ID

30397

Description

Study of Vorinostat (MK0683) With Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) or Mantle Cell Lymphoma (MCL) Patients (MK-0683-103); ODM derived from: https://clinicaltrials.gov/show/NCT00875056

Link

https://clinicaltrials.gov/show/NCT00875056

Keywords

Versions (1)
  1. 6/2/18 6/2/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 2, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00875056

English

Eligibility Lymphoma NCT00875056

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00875056
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is 20 to 74 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient has an histopathologically confirmed fl, or other indolent b-nhl or mcl (only relapsed / refractory fl can be included outside japan.)
Description

Lymphoma, Follicular | Indolent Non-Hodgkin Lymphoma B-cell | Mantle cell lymphoma | Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0024301
UMLS CUI [2,1]
C1334170
UMLS CUI [2,2]
C0004561
UMLS CUI [3]
C0334634
UMLS CUI [4]
C1335701
UMLS CUI [5]
C1335723
patient has at least one measurable lesion by ct scan which is defined by cheson's 1999 criteria
Description

Measurable lesion Quantity CT scan

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0040405
patient has received at least 1 but up to 4 prior chemotherapeutic regimen, the most recent therapy must have failed to induce a partial response, or there must be recurrence in case of the most recent therapy has shown complete response, or there must be relapse in case of the most recent therapy has shown partial response.
Description

Chemotherapy Regimen Quantity | Partial response failed | Recurrent disease Post Complete remission | Recurrent disease Post Partial response

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1521726
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C0277556
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0677874
UMLS CUI [4,1]
C0277556
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C1521726
patient must have adequate organ and marrow function
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient who has undergone allogenic transplant treatment or autologous stem cell transplant within 6 months
Description

Transplantation, Homologous | Transplantation of autologous hematopoietic stem cell

Data type

boolean

Alias
UMLS CUI [1]
C0040739
UMLS CUI [2]
C1831743
patient with other active malignancies or central neurological infiltration with lymphoma
Description

Cancer Other | Central Nervous System Infiltration Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C3714787
UMLS CUI [2,2]
C0332448
UMLS CUI [2,3]
C0024299
patient with severe hepatic insufficiency
Description

Hepatic Insufficiency Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C0205082
patient with history of allergic reactions attributed to any component of mk0683
Description

Allergic Reaction Vorinostat Component

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0672708
UMLS CUI [1,3]
C1705248
patient who is known to be hiv antibody-, hbv antigen- or hcv antibody-positive
Description

HIV antibody positive | Hepatitis B antigen positive | Hepatitis C antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0920548
UMLS CUI [2]
C1504344
UMLS CUI [3]
C0281863
patient who has undergone prior/concomitant treatment with mk0683 or other hdac inhibitors
Description

Vorinostat | Histone deacetylase inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C0672708
UMLS CUI [2]
C1512474
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Similar models

Eligibility Lymphoma NCT00875056

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00875056
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is 20 to 74 years old
boolean
C0001779 (UMLS CUI [1])
Lymphoma, Follicular | Indolent Non-Hodgkin Lymphoma B-cell | Mantle cell lymphoma | Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma
Item
patient has an histopathologically confirmed fl, or other indolent b-nhl or mcl (only relapsed / refractory fl can be included outside japan.)
boolean
C0024301 (UMLS CUI [1])
C1334170 (UMLS CUI [2,1])
C0004561 (UMLS CUI [2,2])
C0334634 (UMLS CUI [3])
C1335701 (UMLS CUI [4])
C1335723 (UMLS CUI [5])
Measurable lesion Quantity CT scan
Item
patient has at least one measurable lesion by ct scan which is defined by cheson's 1999 criteria
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
Chemotherapy Regimen Quantity | Partial response failed | Recurrent disease Post Complete remission | Recurrent disease Post Partial response
Item
patient has received at least 1 but up to 4 prior chemotherapeutic regimen, the most recent therapy must have failed to induce a partial response, or there must be recurrence in case of the most recent therapy has shown complete response, or there must be relapse in case of the most recent therapy has shown partial response.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1521726 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0677874 (UMLS CUI [3,3])
C0277556 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C1521726 (UMLS CUI [4,3])
Organ function | Bone Marrow function
Item
patient must have adequate organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Transplantation, Homologous | Transplantation of autologous hematopoietic stem cell
Item
patient who has undergone allogenic transplant treatment or autologous stem cell transplant within 6 months
boolean
C0040739 (UMLS CUI [1])
C1831743 (UMLS CUI [2])
Cancer Other | Central Nervous System Infiltration Lymphoma
Item
patient with other active malignancies or central neurological infiltration with lymphoma
boolean
C1707251 (UMLS CUI [1])
C3714787 (UMLS CUI [2,1])
C0332448 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
Hepatic Insufficiency Severe
Item
patient with severe hepatic insufficiency
boolean
C1306571 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Allergic Reaction Vorinostat Component
Item
patient with history of allergic reactions attributed to any component of mk0683
boolean
C1527304 (UMLS CUI [1,1])
C0672708 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
HIV antibody positive | Hepatitis B antigen positive | Hepatitis C antibody positive
Item
patient who is known to be hiv antibody-, hbv antigen- or hcv antibody-positive
boolean
C0920548 (UMLS CUI [1])
C1504344 (UMLS CUI [2])
C0281863 (UMLS CUI [3])
Vorinostat | Histone deacetylase inhibitor
Item
patient who has undergone prior/concomitant treatment with mk0683 or other hdac inhibitors
boolean
C0672708 (UMLS CUI [1])
C1512474 (UMLS CUI [2])
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