An SGN-35 Trial for Patients Who Have Previously Participated in an SGN-35 Study

This study has been completed.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00947856
First received: July 24, 2009
Last updated: May 1, 2013
Last verified: May 2013

July 24, 2009
May 1, 2013
July 2009
March 2013   (final data collection date for primary outcome measure)
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Best clinical response [ Time Frame: Every 2 to 3 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month post last dose ] [ Designated as safety issue: Yes ]
  • Best clinical response [ Time Frame: Every 2 to 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00947856 on ClinicalTrials.gov Archive Site
  • Duration of response, progression-free survival, and overall survival [ Time Frame: Every 3 months until death or study closure ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Up to 1 month post last dose ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
An SGN-35 Trial for Patients Who Have Previously Participated in an SGN-35 Study
Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study

This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with SGN-35 in patients who have previously participated in an SGN-35 study.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Disease, Hodgkin
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Non-Hodgkin
Drug: SGN-35
Every 21 days by intravenous infusion (1.2 or 1.8 mg/kg)
Other Name: brentuximab vedotin
Experimental: 1
SGN-35
Intervention: Drug: SGN-35
Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participated in a previous SGN-35 study.
  • CD30-positive hematologic malignancy.
  • At a minimum, experienced clinical benefit in the prior SGN-35 study. For retreatment, patients must have previously achieved either complete or partial remission with SGN-35 and experienced disease progression after discontinuing the prior SGN-35 study.

Exclusion Criteria:

Withdrew consent to participate in any prior SGN-35 study.

Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France
 
NCT00947856
SGN35-006
No
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Study Director: Laurie Grove, PA-C Seattle Genetics, Inc.
Seattle Genetics, Inc.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP