A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin 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 30, 2014
Last verified: May 2014

July 24, 2009
May 30, 2014
July 2009
March 2013   (final data collection date for primary outcome measure)
  • Objective Response Rate by Investigator [ Time Frame: Up to approximately 38 months ] [ Designated as safety issue: No ]
    Percentage of participants in the retreatment arm who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
  • Adverse Events by Severity, Seriousness, and Relationship to Treatment [ Time Frame: up to 39 months ] [ Designated as safety issue: Yes ]
    Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on SGN35-006). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
  • Laboratory Abnormalities >/= Grade 3 [ Time Frame: Up to 39 months ] [ Designated as safety issue: Yes ]
    Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.
  • 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 Objective Response by Kaplan-Meier Analysis [ Time Frame: Up to 38 months ] [ Designated as safety issue: No ]
    Duration of objective response (CR + PR) on retreatment, defined as time of initial response until disease progression or death
  • Progression-free Survival by Kaplan-Meier Analysis [ Time Frame: Up to approximately 29 months ] [ Designated as safety issue: No ]
    Progression-free survival, defined as time from start of study treatment in the retreatment arm to disease progression per investigator or death due to any cause
  • Overall Survival [ Time Frame: Up to approximately 41 months ] [ Designated as safety issue: No ]
    Overall survival for both extension and retreatment arms, defined as time from start of study treatment to date of death due to any cause
  • Incidence of Antitherapeutic Antibodies [ Time Frame: Up to 39 months ] [ Designated as safety issue: Yes ]
    Counts of participants with anti-brentuximab vedotin antibodies at any time during extension treatment on Study SGN35-006 or number of retreatment experiences with anti-brentuximab vedotin antibodies at any time during retreatment
  • 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 ]
Not Provided
Not Provided
 
A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin 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 brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study.

This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (SGN-35) treatment in patients who previously participated in a brentuximab vedotin study, including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008 (NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if eligible. The study consisted of 2 arms, as follows:

  • Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a complete remission (CR) or partial remission (PR) with previous brentuximab vedotin treatment on a clinical study and subsequently experienced disease progression or relapse. The purpose of this arm was to assess safety and efficacy of retreatment with brentuximab vedotin.
  • Extension treatment arm: Patients with either CD30-positive hematologic or nonhematologic malignancies who completed treatment in a prior brentuximab vedotin study without unacceptable toxicity and experienced clinical benefit as assessed by the investigator. The purpose of this arm was to enable patients who participated in certain prior brentuximab vedotin trials to receive extension treatment and to assess patient safety and survival in the extension treatment setting.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Disease, Hodgkin
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Non-Hodgkin
Drug: brentuximab vedotin
Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure
Other Name: Adcetris
  • Experimental: BV Retreatment
    Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
    Intervention: Drug: brentuximab vedotin
  • Experimental: BV Extension
    Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
    Intervention: Drug: brentuximab vedotin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Withdrew consent to participate in any prior brentuximab vedotin study.

Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France
 
NCT00947856
SGN35-006, 2010-019932-11
No
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Study Director: Laurie Grove, PA-C Seattle Genetics, Inc.
Seattle Genetics, Inc.
May 2014

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