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A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma

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: NCT00848926
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : October 26, 2011
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Tracking Information
First Submitted Date  ICMJE February 18, 2009
First Posted Date  ICMJE February 20, 2009
Results First Submitted Date  ICMJE September 15, 2011
Results First Posted Date  ICMJE October 26, 2011
Last Update Posted Date March 13, 2017
Study Start Date  ICMJE February 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2011)
Objective Response Rate by Independent Review Group [ Time Frame: up to 12 months ]
Percentage of participants 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2009)
Best clinical response [ Time Frame: Every 2 to 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
  • Complete Remission Rate by Independent Review Group [ Time Frame: up to 12 months ]
    Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
  • Duration of Objective Response by Kaplan-Meier Analysis [ Time Frame: up to approximately 4 years ]
    Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.
  • Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis [ Time Frame: up to approximately 4 years ]
    Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.
  • Progression-free Survival by Kaplan-Meier Analysis [ Time Frame: up to approximately 4 years ]
    Time from start of study treatment to disease progression per independent review group or death due to any cause.
  • Overall Survival [ Time Frame: up to approximately 6 years ]
    Time from start of study treatment to date of death due to any cause.
  • Adverse Events by Severity, Seriousness, and Relationship to Treatment [ Time Frame: up to 12 months ]
    Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). 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.
  • Hematology Laboratory Abnormalities >/= Grade 3 [ Time Frame: up to 12 months ]
    Counts of study participants with post-baseline hematology 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.
  • Chemistry Laboratory Abnormalities >/= Grade 3 [ Time Frame: up to 12 months ]
    Counts of study participants with post-baseline chemistry 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.
  • Area Under the Curve [ Time Frame: 3 weeks ]
    Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin
  • Maximum Serum Concentration [ Time Frame: 3 weeks ]
    Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
  • Time of Maximum Serum Concentration [ Time Frame: 3 weeks ]
    Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2009)
  • Duration of response, progression-free survival, overall survival [ Time Frame: Every 3 months until death or study closure ]
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month following last dose ]
  • PK profile [ Time Frame: Every 2 or 3 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: October 8, 2012)
B Symptom Resolution [ Time Frame: up to 12 months ]
Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
Official Title  ICMJE A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
Brief Summary This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Disease, Hodgkin
Intervention  ICMJE Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous infusion
Other Names:
  • SGN-35
  • ADCETRIS
Study Arms  ICMJE Experimental: Brentuximab vedotin
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: October 5, 2010)
102
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2009)
100
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date August 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-avid disease by positron emission tomography and measurable disease of at least 1.5 cm as documented by spiral computed tomography.
  • 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 brentuximab vedotin.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 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 Belgium,   Canada,   France,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00848926
Other Study ID Numbers  ICMJE SG035-0003
2008-006034-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seattle Genetics, Inc.
Study Sponsor  ICMJE Seattle Genetics, Inc.
Collaborators  ICMJE Millennium Pharmaceuticals, Inc.
Investigators  ICMJE
Study Director: Abraham Fong, MD, PhD Seattle Genetics, Inc.
PRS Account Seattle Genetics, Inc.
Verification Date June 2015

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