ID

30562

Beskrivning

Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma.; ODM derived from: https://clinicaltrials.gov/show/NCT00963534

Länk

https://clinicaltrials.gov/show/NCT00963534

Nyckelord

Versioner (1)
  1. 2018-06-14 2018-06-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 juni 2018

DOI

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Creative Commons BY 4.0
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Eligibility Mantle Cell Lymphoma NCT00963534

Engelsk

Eligibility Mantle Cell Lymphoma NCT00963534

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age over 65 years, or age under 65 years, unable to tolerate high dose chemotherapy with autologous stem cell support
Beskrivning

Age | High-dose chemotherapy Receive Unable | Autologous stem cell infusion Receive Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1328050
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C2145405
UMLS CUI [3,2]
C1514756
UMLS CUI [3,3]
C1299582
histologically confirmed mantle cell lymphoma, stage ii-iv at time of diagnosis
Beskrivning

Mantle cell lymphoma Ann Arbor lymphoma staging system

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0334634
UMLS CUI [1,2]
C0432516
no previous treatment for lymphoma except radiotherapy or one cycle of any chemotherapy regimen for lymphoma
Beskrivning

Absence Prior Therapy Lymphoma | Exception Therapeutic radiology procedure Lymphoma | Exception Chemotherapy cycle Quantity Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0024299
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0024299
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1302181
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0024299
who performance status 0-3
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
written informed concent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
female subjects of childbearing potential must agree to use and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, through study drug therapy and for 4 weeks after the end of study drug therapy
Beskrivning

Childbearing Potential Contraceptive methods | Relationship Investigational Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0949266
male subjects must agree to use condoms throughout study drug therapy if their partner is of childbearing potential, and has no contraception, and agree to not donate semen during study drug therapy and for one week after end of study drug therapy
Beskrivning

Gender Male Condom | Partner Childbearing Potential Contraceptive methods Absent | Sperm donation Absent | Relationship Investigational Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0009653
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C3831118
UMLS CUI [2,3]
C0700589
UMLS CUI [2,4]
C0332197
UMLS CUI [3,1]
C0871414
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0949266
all subjects must agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation, and agree not to share study medication with another person
Beskrivning

Blood Donation Absent | Investigational New Drugs Sharing Absent | Relationship Investigational Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0237876
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0949266
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
impaired liver function
Beskrivning

Liver Dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
anc less than 1.0 x 10 9, unless caused by bone marrow infiltration by lymphoma
Beskrivning

Absolute neutrophil count | Exception Etiology Bone marrow infiltration Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C3854434
UMLS CUI [2,4]
C0024299
platelet count less than 60 x 10 9, unless caused by bone marrow infiltration by lymphoma
Beskrivning

Platelet Count measurement | Exception Etiology Bone marrow infiltration Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C3854434
UMLS CUI [2,4]
C0024299
creatinine clearance below 50 ml/min (cockcroft formula))
Beskrivning

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1]
C2711451
known hiv positivity
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
known seropositivity for hcv, hbsag, anti-hbc, or other active infection uncontrolled by treatment
Beskrivning

Serology positive Hepatitis C virus | Serology positive Hepatitis B Surface Antigens | Serology positive Anti-HBc antibody | Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0220847
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019168
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0948759
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205318
psychiatric illness or condition which could interfere with the subject´s ability to understand the requirements of the study
Beskrivning

Mental disorders Interferes with Comprehension Study Protocol | Mental condition Interferes with Comprehension Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0162340
UMLS CUI [2,4]
C2348563
requirement of corticosteroid therapy at a dose over 10 mg prednisolone/day
Beskrivning

Patient need for Steroid therapy | Prednisolone Dose U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0149783
UMLS CUI [2,1]
C0032950
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456683
pregnant or lactating females
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Mantle Cell Lymphoma NCT00963534

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | High-dose chemotherapy Receive Unable | Autologous stem cell infusion Receive Unable
Item
age over 65 years, or age under 65 years, unable to tolerate high dose chemotherapy with autologous stem cell support
boolean
C0001779 (UMLS CUI [1])
C1328050 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C2145405 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Mantle cell lymphoma Ann Arbor lymphoma staging system
Item
histologically confirmed mantle cell lymphoma, stage ii-iv at time of diagnosis
boolean
C0334634 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Absence Prior Therapy Lymphoma | Exception Therapeutic radiology procedure Lymphoma | Exception Chemotherapy cycle Quantity Lymphoma
Item
no previous treatment for lymphoma except radiotherapy or one cycle of any chemotherapy regimen for lymphoma
boolean
C0332197 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1302181 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0024299 (UMLS CUI [3,4])
WHO performance status scale
Item
who performance status 0-3
boolean
C1298650 (UMLS CUI [1])
Informed Consent
Item
written informed concent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Relationship Investigational Therapy
Item
female subjects of childbearing potential must agree to use and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, through study drug therapy and for 4 weeks after the end of study drug therapy
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C0949266 (UMLS CUI [2,2])
Gender Male Condom | Partner Childbearing Potential Contraceptive methods Absent | Sperm donation Absent | Relationship Investigational Therapy
Item
male subjects must agree to use condoms throughout study drug therapy if their partner is of childbearing potential, and has no contraception, and agree to not donate semen during study drug therapy and for one week after end of study drug therapy
boolean
C0079399 (UMLS CUI [1,1])
C0009653 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C0871414 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0439849 (UMLS CUI [4,1])
C0949266 (UMLS CUI [4,2])
Blood Donation Absent | Investigational New Drugs Sharing Absent | Relationship Investigational Therapy
Item
all subjects must agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation, and agree not to share study medication with another person
boolean
C0005794 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C0237876 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0439849 (UMLS CUI [3,1])
C0949266 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Liver Dysfunction
Item
impaired liver function
boolean
C0086565 (UMLS CUI [1])
Absolute neutrophil count | Exception Etiology Bone marrow infiltration Lymphoma
Item
anc less than 1.0 x 10 9, unless caused by bone marrow infiltration by lymphoma
boolean
C0948762 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C3854434 (UMLS CUI [2,3])
C0024299 (UMLS CUI [2,4])
Platelet Count measurement | Exception Etiology Bone marrow infiltration Lymphoma
Item
platelet count less than 60 x 10 9, unless caused by bone marrow infiltration by lymphoma
boolean
C0032181 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C3854434 (UMLS CUI [2,3])
C0024299 (UMLS CUI [2,4])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance below 50 ml/min (cockcroft formula))
boolean
C2711451 (UMLS CUI [1])
HIV Seropositivity
Item
known hiv positivity
boolean
C0019699 (UMLS CUI [1])
Serology positive Hepatitis C virus | Serology positive Hepatitis B Surface Antigens | Serology positive Anti-HBc antibody | Communicable Disease Uncontrolled
Item
known seropositivity for hcv, hbsag, anti-hbc, or other active infection uncontrolled by treatment
boolean
C0242089 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0019168 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0948759 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Mental disorders Interferes with Comprehension Study Protocol | Mental condition Interferes with Comprehension Study Protocol
Item
psychiatric illness or condition which could interfere with the subject´s ability to understand the requirements of the study
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
Patient need for Steroid therapy | Prednisolone Dose U/day
Item
requirement of corticosteroid therapy at a dose over 10 mg prednisolone/day
boolean
C0686904 (UMLS CUI [1,1])
C0149783 (UMLS CUI [1,2])
C0032950 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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