equal to 500/microliter, platelet greater than or equal 25,000/microliter, creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 60 cc/min; sgpt less than 5 x upper limit of normal; bilirubin less than 2 mg/dl (total) except less than 5 mg/dl in patients with gilbert's syndrome as defined by greater than 80% unconjugated; unless impairment due to organ involvement by lymphoma.
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
informed consent
Item
provides informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnant or nursing, willing to use contraception
Item
pregnancy or nursing. both male and female patients must be willing to use adequate contraception.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
prior apolizumab treatment
Item
prior apolizumab treatment.
boolean
C1514463 (UMLS CUI [1,1])
C1122758 (UMLS CUI [1,2])
cardiac, cerebrovascular or peripheral vascular disease
Item
sactive cardiac disease, cerebrovascular disease or peripheral arterial vascular disease.
boolean
C0007222 (UMLS CUI [1,1])
C0007820 (UMLS CUI [1,2])
C3841707 (UMLS CUI [1,3])
active cns lymphoma
Item
active cns lymphoma.
boolean
C0742472 (UMLS CUI [1])
chemotherapy or systemic steroid therapy
Item
systemic cytotoxic chemotherapy within 3 weeks of enrollment or systemic steroids (except stable doses less than 10 mg/day) within 1 week of enrollment.
boolean
C0392920 (UMLS CUI [1])
C0149783 (UMLS CUI [2])
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