ID

44396

Description

A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00866047

Link

https://clinicaltrials.gov/show/NCT00866047

Keywords

Versions (2)
  1. 6/4/18 6/4/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma, Large-Cell, Anaplastic NCT00866047

English

Eligibility Lymphoma, Large-Cell, Anaplastic NCT00866047

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with relapsed or refractory systemic alcl who have previously received front line chemotherapy.
Description

Systemic Anaplastic Large Cell Lymphoma Relapsed | Systemic Anaplastic Large Cell Lymphoma refractory | Status post Chemotherapeutics regimen first line of treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1336548
UMLS CUI [1,2]
C0205336
UMLS CUI [2,1]
C1336548
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C2045825
documented anaplastic lymphoma kinase (alk) status.
Description

Anaplastic lymphoma kinase Status Documented

Data type

boolean

Alias
UMLS CUI [1,1]
C0252409
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C1301725
histologically-confirmed cd30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of cd30 expression via slides or tumor block.
Description

Disease CD30 positive | Tissue specimen Biopsy Recurrent disease | Tissue specimen Biopsy Refractory Disease | CD30 expression Slide | CD30 expression Tumor Block

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3888910
UMLS CUI [2,1]
C1292533
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C0277556
UMLS CUI [3,1]
C1292533
UMLS CUI [3,2]
C0005558
UMLS CUI [3,3]
C1514815
UMLS CUI [4,1]
C3888510
UMLS CUI [4,2]
C1705201
UMLS CUI [5,1]
C3888510
UMLS CUI [5,2]
C0027651
UMLS CUI [5,3]
C1533157
fluorodeoxyglucose-avid and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
Description

Fluorodeoxyglucose F18 Avidity PET | Measurable Disease Size PET | Fluorodeoxyglucose F18 Avidity Spiral CT | Measurable Disease Size Spiral CT

Data type

boolean

Alias
UMLS CUI [1,1]
C0046056
UMLS CUI [1,2]
C1510996
UMLS CUI [1,3]
C0032743
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0456389
UMLS CUI [2,3]
C0032743
UMLS CUI [3,1]
C0046056
UMLS CUI [3,2]
C1510996
UMLS CUI [3,3]
C0860888
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C0456389
UMLS CUI [4,3]
C0860888
received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.
Description

Autologous hematopoietic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C2193200
at us sites, patients greater than or equal to 12 years of age may be enrolled. at non-us sites, patients must be greater than or equal to 18 years of age.
Description

Age | Geographic Location

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0017446
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with brentuximab vedotin.
Description

brentuximab vedotin

Data type

boolean

Alias
UMLS CUI [1]
C2973446
previously received an allogeneic transplant.
Description

Transplantation, Homologous

Data type

boolean

Alias
UMLS CUI [1]
C0040739
patients with current diagnosis of primary cutaneous alcl (patients who have transformed to systemic alcl are eligible).
Description

Primary Cutaneous Anaplastic Large Cell Lymphoma | Patients Transformed Systemic Anaplastic Large Cell Lymphoma Eligible

Data type

boolean

Alias
UMLS CUI [1]
C1301362
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0457344
UMLS CUI [2,3]
C1336548
UMLS CUI [2,4]
C1548635
known cerebral/meningeal disease.
Description

Cerebral disorder | Meningeal disorder

Data type

boolean

Alias
UMLS CUI [1]
C0234387
UMLS CUI [2]
C0154728
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Similar models

Eligibility Lymphoma, Large-Cell, Anaplastic NCT00866047

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Systemic Anaplastic Large Cell Lymphoma Relapsed | Systemic Anaplastic Large Cell Lymphoma refractory | Status post Chemotherapeutics regimen first line of treatment
Item
patients with relapsed or refractory systemic alcl who have previously received front line chemotherapy.
boolean
C1336548 (UMLS CUI [1,1])
C0205336 (UMLS CUI [1,2])
C1336548 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C2045825 (UMLS CUI [3,2])
Anaplastic lymphoma kinase Status Documented
Item
documented anaplastic lymphoma kinase (alk) status.
boolean
C0252409 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1301725 (UMLS CUI [1,3])
Disease CD30 positive | Tissue specimen Biopsy Recurrent disease | Tissue specimen Biopsy Refractory Disease | CD30 expression Slide | CD30 expression Tumor Block
Item
histologically-confirmed cd30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of cd30 expression via slides or tumor block.
boolean
C0012634 (UMLS CUI [1,1])
C3888910 (UMLS CUI [1,2])
C1292533 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0277556 (UMLS CUI [2,3])
C1292533 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
C1514815 (UMLS CUI [3,3])
C3888510 (UMLS CUI [4,1])
C1705201 (UMLS CUI [4,2])
C3888510 (UMLS CUI [5,1])
C0027651 (UMLS CUI [5,2])
C1533157 (UMLS CUI [5,3])
Fluorodeoxyglucose F18 Avidity PET | Measurable Disease Size PET | Fluorodeoxyglucose F18 Avidity Spiral CT | Measurable Disease Size Spiral CT
Item
fluorodeoxyglucose-avid and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
boolean
C0046056 (UMLS CUI [1,1])
C1510996 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
C0046056 (UMLS CUI [3,1])
C1510996 (UMLS CUI [3,2])
C0860888 (UMLS CUI [3,3])
C1513041 (UMLS CUI [4,1])
C0456389 (UMLS CUI [4,2])
C0860888 (UMLS CUI [4,3])
Autologous hematopoietic stem cell transplant
Item
received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.
boolean
C2193200 (UMLS CUI [1])
Age | Geographic Location
Item
at us sites, patients greater than or equal to 12 years of age may be enrolled. at non-us sites, patients must be greater than or equal to 18 years of age.
boolean
C0001779 (UMLS CUI [1])
C0017446 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
brentuximab vedotin
Item
previous treatment with brentuximab vedotin.
boolean
C2973446 (UMLS CUI [1])
Transplantation, Homologous
Item
previously received an allogeneic transplant.
boolean
C0040739 (UMLS CUI [1])
Primary Cutaneous Anaplastic Large Cell Lymphoma | Patients Transformed Systemic Anaplastic Large Cell Lymphoma Eligible
Item
patients with current diagnosis of primary cutaneous alcl (patients who have transformed to systemic alcl are eligible).
boolean
C1301362 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0457344 (UMLS CUI [2,2])
C1336548 (UMLS CUI [2,3])
C1548635 (UMLS CUI [2,4])
Cerebral disorder | Meningeal disorder
Item
known cerebral/meningeal disease.
boolean
C0234387 (UMLS CUI [1])
C0154728 (UMLS CUI [2])
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