ID

28072

Beskrivning

Perifosine in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00873457

Länk

https://clinicaltrials.gov/show/NCT00873457

Nyckelord

Versioner (1)
  1. 2017-12-14 2017-12-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 december 2017

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00873457

Engelsk

Eligibility Chronic Lymphocytic Leukemia NCT00873457

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
a diagnosis of cll or sll based on iwcll diagnostic criteria.
Beskrivning

Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C0855095
prior therapy for cll (no limit on number of prior regimens).
Beskrivning

Prior Therapy Quantity Chronic Lymphocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0023434
patients requiring therapy, based on at least one of the iwcll criteria.
Beskrivning

Patients Requirement Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
18 years of age or older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
performance status ecog 0, 1, or 2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
an estimated or measured creatinine clearance ≥30 ml/min at study enrollment.
Beskrivning

Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0373595
ast, alt, and total bilirubin ≤ 2.5 times the upper limit of normal, unless due to cll/sll.
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Exception Result Due to CLL/SLL

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1274040
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C1302547
female subject who is either post-menopausal or surgically sterilized or male or female subject willing to use an acceptable method of birth control for the duration of the study therapy and for 2 weeks after study therapy completion.
Beskrivning

Postmenopausal state | Female Sterilization | Contraceptive methods Willing

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0600109
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
female subject is pregnant or lactating.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient has received other investigational drugs for this disease within 14 days of enrollment.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
patient with known hiv prior to enrollment.
Beskrivning

HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Beskrivning

Disease Serious Interferes with Study Subject Participation Status | Mental disorder Serious Interferes with Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C2348568
patients with another malignancy within the last three years (from documentation of remission) other than basal or squamous cell skin cancer or cis of the cervix or early stage prostate cancer not requiring systemic treatment.
Beskrivning

Cancer Other | Remission Documented | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Prostate carcinoma Early stage | Systemic therapy Requirement Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C0687702
UMLS CUI [2,2]
C1301725
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0600139
UMLS CUI [6,3]
C2363430
UMLS CUI [7,1]
C1515119
UMLS CUI [7,2]
C1514873
UMLS CUI [7,3]
C0332197
patients who underwent allogeneic stem cell transplant and have at least 2% donor cells engrafted will be excluded.
Beskrivning

Allogeneic Stem Cell Transplantation | Engraftment Donor cells Percentage

Datatyp

boolean

Alias
UMLS CUI [1]
C2242529
UMLS CUI [2,1]
C0301944
UMLS CUI [2,2]
C2910947
UMLS CUI [2,3]
C0439165
significant cardiac or vascular events within 6 months: acute mi, unstable angina, severe peripheral vascular disease (ischemic pain at rest class 3 or worse, non-healing ulcers/wounds, congestive heart failure (nhya class ≥ 2), uncontrolled cardiac arrhythmias.
Beskrivning

Cardiac event | Vascular Diseases | Myocardial Infarction | Angina, Unstable | Peripheral Vascular Disease Severe | Ischemic pain At rest Class | Non-healing ulcer of skin | Wound, non-healed | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C0741923
UMLS CUI [2]
C0042373
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0085096
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0745417
UMLS CUI [6,2]
C0443144
UMLS CUI [6,3]
C0456387
UMLS CUI [7]
C0748826
UMLS CUI [8]
C0750433
UMLS CUI [9,1]
C0018802
UMLS CUI [9,2]
C1275491
UMLS CUI [10,1]
C0003811
UMLS CUI [10,2]
C0205318
known severe hypersensitivity to perifosine or any component of the formulation.
Beskrivning

Severe allergy Perifosine | Severe allergy Perifosine Component

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0754570
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0754570
UMLS CUI [2,3]
C1705248
life expectancy less than six months due to co-morbid illness
Beskrivning

Life Expectancy Due to Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0009488
active autoimmune hemolytic anemia or immune thrombocytopenia, requiring current steroid therapy.
Beskrivning

Autoimmune hemolytic anemia Requirement Steroid therapy | Autoimmune thrombocytopenia Requirement Steroid therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002880
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0149783
UMLS CUI [2,1]
C0242584
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0149783
de novo prolymphocytic leukemia (pll) or pll arising from cll (≥ 55% prolymphocytes).
Beskrivning

Prolymphocytic Leukemia de novo | Prolymphocytic Leukemia Due to CLL | Prolymphocytes Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023486
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C0023486
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0023434
UMLS CUI [3,1]
C0229614
UMLS CUI [3,2]
C0439165
richter's transformation
Beskrivning

