ID

21386

Beschrijving

Phase II Study of Perifosine in Patients With Refractory and Relapsed Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00391560

Link

https://clinicaltrials.gov/show/NCT00391560

Trefwoorden

Versies (1)
  1. 18-04-17 18-04-17 -
Geüploaded op

18 april 2017

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia NCT00391560

Engels

Eligibility Leukemia NCT00391560

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00391560
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable remission. patients with poor-risk myelodysplasia (mds) [i.e. refractory anemia with excess blasts (raeb-1 or raeb-2) by who classification] and chronic myelomonocytic leukemia (cmml) are also candidates for this protocol. relapsed/refractory leukemias include acute non-lymphocytic leukemia (aml) by who classification, acute lymphocytic leukemia (all), chronic lymphocytic leukemia (cll), or chronic myelogenous leukemia (cml) in blast crisis. patients with agnogenic myeloid metaplasia (amm) are also eligible.
Beschrijving

Leukemia Recurrent | Leukemia refractory | Standard therapy Remission Durable | Myelodysplasia Low Risk | Refractory anaemia with excess blasts | Refractory anemia with excess blasts II | Leukemia, Myelomonocytic, Chronic | Acute Myelocytic Leukemia WHO tumor classification | Acute lymphocytic leukemia | Chronic Lymphocytic Leukemia | Blast Phase | Primary Myelofibrosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023418
UMLS CUI [1,2]
C2945760
UMLS CUI [2,1]
C0023418
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C0544452
UMLS CUI [3,3]
C0449238
UMLS CUI [4,1]
C0026985
UMLS CUI [4,2]
C3538919
UMLS CUI [5]
C0002894
UMLS CUI [6]
C1318551
UMLS CUI [7]
C0023480
UMLS CUI [8,1]
C0023467
UMLS CUI [8,2]
C1301142
UMLS CUI [9]
C0023449
UMLS CUI [10]
C0023434
UMLS CUI [11]
C0005699
UMLS CUI [12]
C0001815
ecog performance status of 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
sexually active men and women who are not surgically sterile or post menopausal must use acceptable contraceptive methods (physician will discuss acceptable methods) during the time on study and for 4 weeks following the completion of treatment. women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial.
Beschrijving

Sexually active Contraceptive methods | Female Sterilization | Postmenopausal state | Male sterilization | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Premenopausal state

Datatype

boolean

Alias
UMLS CUI [1,1]
C0241028
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0024559
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0430061
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0430057
UMLS CUI [7]
C0232969
in the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least five half-lives for noncytotoxic agents. persistent chronic toxicities from prior chemotherapy must not be greater than grade 1.
Beschrijving

Disease Rapidly progressive Absent | Cytotoxic agent | Non-Cytotoxic Agent | Chemotherapy | Toxicity chronic persistent CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1838681
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0304497
UMLS CUI [3]
C2827065
UMLS CUI [4]
C0392920
UMLS CUI [5,1]
C0600688
UMLS CUI [5,2]
C0205191
UMLS CUI [5,3]
C0205322
UMLS CUI [5,4]
C1516728
patients must have the following clinical laboratory values:
Beschrijving

Laboratory Results

Datatype

boolean

Alias
UMLS CUI [1]
C1254595
serum creatinine: <= 2.0 mg/dl
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
total bilirubin: <=1.5x the upper limit of normal unless considered due to gilbert's syndrome
Beschrijving

Serum total bilirubin measurement | Serum total bilirubin measurement Due to Gilbert Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1278039
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0017551
alanine aminotransferase (alt), or aspartate aminotransferase (ast): <= 3x the upper limit of normal unless considered due to organ leukemic involvement
Beschrijving

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement Due to Organ involvement Leukemia | Aspartate aminotransferase measurement Due to Organ involvement Leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3,1]
C0201836
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0457576
UMLS CUI [3,4]
C0023418
UMLS CUI [4,1]
C0201899
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0457576
UMLS CUI [4,4]
C0023418
must be able and willing to give written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
age equal to or greater than 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Beschrijving

Comorbidity Uncontrolled | Communicable Disease Uncontrolled | Symptomatic congestive heart failure | Cardiac Arrhythmia | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0003811
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0525058
UMLS CUI [5,3]
C0439801
UMLS CUI [6,1]
C0748872
UMLS CUI [6,2]
C0525058
UMLS CUI [6,3]
C0439801
active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure
Beschrijving

Heart Disease | Myocardial Infarction | Coronary Artery Disease Symptomatic | Cardiac Arrhythmia Uncontrolled | Congestive heart failure Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C0231220
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C0205318
patients with a history of severe hyper-reactive airway system (e.g. active asthma, copd)
Beschrijving

Hyperreactive airway disease Severe | Asthma | Chronic Obstructive Airway Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0340062
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0004096
UMLS CUI [3]
C0024117
patients receiving any other standard or investigational treatment for their hematologic malignancy
Beschrijving

Standard therapy Hematologic Neoplasm | Investigational Therapy Hematologic Neoplasm

