A Treatment-Option Protocol to Provide Brentuximab Vedoti... | NCT01196208

Studies
A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001

NCT01196208

Sponsor

Seagen Inc.

Status

No longer available

Last Update Posted

Sep 21, 2020Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous

Interventions

brentuximab vedotin

Countries

United States
Australia
Belgium
Bulgaria
France
Germany
Hungary
Italy
Poland
Romania
Russia
Serbia
Spain
Switzerland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2010-020363-21	EudraCT Number

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

No longer available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 3, 2010

First Submission Date that Met QC Criteria

Sep 7, 2010

First Posted Date

Sep 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2020

Last Update Posted Date

Sep 21, 2020Actual

Name	Class
Millennium Pharmaceuticals, Inc.	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001

Detailed Description

The protocol was amended to reflect the change from a phase 2/3 to a study with an expanded access program (EAP) in the US that would include patients with ALCL and HL. A later amendment allowed patients with CD30-positive cutaneous T-cell lymphoma to enroll. Enrollment may continue and patients may receive brentuximab vedotin treatment on study until the drug is commercially approved and available to patients in a geographic region.

Conditions Module

Conditions

Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous

Keywords

Disease, Hodgkin
Lymphoma
Monomethylauristatin E
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Cutaneous
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Hematologic Diseases
Immunotherapy

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
brentuximab vedotin	Drug	Every 21 days by intravenous infusion (1.8 mg/kg)		SGN-35

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participated in either the SGN35-005 or C25001 clinical study and experienced progression. Patients who received brentuximab vedotin in C25001 must have had an objective response at the time of discontinuation.
Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin

Exclusion Criteria:

History of another primary malignancy that has not been in remission for at least 3 years
Known cerebral/meningeal disease
Peripheral neuropathy of grade 2 or greater
Females who are pregnant or breastfeeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Liga Ulmane, MD	PSI Company Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Cancer Center		Stanford	California	94305	United States
Dana-Farber Cancer Institute

ID	Term
D006689	Hodgkin Disease
D017728	Lymphoma, Large-Cell, Anaplastic
D008228	Lymphoma, Non-Hodgkin
D016410	Lymphoma, T-Cell, Cutaneous
D008223	Lymphoma
D006402	Hematologic Diseases

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D016399	Lymphoma, T-Cell

ID	Term
D000079963	Brentuximab Vedotin

Ancestor Terms

ID	Term
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins