ID

20627

Description

A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies; ODM derived from: https://clinicaltrials.gov/show/NCT00621244

Link

https://clinicaltrials.gov/show/NCT00621244

Keywords

Versions (1)
  1. 3/7/17 3/7/17 -
Uploaded on

March 7, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00621244

English

Eligibility Lymphoma NCT00621244

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00621244
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients (≥18 years old) with advanced hematological malignancies who have relapsed after or are refractory to standard therapy, or for which no standard therapy exists; or, are considered inappropriate candidates for standard therapy
Description

age, advanced hematological malignancies, relapsed after or are refractory to standard therapy

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0376545
UMLS CUI [2,2]
C0679246
UMLS CUI [3]
C0277556
UMLS CUI [4]
C0205269
world health organization (who) performance status ≤ 2
Description

who performance status

Data type

boolean

Alias
UMLS CUI [1]
C1298650
patients must meet protocol-specified hematologic and non-hematologic laboratory values
Description

laboratory

Data type

boolean

Alias
UMLS CUI [1]
C0587081
patients must have adequate liver and renal function
Description

liver function, renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
Description

brain metastases, leukemic infiltration of the cerebrospinal fluid

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0162679
UMLS CUI [2,2]
C0007806
peripheral neuropathy ≥ ctcae grade 2
Description

peripheral neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0031117
unresolved diarrhea ≥ ctcae grade 2
Description

unresolved diarrhea

Data type

boolean

Alias
UMLS CUI [1]
C0267664
concurrent severe and/or uncontrolled medical conditions which may compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that may significantly alter aborption of lbh589
Description

Comorbidity; Limited (extensiveness); Protocol Compliance | Decreased cardiac function | Heart Diseases | Abnormal digestive tract function; drug absorption

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
UMLS CUI [2]
C0232166
UMLS CUI [3]
C0018799
UMLS CUI [4,1]
C0232459
UMLS CUI [4,2]
C0678745
female patients who are pregnant or breast feeding
Description

pregnancy, breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients not willing to use an effective method of birth control
Description

contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
patients taking medications specified by the protocol as prohibited for administration in combination with lbh589
Description

Pharmaceutical Preparations; Drug Interactions; LBH589

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0687133
UMLS CUI [1,3]
C1566164
patients with another primary malignancy that currently requires active intervention or is currently clinically significant
Description

Comorbidity; Malignant Neoplasms; Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0332121
other protocol-defined inclusion/exclusion criteria may apply
Description

ID.13

Data type

boolean

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Similar models

Eligibility Lymphoma NCT00621244

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00621244
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age, advanced hematological malignancies, relapsed after or are refractory to standard therapy
Item
adult patients (≥18 years old) with advanced hematological malignancies who have relapsed after or are refractory to standard therapy, or for which no standard therapy exists; or, are considered inappropriate candidates for standard therapy
boolean
C0001779 (UMLS CUI [1])
C0376545 (UMLS CUI [2,1])
C0679246 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3])
C0205269 (UMLS CUI [4])
who performance status
Item
world health organization (who) performance status ≤ 2
boolean
C1298650 (UMLS CUI [1])
laboratory
Item
patients must meet protocol-specified hematologic and non-hematologic laboratory values
boolean
C0587081 (UMLS CUI [1])
liver function, renal function
Item
patients must have adequate liver and renal function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
brain metastases, leukemic infiltration of the cerebrospinal fluid
Item
concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
boolean
C0220650 (UMLS CUI [1])
C0162679 (UMLS CUI [2,1])
C0007806 (UMLS CUI [2,2])
peripheral neuropathy
Item
peripheral neuropathy ≥ ctcae grade 2
boolean
C0031117 (UMLS CUI [1])
unresolved diarrhea
Item
unresolved diarrhea ≥ ctcae grade 2
boolean
C0267664 (UMLS CUI [1])
Comorbidity; Limited (extensiveness); Protocol Compliance | Decreased cardiac function | Heart Diseases | Abnormal digestive tract function; drug absorption
Item
concurrent severe and/or uncontrolled medical conditions which may compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that may significantly alter aborption of lbh589
boolean
C0009488 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0232166 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0232459 (UMLS CUI [4,1])
C0678745 (UMLS CUI [4,2])
pregnancy, breast feeding
Item
female patients who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
contraceptive methods
Item
patients not willing to use an effective method of birth control
boolean
C0700589 (UMLS CUI [1])
Pharmaceutical Preparations; Drug Interactions; LBH589
Item
patients taking medications specified by the protocol as prohibited for administration in combination with lbh589
boolean
C0013227 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C1566164 (UMLS CUI [1,3])
Comorbidity; Malignant Neoplasms; Treatment required for
Item
patients with another primary malignancy that currently requires active intervention or is currently clinically significant
boolean
C0009488 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
ID.13
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
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