ID

39085

Beskrivning

Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01499303

Länk

https://clinicaltrials.gov/show/NCT01499303

Nyckelord

Versioner (1)
  1. 2019-11-29 2019-11-29 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

29 november 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diffuse Large B-Cell Lymphoma NCT01499303

Engelsk

Eligibility Diffuse Large B-Cell Lymphoma NCT01499303

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged at least 18 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patients with relapsed or refractory diffuse large b-cell lymphoma who have previously received r-chop (or equivalent) chemo-immunotherapy and high dose chemotherapy with stem cell rescue, or who are ineligible for high dose therapy with stem cell rescue.
Beskrivning

Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory | R-CHOP Regimen | Equivalent | High-Dose Chemotherapy with Autologous Stem Cell Transplant | Patients Ineligible High-Dose Chemotherapy with Autologous Stem Cell Transplant

Datatyp

boolean

Alias
UMLS CUI [1]
C0855111
UMLS CUI [2]
C0855112
UMLS CUI [3]
C0393023
UMLS CUI [4]
C0205163
UMLS CUI [5]
C1512429
UMLS CUI [6,1]
C0030705
UMLS CUI [6,2]
C1512714
UMLS CUI [6,3]
C1512429
measurable disease as defined by cheson et al 2007 criteria.
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
one fresh pre-treatment excisional or core needle biopsy from suitable and accessible site.
Beskrivning

Pre treatment Excision biopsy Site Suitable | Pre treatment Core needle biopsy Site Suitable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2709094
UMLS CUI [1,2]
C0184921
UMLS CUI [1,3]
C1515974
UMLS CUI [1,4]
C3900053
UMLS CUI [2,1]
C2709094
UMLS CUI [2,2]
C1318309
UMLS CUI [2,3]
C1515974
UMLS CUI [2,4]
C3900053
world health organization (who) performance status 0 to 1.
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with nitrosurea, mitomycin c, investigational agents or study drugs w/in28 days of first dose of study treatment, any other chemotherapy, immunotherapy or anticancer agents w/in 3 weeks of first dose of study treatment, previous fostamatinib.
Beskrivning

Nitrosourea | Mitomycin | Investigational New Drugs | Chemotherapy | Immunotherapy | Antineoplastic Agents | fostamatinib

Datatyp

boolean

Alias
UMLS CUI [1]
C0028210
UMLS CUI [2]
C0002475
UMLS CUI [3]
C0013230
UMLS CUI [4]
C0392920
UMLS CUI [5]
C0021083
UMLS CUI [6]
C0003392
UMLS CUI [7]
C2713632
with the exception of alopecia, any unresolved toxicities from prior therapy or surgery greater than common terminology criteria for adverse events (ctcae) grade 1.
Beskrivning

Exception Alopecia | Prior Therapy Resulting in Toxicity CTCAE Grades | Operative Surgical Procedures Resulting in Toxicity CTCAE Grades | Resolution Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0002170
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0600688
UMLS CUI [2,4]
C1516728
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0332294
UMLS CUI [3,3]
C0600688
UMLS CUI [3,4]
C1516728
UMLS CUI [4,1]
C1514893
UMLS CUI [4,2]
C0332268
uncontrolled hypertension (defined as >140mmhg systolic and/or > 90 mmhg diastolic at baseline with or without antihypertensive therapy.
Beskrivning

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy | Antihypertensive therapy Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4]
C0585941
UMLS CUI [5,1]
C0585941
UMLS CUI [5,2]
C0332197
evidence of tuberculosis (tb).
Beskrivning

Tuberculosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0041296
inadequate boen marrow reserve.
Beskrivning

Few mature neutrophils in the bone marrow

Datatyp

boolean

Alias
UMLS CUI [1]
C2748959
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Similar models

Eligibility Diffuse Large B-Cell Lymphoma NCT01499303

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory | R-CHOP Regimen | Equivalent | High-Dose Chemotherapy with Autologous Stem Cell Transplant | Patients Ineligible High-Dose Chemotherapy with Autologous Stem Cell Transplant
Item
patients with relapsed or refractory diffuse large b-cell lymphoma who have previously received r-chop (or equivalent) chemo-immunotherapy and high dose chemotherapy with stem cell rescue, or who are ineligible for high dose therapy with stem cell rescue.
boolean
C0855111 (UMLS CUI [1])
C0855112 (UMLS CUI [2])
C0393023 (UMLS CUI [3])
C0205163 (UMLS CUI [4])
C1512429 (UMLS CUI [5])
C0030705 (UMLS CUI [6,1])
C1512714 (UMLS CUI [6,2])
C1512429 (UMLS CUI [6,3])
Measurable Disease
Item
measurable disease as defined by cheson et al 2007 criteria.
boolean
C1513041 (UMLS CUI [1])
Pre treatment Excision biopsy Site Suitable | Pre treatment Core needle biopsy Site Suitable
Item
one fresh pre-treatment excisional or core needle biopsy from suitable and accessible site.
boolean
C2709094 (UMLS CUI [1,1])
C0184921 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C3900053 (UMLS CUI [1,4])
C2709094 (UMLS CUI [2,1])
C1318309 (UMLS CUI [2,2])
C1515974 (UMLS CUI [2,3])
C3900053 (UMLS CUI [2,4])
WHO performance status scale
Item
world health organization (who) performance status 0 to 1.
boolean
C1298650 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Nitrosourea | Mitomycin | Investigational New Drugs | Chemotherapy | Immunotherapy | Antineoplastic Agents | fostamatinib
Item
treatment with nitrosurea, mitomycin c, investigational agents or study drugs w/in28 days of first dose of study treatment, any other chemotherapy, immunotherapy or anticancer agents w/in 3 weeks of first dose of study treatment, previous fostamatinib.
boolean
C0028210 (UMLS CUI [1])
C0002475 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C0003392 (UMLS CUI [6])
C2713632 (UMLS CUI [7])
Exception Alopecia | Prior Therapy Resulting in Toxicity CTCAE Grades | Operative Surgical Procedures Resulting in Toxicity CTCAE Grades | Resolution Lacking
Item
with the exception of alopecia, any unresolved toxicities from prior therapy or surgery greater than common terminology criteria for adverse events (ctcae) grade 1.
boolean
C1705847 (UMLS CUI [1,1])
C0002170 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0600688 (UMLS CUI [2,3])
C1516728 (UMLS CUI [2,4])
C0543467 (UMLS CUI [3,1])
C0332294 (UMLS CUI [3,2])
C0600688 (UMLS CUI [3,3])
C1516728 (UMLS CUI [3,4])
C1514893 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy | Antihypertensive therapy Absent
Item
uncontrolled hypertension (defined as >140mmhg systolic and/or > 90 mmhg diastolic at baseline with or without antihypertensive therapy.
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0585941 (UMLS CUI [4])
C0585941 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Tuberculosis
Item
evidence of tuberculosis (tb).
boolean
C0041296 (UMLS CUI [1])
Few mature neutrophils in the bone marrow
Item
inadequate boen marrow reserve.
boolean
C2748959 (UMLS CUI [1])
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