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A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00947856
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : May 26, 2014
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seagen Inc.

Tracking Information
First Submitted Date  ICMJE July 24, 2009
First Posted Date  ICMJE July 28, 2009
Results First Submitted Date  ICMJE March 21, 2014
Results First Posted Date  ICMJE May 26, 2014
Last Update Posted Date February 2, 2017
Study Start Date  ICMJE July 2009
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2014)
  • Objective Response Rate by Investigator [ Time Frame: Up to approximately 38 months ]
    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 ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2009)
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month post last dose ]
  • Best clinical response [ Time Frame: Every 2 to 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2014)
  • Duration of Objective Response by Kaplan-Meier Analysis [ Time Frame: Up to 38 months ]
    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 ]
    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 ]
    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 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2009)
  • Duration of response, progression-free survival, and overall survival [ Time Frame: Every 3 months until death or study closure ]
  • Incidence of Antitherapeutic Antibodies [ Time Frame: Up to 1 month post last dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study
Official Title  ICMJE Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study
Brief Summary 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.
Detailed Description

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Disease, Hodgkin
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Non-Hodgkin
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2014)
110
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2009)
50
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00947856
Other Study ID Numbers  ICMJE SGN35-006
2010-019932-11 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seagen Inc.
Study Sponsor  ICMJE Seagen Inc.
Collaborators  ICMJE Millennium Pharmaceuticals, Inc.
Investigators  ICMJE
Study Director: Laurie Grove, PA-C Seagen Inc.
PRS Account Seagen Inc.
Verification Date December 2016

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