Datatype

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0376545
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0376545
pregnant and nursing patients are excluded because the effects of perifosine on a fetus or nursing child are unknown.
Beschrijving

Pregnancy | Breast Feeding | perifosine

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0754570
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Similar models

Eligibility Leukemia NCT00391560

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00391560
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia Recurrent | Leukemia refractory | Standard therapy Remission Durable | Myelodysplasia Low Risk | Refractory anaemia with excess blasts | Refractory anemia with excess blasts II | Leukemia, Myelomonocytic, Chronic | Acute Myelocytic Leukemia WHO tumor classification | Acute lymphocytic leukemia | Chronic Lymphocytic Leukemia | Blast Phase | Primary Myelofibrosis
Item
patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable remission. patients with poor-risk myelodysplasia (mds) [i.e. refractory anemia with excess blasts (raeb-1 or raeb-2) by who classification] and chronic myelomonocytic leukemia (cmml) are also candidates for this protocol. relapsed/refractory leukemias include acute non-lymphocytic leukemia (aml) by who classification, acute lymphocytic leukemia (all), chronic lymphocytic leukemia (cll), or chronic myelogenous leukemia (cml) in blast crisis. patients with agnogenic myeloid metaplasia (amm) are also eligible.
boolean
C0023418 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0023418 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C0544452 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
C0026985 (UMLS CUI [4,1])
C3538919 (UMLS CUI [4,2])
C0002894 (UMLS CUI [5])
C1318551 (UMLS CUI [6])
C0023480 (UMLS CUI [7])
C0023467 (UMLS CUI [8,1])
C1301142 (UMLS CUI [8,2])
C0023449 (UMLS CUI [9])
C0023434 (UMLS CUI [10])
C0005699 (UMLS CUI [11])
C0001815 (UMLS CUI [12])
ECOG performance status
Item
ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Sexually active Contraceptive methods | Female Sterilization | Postmenopausal state | Male sterilization | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Premenopausal state
Item
sexually active men and women who are not surgically sterile or post menopausal must use acceptable contraceptive methods (physician will discuss acceptable methods) during the time on study and for 4 weeks following the completion of treatment. women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial.
boolean
C0241028 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0024559 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0430061 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0430057 (UMLS CUI [6,2])
C0232969 (UMLS CUI [7])
Disease Rapidly progressive Absent | Cytotoxic agent | Non-Cytotoxic Agent | Chemotherapy | Toxicity chronic persistent CTCAE Grades
Item
in the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least five half-lives for noncytotoxic agents. persistent chronic toxicities from prior chemotherapy must not be greater than grade 1.
boolean
C0012634 (UMLS CUI [1,1])
C1838681 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0304497 (UMLS CUI [2])
C2827065 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0600688 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
C0205322 (UMLS CUI [5,3])
C1516728 (UMLS CUI [5,4])
Laboratory Results
Item
patients must have the following clinical laboratory values:
boolean
C1254595 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine: <= 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Serum total bilirubin measurement Due to Gilbert Disease
Item
total bilirubin: <=1.5x the upper limit of normal unless considered due to gilbert's syndrome
boolean
C1278039 (UMLS CUI [1])
C1278039 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0017551 (UMLS CUI [2,3])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement Due to Organ involvement Leukemia | Aspartate aminotransferase measurement Due to Organ involvement Leukemia
Item
alanine aminotransferase (alt), or aspartate aminotransferase (ast): <= 3x the upper limit of normal unless considered due to organ leukemic involvement
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0457576 (UMLS CUI [3,3])
C0023418 (UMLS CUI [3,4])
C0201899 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0457576 (UMLS CUI [4,3])
C0023418 (UMLS CUI [4,4])
Informed Consent
Item
must be able and willing to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
age equal to or greater than 18 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity Uncontrolled | Communicable Disease Uncontrolled | Symptomatic congestive heart failure | Cardiac Arrhythmia | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0742758 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0525058 (UMLS CUI [5,2])
C0439801 (UMLS CUI [5,3])
C0748872 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
Heart Disease | Myocardial Infarction | Coronary Artery Disease Symptomatic | Cardiac Arrhythmia Uncontrolled | Congestive heart failure Uncontrolled
Item
active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C1956346 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0018802 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Hyperreactive airway disease Severe | Asthma | Chronic Obstructive Airway Disease
Item
patients with a history of severe hyper-reactive airway system (e.g. active asthma, copd)
boolean
C0340062 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0004096 (UMLS CUI [2])
C0024117 (UMLS CUI [3])
Standard therapy Hematologic Neoplasm | Investigational Therapy Hematologic Neoplasm
Item
patients receiving any other standard or investigational treatment for their hematologic malignancy
boolean
C2936643 (UMLS CUI [1,1])
C0376545 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C0376545 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | perifosine
Item
pregnant and nursing patients are excluded because the effects of perifosine on a fetus or nursing child are unknown.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0754570 (UMLS CUI [3])
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