ID

13546

Beschreibung

Study of the Glutaminase Inhibitor CB-839 in Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02071927

Link

https://clinicaltrials.gov/show/NCT02071927

Stichworte

Versionen (1)
  1. 15.02.16 15.02.16 -
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CC BY-NC 3.0

Hochgeladen am

15. Februar 2016

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Eligibility Acute Myeloid Leukemia (AML) NCT02071927

Englisch

Eligibility Acute Myeloid Leukemia (AML) NCT02071927

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of aml or all, relapsed or refractory after at least 1 prior treatment regimen. newly-diagnosed patients ≥ 60 years old who have refused or are considered unfit for standard chemotherapy regimens or stem cell transplantation are also eligible.
Beschreibung

diagnosis of aml or all, relapsed or refractory after at least 1 prior treatment regimen. newly-diagnosed patients ≥ 60 years old who have refused or are considered unfit for standard chemotherapy regimens or stem cell transplantation are also eligible.

Datentyp

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C0023449
patients must have no available approved therapies that confer clinical benefit
Beschreibung

no available approved therapies that confer clinical benefit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0814225
all patients must have bone marrow involvement of their tumor, with documented blast percentage of > 5%.
Beschreibung

bone marrow involvement of their tumor

Datentyp

boolean

Alias
UMLS CUI [1]
C1517677
UMLS CUI [2]
C0368761
peripheral blood blast count must be ≤ 30,000 cells/µl.
Beschreibung

peripheral blood blast count

Datentyp

boolean

Alias
UMLS CUI [1]
C0368761
eastern cooperative oncology group (ecog) performance status of 0-2
Beschreibung

ECOG

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate hepatic, renal, and cardiac function
Beschreibung

hepatic, renal and cardiac function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232164
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other current malignancy
Beschreibung

current malignancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0521116
patients with acute promyelocytic leukemia (apl)
Beschreibung

APL

Datentyp

boolean

Alias
UMLS CUI [1]
C0023487
treatment with an unapproved, investigational agent within 21 days of the first dose of study drug
Beschreibung

treatment with an unapproved, investigational agent

Datentyp

boolean

Alias
UMLS CUI [1]
C1875319
allogeneic hematopoietic stem cell transplant or donor lymphocyte infusion within 90 days prior to to the first dose of study drug
Beschreibung

stem cell transplant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1504389
UMLS CUI [1,2]
C1515895
UMLS CUI [2]
C1512034
active gvhd
Beschreibung

active gvhd

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018133
UMLS CUI [1,2]
C0205177
unable to receive medications by mouth
Beschreibung

unable to receive medications by mouth

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C0085732
major surgery within 28 days before cycle 1 day 1
Beschreibung

major surgery within 28 days before cycle 1 day 1

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
uncontrolled, active infection; patients who are known to have hiv infection/seropositivity, hepatitis a, b, or c, or cmv reactivation
Beschreibung

uncontrolled, active infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019682
UMLS CUI [3]
C0019158
UMLS CUI [4]
C0582172
significant neurotoxicity/neuropathy (grade 3 or higher) within 14 days prior to day 1
Beschreibung

neurotoxicity/neuropathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0235032
UMLS CUI [2]
C0442874
refractory nausea and vomiting or other situation that may preclude adequate absorption
Beschreibung

nausea and vomiting

Datentyp

boolean

Alias
UMLS CUI [1]
C0027497
UMLS CUI [2]
C0042963
UMLS CUI [3,1]
C0000854
UMLS CUI [3,2]
C0439801
conditions that could interfere with treatment and procedures
Beschreibung

conditions that could interfere with treatment and procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Ähnliche Modelle

Eligibility Acute Myeloid Leukemia (AML) NCT02071927

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
AML or ALL
Item
diagnosis of aml or all, relapsed or refractory after at least 1 prior treatment regimen. newly-diagnosed patients ≥ 60 years old who have refused or are considered unfit for standard chemotherapy regimens or stem cell transplantation are also eligible.
boolean
C0023467 (UMLS CUI [1])
C0023449 (UMLS CUI [2])
no available approved therapies that confer clinical benefit
Item
patients must have no available approved therapies that confer clinical benefit
boolean
C0470187 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0814225 (UMLS CUI [1,3])
bone marrow involvement of their tumor
Item
all patients must have bone marrow involvement of their tumor, with documented blast percentage of > 5%.
boolean
C1517677 (UMLS CUI [1])
C0368761 (UMLS CUI [2])
peripheral blood blast count
Item
peripheral blood blast count must be ≤ 30,000 cells/µl.
boolean
C0368761 (UMLS CUI [1])
ECOG
Item
eastern cooperative oncology group (ecog) performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
hepatic, renal and cardiac function
Item
adequate hepatic, renal, and cardiac function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232164 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
current malignancy
Item
any other current malignancy
boolean
C0006826 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
APL
Item
patients with acute promyelocytic leukemia (apl)
boolean
C0023487 (UMLS CUI [1])
treatment with an unapproved, investigational agent
Item
treatment with an unapproved, investigational agent within 21 days of the first dose of study drug
boolean
C1875319 (UMLS CUI [1])
stem cell transplant
Item
allogeneic hematopoietic stem cell transplant or donor lymphocyte infusion within 90 days prior to to the first dose of study drug
boolean
C1504389 (UMLS CUI [1,1])
C1515895 (UMLS CUI [1,2])
C1512034 (UMLS CUI [2])
active GvHD
Item
active gvhd
boolean
C0018133 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
unable to receive medications by mouth
Item
unable to receive medications by mouth
boolean
C0175795 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
major surgery
Item
major surgery within 28 days before cycle 1 day 1
boolean
C0679637 (UMLS CUI [1])
uncontrolled, active infection
Item
uncontrolled, active infection; patients who are known to have hiv infection/seropositivity, hepatitis a, b, or c, or cmv reactivation
boolean
C0009450 (UMLS CUI [1])
C0019682 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C0582172 (UMLS CUI [4])
neurotoxicity/neuropathy
Item
significant neurotoxicity/neuropathy (grade 3 or higher) within 14 days prior to day 1
boolean
C0235032 (UMLS CUI [1])
C0442874 (UMLS CUI [2])
nausea and vomiting
Item
refractory nausea and vomiting or other situation that may preclude adequate absorption
boolean
C0027497 (UMLS CUI [1])
C0042963 (UMLS CUI [2])
C0000854 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
conditions that could interfere with treatment and procedures
Item
conditions that could interfere with treatment and procedures
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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