|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01196208 |
|
Date of registration:
|
03/09/2010 |
|
Primary sponsor: |
|
|
Public title:
|
A Treatment-Option Study of Brentuximab Vedotin in Patients With Progression of Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
August 2010 |
|
Target sample size:
|
|
|
Recruitment status: |
Approved for marketing |
|
URL:
|
http://clinicaltrials.gov/show/NCT01196208 |
|
Study type:
|
Expanded Access |
|
Study design:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Laurie Grove, PA-C |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Seattle Genetics, Inc. |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Participated in the placebo arm of the SGN35-005 clinical study and experienced
disease progression of HL as defined by the SGN35-005 study protocol. Or in the US
only: Patients with relapsed or refractory HL or patients with relapsed or
refractory systemic ALCL who have previously failed frontline chemotherapy.
- Completed any previous treatment with radiation, chemotherapy, biologics and/or
investigational agents at least 4 weeks prior to the first dose of brentuximab
vedotin, unless underlying disease is progressing on therapy.
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 lactating
- Patients who are eligible to participate in other brentuximab vedotin clinical
studies
Age minimum:
6 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Disease, Hodgkin
|
|
Lymphoma, Large-Cell, Anaplastic
|
|
Lymphoma, Non-Hodgkin
|
|
Intervention(s)
|
|
Drug: brentuximab vedotin
|
|
Secondary ID(s)
|
|
SGN35-010
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|