ID

18419

Description

Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00151281

Link

https://clinicaltrials.gov/show/NCT00151281

Keywords

Versions (1)
  1. 11/4/16 11/4/16 -
Uploaded on

November 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Hodgkin's Lymphoma NCT00151281

English

Eligibility Non-Hodgkin's Lymphoma NCT00151281

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed diagnosis of mantle cell non-hodgkin's lymphoma with characteristic immunophenotypic profiles: cd5(+),cd23(-), cd19(+) or cd20(+), cyclin d1(+), and cd10(-)
Description

Mantle cell lymphoma | Immunophenotyping | Cell positive for CD5 antigen | CD23 Antigen Negative | Cell positive for CD19 antigen | Cell positive for CD20 antigen | Cyclin D1 Positive | CD10 antigen Negative

Data type

boolean

Alias
UMLS CUI [1]
C0334634
UMLS CUI [2]
C0079611
UMLS CUI [3]
C0882892
UMLS CUI [4,1]
C0123242
UMLS CUI [4,2]
C1513916
UMLS CUI [5]
C0882808
UMLS CUI [6]
C0882818
UMLS CUI [7,1]
C0174680
UMLS CUI [7,2]
C1514241
UMLS CUI [8,1]
C0025250
UMLS CUI [8,2]
C1513916
patient has persistent / recurrent disease after standard chemotherapy
Description

Chemotherapy | Persistent Disease | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C2983415
UMLS CUI [3]
C0277556
patient has not received either standard or investigational drugs within the last 3 weeks
Description

Pharmaceutical Preparations | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0013230
available frozen tumor tissue obtained since completion of last prior therapy (rebiopsy if needed)
Description

Tumor tissue Frozen Available | Prior Therapy Completed | Biopsy second

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0016701
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C0205436
patient has measurable disease as defined by a tumor mass > 1.5 cm in one dimension
Description

Measurable Disease | Tumor Mass Size Linear

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C3273930
UMLS CUI [2,2]
C0475440
UMLS CUI [2,3]
C0205132
age > 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
absolute granulocyte count > 1000 cells/mm3
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > 50,000 cells/mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
creatinine < 2.0 x uln
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
total bilirubin < 2.0 x uln
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
patient has kps > 50%
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
patient agrees to use birth control if of reproductive potential
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known central nervous system (cns) involvement by lymphoma
Description

Lymphoma CNS involvement

Data type

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0449389
known hiv disease
Description

HIV

Data type

boolean

Alias
UMLS CUI [1]
C0019682
known peripheral neuropathy > grade 2
Description

Peripheral Neuropathy | CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
patient is pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient has had major surgery within the last 3 weeks
Description

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
patient is receiving other investigational drugs
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Non-Hodgkin's Lymphoma NCT00151281

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Mantle cell lymphoma | Immunophenotyping | Cell positive for CD5 antigen | CD23 Antigen Negative | Cell positive for CD19 antigen | Cell positive for CD20 antigen | Cyclin D1 Positive | CD10 antigen Negative
Item
histologically confirmed diagnosis of mantle cell non-hodgkin's lymphoma with characteristic immunophenotypic profiles: cd5(+),cd23(-), cd19(+) or cd20(+), cyclin d1(+), and cd10(-)
boolean
C0334634 (UMLS CUI [1])
C0079611 (UMLS CUI [2])
C0882892 (UMLS CUI [3])
C0123242 (UMLS CUI [4,1])
C1513916 (UMLS CUI [4,2])
C0882808 (UMLS CUI [5])
C0882818 (UMLS CUI [6])
C0174680 (UMLS CUI [7,1])
C1514241 (UMLS CUI [7,2])
C0025250 (UMLS CUI [8,1])
C1513916 (UMLS CUI [8,2])
Chemotherapy | Persistent Disease | Recurrent disease
Item
patient has persistent / recurrent disease after standard chemotherapy
boolean
C0392920 (UMLS CUI [1])
C2983415 (UMLS CUI [2])
C0277556 (UMLS CUI [3])
Pharmaceutical Preparations | Investigational New Drugs
Item
patient has not received either standard or investigational drugs within the last 3 weeks
boolean
C0013227 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Tumor tissue Frozen Available | Prior Therapy Completed | Biopsy second
Item
available frozen tumor tissue obtained since completion of last prior therapy (rebiopsy if needed)
boolean
C0475358 (UMLS CUI [1,1])
C0016701 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0005558 (UMLS CUI [3,1])
C0205436 (UMLS CUI [3,2])
Measurable Disease | Tumor Mass Size Linear
Item
patient has measurable disease as defined by a tumor mass > 1.5 cm in one dimension
boolean
C1513041 (UMLS CUI [1])
C3273930 (UMLS CUI [2,1])
C0475440 (UMLS CUI [2,2])
C0205132 (UMLS CUI [2,3])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute granulocyte count > 1000 cells/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 50,000 cells/mm3
boolean
C0032181 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine < 2.0 x uln
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin < 2.0 x uln
boolean
C1278039 (UMLS CUI [1])
Karnofsky Performance Status
Item
patient has kps > 50%
boolean
C0206065 (UMLS CUI [1])
Fertility Contraceptive methods
Item
patient agrees to use birth control if of reproductive potential
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Lymphoma CNS involvement
Item
known central nervous system (cns) involvement by lymphoma
boolean
C0024299 (UMLS CUI [1,1])
C0449389 (UMLS CUI [1,2])
HIV
Item
known hiv disease
boolean
C0019682 (UMLS CUI [1])
Peripheral Neuropathy | CTCAE Grades
Item
known peripheral neuropathy > grade 2
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
patient is pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
major surgery
Item
patient has had major surgery within the last 3 weeks
boolean
C0679637 (UMLS CUI [1])
Investigational New Drugs
Item
patient is receiving other investigational drugs
boolean
C0013230 (UMLS CUI [1])
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