ID

36591

Description

Study of the Glutaminase Inhibitor CB-839 in Hematological Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT02071888

Link

https://clinicaltrials.gov/show/NCT02071888

Keywords

Versions (1)
  1. 5/24/19 5/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 24, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Hodgkin's Lymphoma (NHL) NCT02071888

English

Eligibility Non-Hodgkin's Lymphoma (NHL) NCT02071888

1 forms  
Criteria
Description

Criteria

patients must have one of the following diseases that is either relapsed or refractory to 2 or more prior treatments:
Description

Recurrent disease | Refractory Disease Prior Therapy Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C1514815
UMLS CUI [2,2]
C1514463
UMLS CUI [2,3]
C1265611
nhl: at least one measurable lesion
Description

Lymphoma, Non-Hodgkin | Measurable lesion Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0024305
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
wm: measurable igm, with a minimum level of ≥ 2x uln
Description

Waldenstrom Macroglobulinemia | Immunoglobulin M Measurable | Immunoglobulin M increased

Data type

boolean

Alias
UMLS CUI [1]
C0024419
UMLS CUI [2,1]
C0020861
UMLS CUI [2,2]
C1513040
UMLS CUI [3]
C0239990
mm: serum m-protein ≥ 0.5 g/dl and/or urine m-protein ≥ 200 mg/24 hr. in part 2, disease that is considered measurable per the imwg criteria
Description

Multiple Myeloma | Serum M Protein Measurement | M Protein In Urine Measurement

Data type

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C0229671
UMLS CUI [2,2]
C0700271
UMLS CUI [2,3]
C0242485
UMLS CUI [3,1]
C0700271
UMLS CUI [3,2]
C0042037
UMLS CUI [3,3]
C0242485
other inclusion criteria
Description

Inclusion criteria Other

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205394
eastern cooperative oncology group (ecog) performance status of 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
adequate hepatic, renal, cardiac and hematological function
Description

Liver function | Renal function | Cardiac function | Hematologic function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232164
UMLS CUI [4]
C0221130
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other current malignancy
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
treatment with an unapproved, investigational therapeutic agent, immunotherapy or biological therapy within 21 days prior to the first dose of study drug
Description

Investigational New Drugs Without Approval | Immunotherapy Without Approval | Biological treatment Without Approval

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0205540
UMLS CUI [2,1]
C0021083
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0205540
UMLS CUI [3,1]
C1531518
UMLS CUI [3,2]
C0332288
UMLS CUI [3,3]
C0205540
recent bone marrow transplant
Description

Bone Marrow Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0005961
unable to receive medications by mouth
Description

Oral medication Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
major surgery within 28 days before the first dose of study drug
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
uncontrolled, active infection; patients who are known to have hiv infection/
Description

Communicable Disease Uncontrolled | HIV Infection | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019699
seropositivity, hepatitis a, b, or c, or cmv reactivation
Description

Hepatitis A | Hepatitis B | Hepatitis C | Cytomegalovirus Infection Reactivation

Data type

boolean

Alias
UMLS CUI [1]
C0019159
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4,1]
C0010823
UMLS CUI [4,2]
C4086768
significant neurotoxicity/neuropathy (grade 3 or higher) within 14 days prior to the first dose of study drug
Description

Neurotoxicity CTCAE Grades | Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0235032
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0442874
UMLS CUI [2,2]
C1516728
refractory nausea and vomiting or other situation that may preclude adequate absorption
Description

Intractable nausea and vomiting | Condition Excludes Absorption

Data type

boolean

Alias
UMLS CUI [1]
C3697880
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0237442
other conditions that could interfere with treatment
Description

Condition Interferes with Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0087111
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Similar models

Eligibility Non-Hodgkin's Lymphoma (NHL) NCT02071888

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Recurrent disease | Refractory Disease Prior Therapy Quantity
Item
patients must have one of the following diseases that is either relapsed or refractory to 2 or more prior treatments:
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Lymphoma, Non-Hodgkin | Measurable lesion Quantity
Item
nhl: at least one measurable lesion
boolean
C0024305 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Waldenstrom Macroglobulinemia | Immunoglobulin M Measurable | Immunoglobulin M increased
Item
wm: measurable igm, with a minimum level of ≥ 2x uln
boolean
C0024419 (UMLS CUI [1])
C0020861 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
C0239990 (UMLS CUI [3])
Multiple Myeloma | Serum M Protein Measurement | M Protein In Urine Measurement
Item
mm: serum m-protein ≥ 0.5 g/dl and/or urine m-protein ≥ 200 mg/24 hr. in part 2, disease that is considered measurable per the imwg criteria
boolean
C0026764 (UMLS CUI [1])
C0229671 (UMLS CUI [2,1])
C0700271 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])
C0700271 (UMLS CUI [3,1])
C0042037 (UMLS CUI [3,2])
C0242485 (UMLS CUI [3,3])
Inclusion criteria Other
Item
other inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Liver function | Renal function | Cardiac function | Hematologic function
Item
adequate hepatic, renal, cardiac and hematological function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232164 (UMLS CUI [3])
C0221130 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Cancer Other
Item
any other current malignancy
boolean
C1707251 (UMLS CUI [1])
Investigational New Drugs Without Approval | Immunotherapy Without Approval | Biological treatment Without Approval
Item
treatment with an unapproved, investigational therapeutic agent, immunotherapy or biological therapy within 21 days prior to the first dose of study drug
boolean
C0013230 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0205540 (UMLS CUI [1,3])
C0021083 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0205540 (UMLS CUI [2,3])
C1531518 (UMLS CUI [3,1])
C0332288 (UMLS CUI [3,2])
C0205540 (UMLS CUI [3,3])
Bone Marrow Transplantation
Item
recent bone marrow transplant
boolean
C0005961 (UMLS CUI [1])
Oral medication Receive Unable
Item
unable to receive medications by mouth
boolean
C0175795 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Major surgery
Item
major surgery within 28 days before the first dose of study drug
boolean
C0679637 (UMLS CUI [1])
Communicable Disease Uncontrolled | HIV Infection | HIV Seropositivity
Item
uncontrolled, active infection; patients who are known to have hiv infection/
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0019693 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Hepatitis A | Hepatitis B | Hepatitis C | Cytomegalovirus Infection Reactivation
Item
seropositivity, hepatitis a, b, or c, or cmv reactivation
boolean
C0019159 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0010823 (UMLS CUI [4,1])
C4086768 (UMLS CUI [4,2])
Neurotoxicity CTCAE Grades | Neuropathy CTCAE Grades
Item
significant neurotoxicity/neuropathy (grade 3 or higher) within 14 days prior to the first dose of study drug
boolean
C0235032 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0442874 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Intractable nausea and vomiting | Condition Excludes Absorption
Item
refractory nausea and vomiting or other situation that may preclude adequate absorption
boolean
C3697880 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
Condition Interferes with Therapeutic procedure
Item
other conditions that could interfere with treatment
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
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