ID

13207

Description

Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00183989

Link

https://clinicaltrials.gov/show/NCT00183989

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 NCT00183989

English

Eligibility Mantle Cell Lymphoma NCT00183989

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologic diagnosis of non-hodgkin's lymphoma of the mantle cell sub-type lymphoma only, as determined by morphologic assessment and consistent immunophemotypic markers
Description

pathology mantle cell lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0030664
UMLS CUI [1,2]
C0334634
newly diagnosed and patients who have received prior treatment are eligible
Description

diagnosis, treatment

Data type

boolean

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C0087111
measurable or evaluable disease
Description

measurable or evaluable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
karnofsky performance status greater or equal to 50%
Description

karnofsky

Data type

boolean

Alias
UMLS CUI [1]
C0206065
men and women, age greater or equal to 18 years old
Description

gender, age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
agc greater or equal to 1.0; platelets greater or equal to 75,000; hemoglobin greater or equal to 8.0 (unless because of lymphomatous infiltration of the marrow)
Description

granulocytes, platelets, hb

Data type

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
creatinine less than 2.0; bilirubin less than 2.0; sgot less than 3 times upper limit of normal (unless elevations are due to lymphomatous involvement)
Description

creatinine, bilirubin, ast

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
women of child bearing potential must have negative pregnancy test within 14 days of study entry.
Description

pregnancy tes

Data type

boolean

Alias
UMLS CUI [1]
C0032976
signed informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of congestive heart failure or significant cardiac disease
Description

cardiac disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
prior exposure to either fludarabine or mitoxantrone. prior exposure to rituximab allowed
Description

fludarabine, mitoxantrone

Data type

boolean

Alias
UMLS CUI [1]
C0059985
UMLS CUI [2]
C0026259
active infection
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
hiv seropositive
Description

hiv

Data type

boolean

Alias
UMLS CUI [1]
C0019682
pregnant or lactating females
Description

pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
second active malignancy, other than squamous cell skin cancer,in-situ cervical cancer, or history of other cancer diagnosed within the preceding 5 years
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
presence of psychological or emotional disorders which would make valid informed consent impossible
Description

mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0004936
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Similar models

Eligibility Mantle Cell Lymphoma NCT00183989

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
pathology mantle cell lymphoma
Item
pathologic diagnosis of non-hodgkin's lymphoma of the mantle cell sub-type lymphoma only, as determined by morphologic assessment and consistent immunophemotypic markers
boolean
C0030664 (UMLS CUI [1,1])
C0334634 (UMLS CUI [1,2])
diagnosis, treatment
Item
newly diagnosed and patients who have received prior treatment are eligible
boolean
C0011900 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
measurable or evaluable disease
Item
measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
karnofsky
Item
karnofsky performance status greater or equal to 50%
boolean
C0206065 (UMLS CUI [1])
gender, age
Item
men and women, age greater or equal to 18 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
granulocytes, platelets, hb
Item
agc greater or equal to 1.0; platelets greater or equal to 75,000; hemoglobin greater or equal to 8.0 (unless because of lymphomatous infiltration of the marrow)
boolean
C0857490 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
creatinine, bilirubin, ast
Item
creatinine less than 2.0; bilirubin less than 2.0; sgot less than 3 times upper limit of normal (unless elevations are due to lymphomatous involvement)
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
pregnancy tes
Item
women of child bearing potential must have negative pregnancy test within 14 days of study entry.
boolean
C0032976 (UMLS CUI [1])
informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
cardiac disease
Item
history of congestive heart failure or significant cardiac disease
boolean
C0018799 (UMLS CUI [1])
fludarabine, mitoxantrone
Item
prior exposure to either fludarabine or mitoxantrone. prior exposure to rituximab allowed
boolean
C0059985 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
infection
Item
active infection
boolean
C0009450 (UMLS CUI [1])
hiv
Item
hiv seropositive
boolean
C0019682 (UMLS CUI [1])
pregnant or lactating
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
malignancy
Item
second active malignancy, other than squamous cell skin cancer,in-situ cervical cancer, or history of other cancer diagnosed within the preceding 5 years
boolean
C0006826 (UMLS CUI [1])
mental disorders
Item
presence of psychological or emotional disorders which would make valid informed consent impossible
boolean
C0004936 (UMLS CUI [1])
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