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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01196208




Registration number
NCT01196208
Ethics application status
Date submitted
3/09/2010
Date registered
8/09/2010
Date last updated
21/09/2020

Titles & IDs
Public title
A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001
Scientific title
An Open-label, Treatment-option Protocol of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma, or CD30-positive Cutaneous T-cell Lymphoma
Secondary ID [1] 0 0
2010-020363-21
Secondary ID [2] 0 0
SGN35-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disease, Hodgkin 0 0
Lymphoma, Large-Cell, Anaplastic 0 0
Lymphoma, Non-Hodgkin 0 0
Lymphoma, T-Cell, Cutaneous 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - brentuximab vedotin

Treatment: Drugs: brentuximab vedotin
Every 21 days by intravenous infusion (1.8 mg/kg)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
6 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
No longer available
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Sofia
Country [6] 0 0
France
State/province [6] 0 0
Cedex 10
Country [7] 0 0
France
State/province [7] 0 0
Lyon
Country [8] 0 0
France
State/province [8] 0 0
Rouen
Country [9] 0 0
Germany
State/province [9] 0 0
Minden
Country [10] 0 0
Hungary
State/province [10] 0 0
Budapest
Country [11] 0 0
Hungary
State/province [11] 0 0
Debrecen
Country [12] 0 0
Hungary
State/province [12] 0 0
Szeged
Country [13] 0 0
Italy
State/province [13] 0 0
Bologna
Country [14] 0 0
Italy
State/province [14] 0 0
Genoa
Country [15] 0 0
Poland
State/province [15] 0 0
Lodz
Country [16] 0 0
Poland
State/province [16] 0 0
Warsaw
Country [17] 0 0
Romania
State/province [17] 0 0
Judetul Mures
Country [18] 0 0
Romania
State/province [18] 0 0
Bucharest
Country [19] 0 0
Russian Federation
State/province [19] 0 0
Moscow
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Novosibirsk
Country [21] 0 0
Russian Federation
State/province [21] 0 0
St. Petersburg
Country [22] 0 0
Serbia
State/province [22] 0 0
Belgrade
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid
Country [24] 0 0
Switzerland
State/province [24] 0 0
Zurich
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Birmingham
Country [26] 0 0
United Kingdom
State/province [26] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Seattle Genetics, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Millennium Pharmaceuticals, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT01196208
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Liga Ulmane, MD
Address 0 0
PSI Company Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01196208