ID

21382

Beskrivning

A Study to Evaluate PT-523 in Patients With Refractory Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00129558

Länk

https://clinicaltrials.gov/show/NCT00129558

Nyckelord

Versioner (1)
  1. 2017-04-18 2017-04-18 -
Uppladdad den

18 april 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Leukemia NCT00129558

Engelsk

Eligibility Leukemia NCT00129558

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00129558
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsed/refractory leukemias including acute non-lymphocytic leukemia (aml), acute lymphocytic leukemia (all), chronic lymphocytic leukemia (cll), and chronic myelogenous leukemia in blastic phase (cml-bp) for which no standard therapies are anticipated to result in a durable remission; or poor-risk myelodysplasia (mds) patients to include refractory anemia with excess blasts (raeb) or excess blasts in transformation (raebt) and chronic myelomonocytic leukemia (cmml) who are either relapsed/refractory or who refuse/are not eligible for frontline therapy.
Beskrivning

Leukemia Recurrent | Leukemia refractory | Leukemia, Myelocytic, Acute | Acute lymphocytic leukemia | Chronic Lymphocytic Leukemia | Blast Phase | Standard therapy Remission Durable | Myelodysplasia Low Risk | Refractory anaemia with excess blasts | Refractory anemia with excess blasts in transformation | Leukemia, Myelomonocytic, Chronic | Patients Recurrent disease | Patients Unresponsive to Treatment | refusing treatment | Patients Ineligible Therapeutic procedure

Datatyp

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]
C0023467
UMLS CUI [4]
C0023449
UMLS CUI [5]
C0023434
UMLS CUI [6]
C0005699
UMLS CUI [7,1]
C2936643
UMLS CUI [7,2]
C0544452
UMLS CUI [7,3]
C0449238
UMLS CUI [8,1]
C0026985
UMLS CUI [8,2]
C3538919
UMLS CUI [9]
C0002894
UMLS CUI [10]
C0280028
UMLS CUI [11]
C0023480
UMLS CUI [12,1]
C0030705
UMLS CUI [12,2]
C0277556
UMLS CUI [13,1]
C0030705
UMLS CUI [13,2]
C0205269
UMLS CUI [14]
C0749657
UMLS CUI [15,1]
C0030705
UMLS CUI [15,2]
C1512714
UMLS CUI [15,3]
C0087111
only patients with refractory all or cml in lymphoid blastic phase are eligible for phase ii.
Beskrivning

Acute lymphocytic leukemia refractory | Chronic myeloid leukemia in lymphoid blast crisis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023449
UMLS CUI [1,2]
C0205269
UMLS CUI [2]
C1531551
ecog performance status 0 - 2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function and bone marrow reserve.
Beskrivning

Organ function | Mature Neutrophils Present Bone Marrow Complete

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C1708947
UMLS CUI [2,2]
C0005953
UMLS CUI [2,3]
C0205197
at least 4 weeks must have elapsed from the time of major surgery.
Beskrivning

major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
use of appropriate contraceptive method.
Beskrivning

Contraceptive methods Use of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1524063
signed patient informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known human immunodeficiency virus (hiv).
Beskrivning

HIV

Datatyp

boolean

Alias
UMLS CUI [1]
C0019682
active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.
Beskrivning

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

Datatyp

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 receiving any other standard or investigational treatment for their leukemia other than corticosteriods, hydroxyurea, and 6-mercaptopurine.
Beskrivning

Standard therapy Leukemia | Investigational Therapy Leukemia | Adrenal Cortex Hormones | hydroxyurea | mercaptopurine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0023418
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0023418
UMLS CUI [3]
C0001617
UMLS CUI [4]
C0020402
UMLS CUI [5]
C0000618
any medical condition which, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities.
Beskrivning

Medical condition High risk of Toxicity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C0600688
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Similar models

Eligibility Leukemia NCT00129558

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00129558
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia Recurrent | Leukemia refractory | Leukemia, Myelocytic, Acute | Acute lymphocytic leukemia | Chronic Lymphocytic Leukemia | Blast Phase | Standard therapy Remission Durable | Myelodysplasia Low Risk | Refractory anaemia with excess blasts | Refractory anemia with excess blasts in transformation | Leukemia, Myelomonocytic, Chronic | Patients Recurrent disease | Patients Unresponsive to Treatment | refusing treatment | Patients Ineligible Therapeutic procedure
Item
relapsed/refractory leukemias including acute non-lymphocytic leukemia (aml), acute lymphocytic leukemia (all), chronic lymphocytic leukemia (cll), and chronic myelogenous leukemia in blastic phase (cml-bp) for which no standard therapies are anticipated to result in a durable remission; or poor-risk myelodysplasia (mds) patients to include refractory anemia with excess blasts (raeb) or excess blasts in transformation (raebt) and chronic myelomonocytic leukemia (cmml) who are either relapsed/refractory or who refuse/are not eligible for frontline therapy.
boolean
C0023418 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0023418 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0023467 (UMLS CUI [3])
C0023449 (UMLS CUI [4])
C0023434 (UMLS CUI [5])
C0005699 (UMLS CUI [6])
C2936643 (UMLS CUI [7,1])
C0544452 (UMLS CUI [7,2])
C0449238 (UMLS CUI [7,3])
C0026985 (UMLS CUI [8,1])
C3538919 (UMLS CUI [8,2])
C0002894 (UMLS CUI [9])
C0280028 (UMLS CUI [10])
C0023480 (UMLS CUI [11])
C0030705 (UMLS CUI [12,1])
C0277556 (UMLS CUI [12,2])
C0030705 (UMLS CUI [13,1])
C0205269 (UMLS CUI [13,2])
C0749657 (UMLS CUI [14])
C0030705 (UMLS CUI [15,1])
C1512714 (UMLS CUI [15,2])
C0087111 (UMLS CUI [15,3])
Acute lymphocytic leukemia refractory | Chronic myeloid leukemia in lymphoid blast crisis
Item
only patients with refractory all or cml in lymphoid blastic phase are eligible for phase ii.
boolean
C0023449 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C1531551 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status 0 - 2.
boolean
C1520224 (UMLS CUI [1])
Organ function | Mature Neutrophils Present Bone Marrow Complete
Item
adequate organ function and bone marrow reserve.
boolean
C0678852 (UMLS CUI [1])
C1708947 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
major surgery
Item
at least 4 weeks must have elapsed from the time of major surgery.
boolean
C0679637 (UMLS CUI [1])
Contraceptive methods Use of
Item
use of appropriate contraceptive method.
boolean
C0700589 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Informed Consent
Item
signed patient informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HIV
Item
known human immunodeficiency virus (hiv).
boolean
C0019682 (UMLS CUI [1])
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])
Standard therapy Leukemia | Investigational Therapy Leukemia | Adrenal Cortex Hormones | hydroxyurea | mercaptopurine
Item
patients receiving any other standard or investigational treatment for their leukemia other than corticosteriods, hydroxyurea, and 6-mercaptopurine.
boolean
C2936643 (UMLS CUI [1,1])
C0023418 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C0023418 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3])
C0020402 (UMLS CUI [4])
C0000618 (UMLS CUI [5])
Medical condition High risk of Toxicity
Item
any medical condition which, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities.
boolean
C3843040 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
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