ID

31765

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00963105

Stichworte

Versionen (1)
  1. 26.09.18 26.09.18 -
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See clinicaltrials.gov

Hochgeladen am

26. September 2018

DOI

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Eligibility Relapsed or Refractory Chronic Lymphocytic Leukemia NCT00963105

Englisch

Eligibility Relapsed or Refractory Chronic Lymphocytic Leukemia NCT00963105

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age | Informed Consent

Datentyp

boolean

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

Protocol Compliance

Datentyp

boolean

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

B-cell CLL

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

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
Beschreibung

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

Datentyp

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
Beschreibung

Communicable Diseases Requirement Antibiotics for systemic use

Datentyp

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
Beschreibung

Systemic therapy B-cell CLL

Datentyp

boolean

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

alemtuzumab

Datentyp

boolean

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

Prior Therapy Lenalidomide

Datentyp

boolean

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

Rash CTCAE Grades Thalidomide Induced

Datentyp

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
Beschreibung

Autologous bone marrow transplant Planned | Allogeneic bone marrow transplantation Planned

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Hyperthyroidism Uncontrolled | Hypothyroidism Uncontrolled

Datentyp

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
Beschreibung

Venous Thromboembolism

Datentyp

boolean

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

Neuropathy CTCAE Grades

Datentyp

boolean

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

Autoimmune hemolytic anemia Uncontrolled | Thrombocytopenia Uncontrolled

Datentyp

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]
Beschreibung

Disease Transformation | Richter's syndrome | Prolymphocytic Leukemia

Datentyp

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
Beschreibung

Study Subject Participation Status | Therapy, Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
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Ähnliche Modelle

Eligibility Relapsed or Refractory Chronic Lymphocytic Leukemia NCT00963105

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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