ID

13206

Description

Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00005780

Link

https://clinicaltrials.gov/show/NCT00005780

Keywords

Versions (1)
  1. 1/24/16 1/24/16 -
Uploaded on

January 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Mantle Cell Lymphoma NCT00005780

English

Eligibility Mantle Cell Lymphoma NCT00005780

1 forms  
Criteria
Description

Criteria

tissue diagnosis of mantle cell lymphoma (confirmed in laboratory of pathology). blastic cell variant will be eligible.
Description

mantle cell lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0030664
UMLS CUI [1,2]
C0334634
age greater than or equal to 18.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
previously untreated with cytotoxic chemotherapy. patients may have received local radiation or a short course of steroids for control of symptoms.
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
all stages of disease.
Description

disease stage

Data type

boolean

Alias
UMLS CUI [1]
C0699749
lymph node of greater than or equal to 2 cm accessible for biopsy/harvest or greater than 1000/microliters of circulating tumor cells in the blood.
Description

lymph nodes, circulating tumor cells

Data type

boolean

Alias
UMLS CUI [1]
C0024204
UMLS CUI [2]
C3272887
ecog performance status of less than or equal to 3.
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate major organ function (serum creatinine 1.5 mg/dl or creatinine clearance greater than 60 ml/min; 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; anc greater than 1000 and platelets greater than 100,000) unless impairment due to organ involvement by lymphoma.
Description

organ function

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0032181
no active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year. if muga is obtained, the lvef should exceed 40%.
Description

cardiac disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
ability to give informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
antibodies to hiv or presence of hepatitis b surface antigen.
Description

hiv, hepatitis b

Data type

boolean

Alias
UMLS CUI [1]
C0019683
UMLS CUI [2]
C0019168
pregnant or lactating.
Description

pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior malignancy in past 5 years except squamous or basal cell carcinoma or curatively treated in situ of the cervix.
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
involvement of central nervous system by lymphoma.
Description

cns involvement

Data type

boolean

Alias
UMLS CUI [1]
C0449389
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Similar models

Eligibility Mantle Cell Lymphoma NCT00005780

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
mantle cell lymphoma
Item
tissue diagnosis of mantle cell lymphoma (confirmed in laboratory of pathology). blastic cell variant will be eligible.
boolean
C0030664 (UMLS CUI [1,1])
C0334634 (UMLS CUI [1,2])
age
Item
age greater than or equal to 18.
boolean
C0001779 (UMLS CUI [1])
chemotherapy
Item
previously untreated with cytotoxic chemotherapy. patients may have received local radiation or a short course of steroids for control of symptoms.
boolean
C0392920 (UMLS CUI [1])
disease stage
Item
all stages of disease.
boolean
C0699749 (UMLS CUI [1])
lymph nodes, circulating tumor cells
Item
lymph node of greater than or equal to 2 cm accessible for biopsy/harvest or greater than 1000/microliters of circulating tumor cells in the blood.
boolean
C0024204 (UMLS CUI [1])
C3272887 (UMLS CUI [2])
ecog
Item
ecog performance status of less than or equal to 3.
boolean
C1520224 (UMLS CUI [1])
organ function
Item
adequate major organ function (serum creatinine 1.5 mg/dl or creatinine clearance greater than 60 ml/min; 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; anc greater than 1000 and platelets greater than 100,000) unless impairment due to organ involvement by lymphoma.
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
cardiac disease
Item
no active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year. if muga is obtained, the lvef should exceed 40%.
boolean
C0018799 (UMLS CUI [1])
informed consent
Item
ability to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hiv, hepatitis b
Item
antibodies to hiv or presence of hepatitis b surface antigen.
boolean
C0019683 (UMLS CUI [1])
C0019168 (UMLS CUI [2])
pregnant or lactating
Item
pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
malignancy
Item
prior malignancy in past 5 years except squamous or basal cell carcinoma or curatively treated in situ of the cervix.
boolean
C0006826 (UMLS CUI [1])
cns involvement
Item
involvement of central nervous system by lymphoma.
boolean
C0449389 (UMLS CUI [1])
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