Clinical Trial: A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)

Brief Summary: This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.

Detailed Summary:
Sponsor: Seattle Genetics, Inc.

Current Primary Outcome: 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: Best clinical response [ Time Frame: Every 2 to 3 months ]

Current Secondary Outcome:

  • 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 3 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 3 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 3 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 7 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:

  • 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 ]


Information By: Seattle Genetics, Inc.

Dates:
Date Received: March 19, 2009
Date Started: March 2009
Date Completion:
Last Updated: February 2, 2017
Last Verified: December 2016