ID

31765

Beskrivning

Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00963105

Länk

https://clinicaltrials.gov/show/NCT00963105

Nyckelord

Versioner (1)
  1. 2018-09-26 2018-09-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 september 2018

DOI

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Creative Commons BY 4.0
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Eligibility Relapsed or Refractory Chronic Lymphocytic Leukemia NCT00963105

Engelsk

Eligibility Relapsed or Refractory Chronic Lymphocytic Leukemia NCT00963105

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years at the time of signing the informed consent form
Beskrivning

Age | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
must be able to adhere to the study visit schedule and other protocol requirements
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
must have a documented diagnosis of b-cell cll
Beskrivning

B-cell CLL

Datatyp

boolean

Alias
UMLS CUI [1]
C0023434
must be relapsed or refractory to at least 1 regimen for treatment of cll . at least one of the prior treatments must have included a purine analog-based or bendamustine-based regimen
Beskrivning

Recurrent disease | Refractory Disease | Therapeutic procedure Quantity CLL | Therapeutic procedure Quantity Purine analog Based | Therapeutic procedure Quantity Bendamustine Based

Datatyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0023434
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C1268902
UMLS CUI [4,4]
C1705938
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0525079
UMLS CUI [5,4]
C1705938
must have an eastern cooperative oncology group (ecog) performance status score of
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
Beskrivning

Medical condition Serious Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorder Preventing Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0021430
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0021430
active infections requiring systemic antibiotics
Beskrivning

Communicable Diseases Requirement Antibiotics for systemic use

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3540704
systemic treatment for b-cell cll within 28 days of initiation of lenalidomide treatment
Beskrivning

Systemic therapy B-cell CLL

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0023434
alemtuzumab therapy within 120 days of initiating lenalidomide treatment
Beskrivning

alemtuzumab

Datatyp

boolean

Alias
UMLS CUI [1]
C0383429
prior therapy with lenalidomide
Beskrivning

Prior Therapy Lenalidomide

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1144149
history of grade 4 rash due to prior thalidomide treatment
Beskrivning

Rash CTCAE Grades Thalidomide Induced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C1516728
UMLS CUI [1,3]
C0039736
UMLS CUI [1,4]
C0205263
planned autologous or allogeneic bone marrow transplantation
Beskrivning

Autologous bone marrow transplant Planned | Allogeneic bone marrow transplantation Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0194037
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0149615
UMLS CUI [2,2]
C1301732
central nervous system (cns) involvement as documented by spinal fluid cytology or imaging.
Beskrivning

Central Nervous System Involvement Cerebrospinal fluid smear with cytology | Central Nervous System Involvement Imaging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C2702977
UMLS CUI [2,1]
C4050309
UMLS CUI [2,2]
C0011923
uncontrolled hyperthyroidism or hypothyroidism
Beskrivning

Hyperthyroidism Uncontrolled | Hypothyroidism Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020550
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0020676
UMLS CUI [2,2]
C0205318
venous thromboembolism within 12 months
Beskrivning

Venous Thromboembolism

Datatyp

boolean

Alias
UMLS CUI [1]
C1861172
≥ grade-2 neuropathy
Beskrivning

Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
uncontrolled autoimmune hemolytic anemia or thrombocytopenia
Beskrivning

Autoimmune hemolytic anemia Uncontrolled | Thrombocytopenia Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002880
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0040034
UMLS CUI [2,2]
C0205318
disease transformation [i.e. richter's syndrome (lymphomas) or prolymphocytic leukemia]
Beskrivning

Disease Transformation | Richter's syndrome | Prolymphocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C4055129
UMLS CUI [2]
C0349631
UMLS CUI [3]
C0023486
participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy
Beskrivning

Study Subject Participation Status | Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
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Similar models

Eligibility Relapsed or Refractory Chronic Lymphocytic Leukemia NCT00963105

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
age ≥ 18 years at the time of signing the informed consent form
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Protocol Compliance
Item
must be able to adhere to the study visit schedule and other protocol requirements
boolean
C0525058 (UMLS CUI [1])
B-cell CLL
Item
must have a documented diagnosis of b-cell cll
boolean
C0023434 (UMLS CUI [1])
Recurrent disease | Refractory Disease | Therapeutic procedure Quantity CLL | Therapeutic procedure Quantity Purine analog Based | Therapeutic procedure Quantity Bendamustine Based
Item
must be relapsed or refractory to at least 1 regimen for treatment of cll . at least one of the prior treatments must have included a purine analog-based or bendamustine-based regimen
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0023434 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1268902 (UMLS CUI [4,3])
C1705938 (UMLS CUI [4,4])
C0087111 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0525079 (UMLS CUI [5,3])
C1705938 (UMLS CUI [5,4])
ECOG performance status
Item
must have an eastern cooperative oncology group (ecog) performance status score of
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical condition Serious Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorder Preventing Informed Consent
Item
any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0438215 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
Communicable Diseases Requirement Antibiotics for systemic use
Item
active infections requiring systemic antibiotics
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3540704 (UMLS CUI [1,3])
Systemic therapy B-cell CLL
Item
systemic treatment for b-cell cll within 28 days of initiation of lenalidomide treatment
boolean
C1515119 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
alemtuzumab
Item
alemtuzumab therapy within 120 days of initiating lenalidomide treatment
boolean
C0383429 (UMLS CUI [1])
Prior Therapy Lenalidomide
Item
prior therapy with lenalidomide
boolean
C1514463 (UMLS CUI [1,1])
C1144149 (UMLS CUI [1,2])
Rash CTCAE Grades Thalidomide Induced
Item
history of grade 4 rash due to prior thalidomide treatment
boolean
C0015230 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0039736 (UMLS CUI [1,3])
C0205263 (UMLS CUI [1,4])
Autologous bone marrow transplant Planned | Allogeneic bone marrow transplantation Planned
Item
planned autologous or allogeneic bone marrow transplantation
boolean
C0194037 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0149615 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Central Nervous System Involvement Cerebrospinal fluid smear with cytology | Central Nervous System Involvement Imaging
Item
central nervous system (cns) involvement as documented by spinal fluid cytology or imaging.
boolean
C4050309 (UMLS CUI [1,1])
C2702977 (UMLS CUI [1,2])
C4050309 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
Hyperthyroidism Uncontrolled | Hypothyroidism Uncontrolled
Item
uncontrolled hyperthyroidism or hypothyroidism
boolean
C0020550 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0020676 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Venous Thromboembolism
Item
venous thromboembolism within 12 months
boolean
C1861172 (UMLS CUI [1])
Neuropathy CTCAE Grades
Item
≥ grade-2 neuropathy
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Autoimmune hemolytic anemia Uncontrolled | Thrombocytopenia Uncontrolled
Item
uncontrolled autoimmune hemolytic anemia or thrombocytopenia
boolean
C0002880 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0040034 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Disease Transformation | Richter's syndrome | Prolymphocytic Leukemia
Item
disease transformation [i.e. richter's syndrome (lymphomas) or prolymphocytic leukemia]
boolean
C4055129 (UMLS CUI [1])
C0349631 (UMLS CUI [2])
C0023486 (UMLS CUI [3])
Study Subject Participation Status | Therapy, Investigational
Item
participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
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