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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00848926
First received: February 18, 2009
Last updated: June 30, 2014
Last verified: June 2014

February 18, 2009
June 30, 2014
February 2009
August 2010   (final data collection date for primary outcome measure)
Objective Response Rate by Independent Review Group [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
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.
Best clinical response [ Time Frame: Every 2 to 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00848926 on ClinicalTrials.gov Archive Site
  • Complete Remission Rate by Independent Review Group [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    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 23.5 months ] [ Designated as safety issue: No ]
    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 23.5 months ] [ Designated as safety issue: No ]
    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 23.5 months ] [ Designated as safety issue: No ]
    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 23.5 months ] [ Designated as safety issue: No ]
    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 ] [ 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). 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
  • Time of Maximum Serum Concentration [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
  • 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 ]
B Symptom Resolution [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
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.
Not Provided
 
A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

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.

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
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous infusion
Other Names:
  • SGN-35
  • ADCETRIS
Experimental: Brentuximab vedotin
Intervention: Drug: brentuximab vedotin
Younes A, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Ramchandren R, Bartlett NL, Cheson BD, de Vos S, Forero-Torres A, Moskowitz CH, Connors JM, Engert A, Larsen EK, Kennedy DA, Sievers EL, Chen R. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol. 2012 Jun 20;30(18):2183-9. doi: 10.1200/JCO.2011.38.0410. Epub 2012 Mar 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
102
August 2015
August 2010   (final data collection date for primary outcome measure)

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States,   France,   Belgium,   Italy
 
NCT00848926
SG035-0003, 2008-006034-10
Yes
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Study Director: Eric Sievers, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
June 2014

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