ID

17245

Beskrivning

Zevalin-BEAM/BEAC With Autologous Stem Cell Support as Consolidation in First Line Treatment of Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00514475

Länk

https://clinicaltrials.gov/show/NCT00514475

Nyckelord

Versioner (1)
  1. 2016-09-01 2016-09-01 -
Uppladdad den

1 september 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Mantle Cell Lymphoma NCT00514475

Engelsk

Eligibility Mantle Cell Lymphoma NCT00514475

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 - 65 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. histologically confirmed (according to the who classification) mantle cell lymphoma stage ii-iv at time point of diagnosis. the diagnosis has to be confirmed by phenotypic expression of cd5, cd20 and cyclin-d1 and most cases will have t(11;14) translocation.
Beskrivning

Mantle cell lymphoma stage ii-iv, phenotypic expression of cd5, cd20 and cyclin-d1 and t(11;14) translocation in most cases

Datatyp

boolean

Alias
UMLS CUI [1]
C0334634
UMLS CUI [2]
C1300072
UMLS CUI [3]
C3538992
UMLS CUI [4]
C3540684
UMLS CUI [5]
C0174680
UMLS CUI [6]
C1515705
3. no previous treatment for lymphoma except radiotherapy or one cycle of any regimen and except patients treated in the previous phase ii study who can be transferred to nlg-mcl-iii before evaluation at week 15.
Beskrivning

no previous treatment for lymphoma except radiotherapy or one cycle of any regimen

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C0750480
4. who performance status of 0 - 3.
Beskrivning

WHO performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
5. life expectancy of more than 3 months.
Beskrivning

Life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
6. written informed consent.
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. severe cardiac disease: cardiac function grade 3-4 (appendix 1).
Beskrivning

Cardiac function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232164
2. impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment.
Beskrivning

Impaired liver, renal or other organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232164
UMLS CUI [4,1]
C1321605
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0009488
3. pregnancy/lactation
Beskrivning

Pregnancy/lactation

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. men or woman of reproductive potential not agreeing to use acceptable method of birth control during treatment and for six moths after completion of treatment.
Beskrivning

Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
5. known hiv positivity
Beskrivning

HIV

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
6. any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma.
Beskrivning

Malignancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
7. known seropositivity for hcv, hbsag or other active infection uncontrolled by treatment.
Beskrivning

Seropositivity for hcv, hbsag or other active infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C0019168
UMLS CUI [3]
C0009450
8. psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
Beskrivning

psychiatric illness

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0004936
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Similar models

Eligibility Mantle Cell Lymphoma NCT00514475

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18 - 65 years.
boolean
C0001779 (UMLS CUI [1])
Mantle cell lymphoma stage ii-iv, phenotypic expression of cd5, cd20 and cyclin-d1 and t(11;14) translocation in most cases
Item
2. histologically confirmed (according to the who classification) mantle cell lymphoma stage ii-iv at time point of diagnosis. the diagnosis has to be confirmed by phenotypic expression of cd5, cd20 and cyclin-d1 and most cases will have t(11;14) translocation.
boolean
C0334634 (UMLS CUI [1])
C1300072 (UMLS CUI [2])
C3538992 (UMLS CUI [3])
C3540684 (UMLS CUI [4])
C0174680 (UMLS CUI [5])
C1515705 (UMLS CUI [6])
no previous treatment for lymphoma except radiotherapy or one cycle of any regimen
Item
3. no previous treatment for lymphoma except radiotherapy or one cycle of any regimen and except patients treated in the previous phase ii study who can be transferred to nlg-mcl-iii before evaluation at week 15.
boolean
C1522449 (UMLS CUI [1])
C1302181 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
WHO performance status
Item
4. who performance status of 0 - 3.
boolean
C1298650 (UMLS CUI [1])
Life expectancy
Item
5. life expectancy of more than 3 months.
boolean
C0023671 (UMLS CUI [1])
Informed consent
Item
6. written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiac function
Item
1. severe cardiac disease: cardiac function grade 3-4 (appendix 1).
boolean
C0232164 (UMLS CUI [1])
Impaired liver, renal or other organ function
Item
2. impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment.
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232164 (UMLS CUI [3])
C1321605 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0009488 (UMLS CUI [4,3])
Pregnancy/lactation
Item
3. pregnancy/lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive methods
Item
4. men or woman of reproductive potential not agreeing to use acceptable method of birth control during treatment and for six moths after completion of treatment.
boolean
C0700589 (UMLS CUI [1])
HIV
Item
5. known hiv positivity
boolean
C0019699 (UMLS CUI [1])
Malignancy
Item
6. any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma.
boolean
C0006826 (UMLS CUI [1])
Seropositivity for hcv, hbsag or other active infection
Item
7. known seropositivity for hcv, hbsag or other active infection uncontrolled by treatment.
boolean
C0019196 (UMLS CUI [1])
C0019168 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
psychiatric illness
Item
8. psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
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