Richter's syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0349631
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00873457

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma
Item
a diagnosis of cll or sll based on iwcll diagnostic criteria.
boolean
C0023434 (UMLS CUI [1])
C0855095 (UMLS CUI [2])
Prior Therapy Quantity Chronic Lymphocytic Leukemia
Item
prior therapy for cll (no limit on number of prior regimens).
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
Patients Requirement Therapeutic procedure
Item
patients requiring therapy, based on at least one of the iwcll criteria.
boolean
C0030705 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Age
Item
18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
performance status ecog 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement
Item
an estimated or measured creatinine clearance ≥30 ml/min at study enrollment.
boolean
C2711451 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Exception Result Due to CLL/SLL
Item
ast, alt, and total bilirubin ≤ 2.5 times the upper limit of normal, unless due to cll/sll.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C1274040 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C1302547 (UMLS CUI [4,4])
Postmenopausal state | Female Sterilization | Contraceptive methods Willing
Item
female subject who is either post-menopausal or surgically sterilized or male or female subject willing to use an acceptable method of birth control for the duration of the study therapy and for 2 weeks after study therapy completion.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0600109 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
female subject is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
patient has received other investigational drugs for this disease within 14 days of enrollment.
boolean
C0013230 (UMLS CUI [1])
HIV Infection
Item
patient with known hiv prior to enrollment.
boolean
C0019693 (UMLS CUI [1])
Disease Serious Interferes with Study Subject Participation Status | Mental disorder Serious Interferes with Study Subject Participation Status
Item
serious medical or psychiatric illness likely to interfere with participation in this clinical study.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Cancer Other | Remission Documented | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Prostate carcinoma Early stage | Systemic therapy Requirement Absent
Item
patients with another malignancy within the last three years (from documentation of remission) other than basal or squamous cell skin cancer or cis of the cervix or early stage prostate cancer not requiring systemic treatment.
boolean
C1707251 (UMLS CUI [1])
C0687702 (UMLS CUI [2,1])
C1301725 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0600139 (UMLS CUI [6,2])
C2363430 (UMLS CUI [6,3])
C1515119 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
Allogeneic Stem Cell Transplantation | Engraftment Donor cells Percentage
Item
patients who underwent allogeneic stem cell transplant and have at least 2% donor cells engrafted will be excluded.
boolean
C2242529 (UMLS CUI [1])
C0301944 (UMLS CUI [2,1])
C2910947 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Cardiac event | Vascular Diseases | Myocardial Infarction | Angina, Unstable | Peripheral Vascular Disease Severe | Ischemic pain At rest Class | Non-healing ulcer of skin | Wound, non-healed | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Uncontrolled
Item
significant cardiac or vascular events within 6 months: acute mi, unstable angina, severe peripheral vascular disease (ischemic pain at rest class 3 or worse, non-healing ulcers/wounds, congestive heart failure (nhya class ≥ 2), uncontrolled cardiac arrhythmias.
boolean
C0741923 (UMLS CUI [1])
C0042373 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0085096 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0745417 (UMLS CUI [6,1])
C0443144 (UMLS CUI [6,2])
C0456387 (UMLS CUI [6,3])
C0748826 (UMLS CUI [7])
C0750433 (UMLS CUI [8])
C0018802 (UMLS CUI [9,1])
C1275491 (UMLS CUI [9,2])
C0003811 (UMLS CUI [10,1])
C0205318 (UMLS CUI [10,2])
Severe allergy Perifosine | Severe allergy Perifosine Component
Item
known severe hypersensitivity to perifosine or any component of the formulation.
boolean
C2945656 (UMLS CUI [1,1])
C0754570 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0754570 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Life Expectancy Due to Comorbidity
Item
life expectancy less than six months due to co-morbid illness
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Autoimmune hemolytic anemia Requirement Steroid therapy | Autoimmune thrombocytopenia Requirement Steroid therapy
Item
active autoimmune hemolytic anemia or immune thrombocytopenia, requiring current steroid therapy.
boolean
C0002880 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0149783 (UMLS CUI [1,3])
C0242584 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0149783 (UMLS CUI [2,3])
Prolymphocytic Leukemia de novo | Prolymphocytic Leukemia Due to CLL | Prolymphocytes Percentage
Item
de novo prolymphocytic leukemia (pll) or pll arising from cll (≥ 55% prolymphocytes).
boolean
C0023486 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0023486 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0023434 (UMLS CUI [2,3])
C0229614 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Richter's syndrome
Item
richter's transformation
boolean
C0349631 (UMLS CUI [1])
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