ID

30367

Beschrijving

Two Different Methods of Collecting Stem Cells For an Autologous Stem Cell Transplant in Treating Patients With Diffuse Large Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00566228

Link

https://clinicaltrials.gov/show/NCT00566228

Trefwoorden

Versies (2)
  1. 30-05-18 30-05-18 -
  2. 30-05-18 30-05-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

30 mei 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00566228

Engels

Eligibility Lymphoma NCT00566228

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00566228
Criteria
Beschrijving

Criteria

diagnosis of diffuse large cell lymphoma
Beschrijving

Diffuse Large B-Cell Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0079744
low-grade non-hodgkin lymphoma transformed to diffuse large cell lymphoma allowed
Beschrijving

Non-Hodgkin Lymphoma low grade | Transformation Diffuse Large B-Cell Lymphoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C1282907
UMLS CUI [2,1]
C1510411
UMLS CUI [2,2]
C0079744
candidate for with autologous peripheral blood stem cell transplantation
Beschrijving

Patient Appropriate Peripheral Stem Cell Transplantation Autologous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0242602
UMLS CUI [1,4]
C0439859
not requiring bone marrow harvest to collect stem cells
Beschrijving

Absence Requirement Bone marrow harvest | Stem Cell Collection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0194015
UMLS CUI [2]
C3827940
no chemotherapy with filgrastim ( g-csf) or mobilization study drug (i.e., amd3100) needed for mobilization of stem cells
Beschrijving

Exclusion Criteria | Filgrastim | Mobilization Investigational New Drugs | Other Coding | Requirement Mobilization Stem cells

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0210630
UMLS CUI [3,1]
C0300926
UMLS CUI [3,2]
C0013230
UMLS CUI [4]
C3846158
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0300926
UMLS CUI [5,3]
C0038250
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
cardiac and pulmonary status sufficient to undergo apheresis and stem cell transplantation
Beschrijving

Cardiac function Sufficient Apheresis | Pulmonary function Sufficient Apheresis | Cardiac function Sufficient Stem cell transplant | Pulmonary function Sufficient Stem cell transplant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232164
UMLS CUI [1,2]
C0205410
UMLS CUI [1,3]
C0005791
UMLS CUI [2,1]
C0231921
UMLS CUI [2,2]
C0205410
UMLS CUI [2,3]
C0005791
UMLS CUI [3,1]
C0232164
UMLS CUI [3,2]
C0205410
UMLS CUI [3,3]
C1504389
UMLS CUI [4,1]
C0231921
UMLS CUI [4,2]
C0205410
UMLS CUI [4,3]
C1504389
negative pregnancy test
Beschrijving

Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
not pregnant or nursing
Beschrijving

Pregnancy Absent | Breast Feeding Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
fertile patients must use effective contraception
Beschrijving

Fertility Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
hiv negative
Beschrijving

HIV negative

Datatype

boolean

Alias
UMLS CUI [1]
C0481430
no active uncontrolled infection requiring antibiotic treatment
Beschrijving

Exclusion | Communicable Disease Uncontrolled Requirement Antibiotic therapy

Datatype

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0338237
no comorbid condition which, in view of the investigators, renders the patient at high risk from treatment complications
Beschrijving

Exclusion | Comorbidity High risk Complications of treatment

Datatype

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0332167
UMLS CUI [2,3]
C0679861
willing to provide all research blood samples as required by the protocol
Beschrijving

Blood specimen Provide

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C1999230
prior concurrent therapy:
Beschrijving

Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
at least 4 weeks since prior chemotherapy (rituxan is not considered chemotherapy for the purpose of this study)
Beschrijving

Prior Chemotherapy | Exception Rituxan

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0732355
more than 4 weeks since prior experimental therapy
Beschrijving

Investigational Therapy Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0949266
UMLS CUI [1,2]
C0205156
no concurrent enrollment on another experimental protocol during the mobilization phase
Beschrijving

Exclusion Criteria | Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C2348568
no concurrent participation in any autologous stem cell transplantation study that is not using the standard conditioning regimens for lymphomas
Beschrijving

Exclusion Criteria | Study Subject Participation Status | Transplantation of autologous hematopoietic stem cell | Absence Standard of Care Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C2348568
UMLS CUI [3]
C1831743
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C2936643
UMLS CUI [4,3]
C0024299
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Similar models

