A Pivotal Open-Label Trial of SGN-35 for Hodgkin Lymphoma - Tabular View

Tracking Information

First Received Date ^ICMJE

February 18, 2009

Last Updated Date

September 24, 2009

Start Date ^ICMJE

February 2009

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Best clinical response [ Time Frame: Every 2 to 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00848926 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of response, progression-free survival, overall survival [ Time Frame: Every 3 months until death or study closure ] [ Designated as safety issue: No ]
Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
PK profile [ Time Frame: Every 2 or 3 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Pivotal Open-Label Trial of SGN-35 for Hodgkin Lymphoma

Official Title ^ICMJE

A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin's Lymphoma (HL)

Brief Summary

This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of SGN-35 as a single agent in patients with relapsed or refractory Hodgkin lymphoma.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Disease, Hodgkin

Intervention ^ICMJE

Drug: SGN-35

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

100

Completion Date

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant.
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.
Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm as documented by spiral CT.
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.

Exclusion Criteria:

Previous treatment with SGN-35.
Previously received an allogeneic transplant.
Congestive heart failure, Class III or IV, by the New York Heart Association criteria.
History of another primary malignancy that has not been in remission for at least 3 years.
Known cerebral/meningeal disease.

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Canada, France, Italy

Administrative Information

NCT ID ^ICMJE

NCT00848926

Responsible Party

Eric Sievers, MD, Seattle Genetics

Study ID Numbers ^ICMJE

SG035-0003

Study Sponsor ^ICMJE

Seattle Genetics, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Eric Sievers, MD

Seattle Genetics, Inc.

Information Provided By

Seattle Genetics, Inc.

Verification Date

September 2009

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