Eligibility Lymphoma NCT00566228

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00566228
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Diffuse Large B-Cell Lymphoma
Item
diagnosis of diffuse large cell lymphoma
boolean
C0079744 (UMLS CUI [1])
Non-Hodgkin Lymphoma low grade | Transformation Diffuse Large B-Cell Lymphoma
Item
low-grade non-hodgkin lymphoma transformed to diffuse large cell lymphoma allowed
boolean
C0024305 (UMLS CUI [1,1])
C1282907 (UMLS CUI [1,2])
C1510411 (UMLS CUI [2,1])
C0079744 (UMLS CUI [2,2])
Patient Appropriate Peripheral Stem Cell Transplantation Autologous
Item
candidate for with autologous peripheral blood stem cell transplantation
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0242602 (UMLS CUI [1,3])
C0439859 (UMLS CUI [1,4])
Absence Requirement Bone marrow harvest | Stem Cell Collection
Item
not requiring bone marrow harvest to collect stem cells
boolean
C0332197 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0194015 (UMLS CUI [1,3])
C3827940 (UMLS CUI [2])
Exclusion Criteria | Filgrastim | Mobilization Investigational New Drugs | Other Coding | Requirement Mobilization Stem cells
Item
no chemotherapy with filgrastim ( g-csf) or mobilization study drug (i.e., amd3100) needed for mobilization of stem cells
boolean
C0680251 (UMLS CUI [1])
C0210630 (UMLS CUI [2])
C0300926 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C3846158 (UMLS CUI [4])
C1514873 (UMLS CUI [5,1])
C0300926 (UMLS CUI [5,2])
C0038250 (UMLS CUI [5,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Cardiac function Sufficient Apheresis | Pulmonary function Sufficient Apheresis | Cardiac function Sufficient Stem cell transplant | Pulmonary function Sufficient Stem cell transplant
Item
cardiac and pulmonary status sufficient to undergo apheresis and stem cell transplantation
boolean
C0232164 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0005791 (UMLS CUI [1,3])
C0231921 (UMLS CUI [2,1])
C0205410 (UMLS CUI [2,2])
C0005791 (UMLS CUI [2,3])
C0232164 (UMLS CUI [3,1])
C0205410 (UMLS CUI [3,2])
C1504389 (UMLS CUI [3,3])
C0231921 (UMLS CUI [4,1])
C0205410 (UMLS CUI [4,2])
C1504389 (UMLS CUI [4,3])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
HIV negative
Item
hiv negative
boolean
C0481430 (UMLS CUI [1])
Exclusion | Communicable Disease Uncontrolled Requirement Antibiotic therapy
Item
no active uncontrolled infection requiring antibiotic treatment
boolean
C2828389 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0338237 (UMLS CUI [2,4])
Exclusion | Comorbidity High risk Complications of treatment
Item
no comorbid condition which, in view of the investigators, renders the patient at high risk from treatment complications
boolean
C2828389 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C0679861 (UMLS CUI [2,3])
Blood specimen Provide
Item
willing to provide all research blood samples as required by the protocol
boolean
C0178913 (UMLS CUI [1,1])
C1999230 (UMLS CUI [1,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Prior Chemotherapy | Exception Rituxan
Item
at least 4 weeks since prior chemotherapy (rituxan is not considered chemotherapy for the purpose of this study)
boolean
C1514457 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0732355 (UMLS CUI [2,2])
Investigational Therapy Previous
Item
more than 4 weeks since prior experimental therapy
boolean
C0949266 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Exclusion Criteria | Study Subject Participation Status
Item
no concurrent enrollment on another experimental protocol during the mobilization phase
boolean
C0680251 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Exclusion Criteria | Study Subject Participation Status | Transplantation of autologous hematopoietic stem cell | Absence Standard of Care Lymphoma
Item
no concurrent participation in any autologous stem cell transplantation study that is not using the standard conditioning regimens for lymphomas
boolean
C0680251 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C1831743 (UMLS CUI [3])
C0332197 (UMLS CUI [4,1])
C2936643 (UMLS CUI [4,2])
C0024299 (UMLS CUI [4,3])
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