Clinical Trial: A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Randomized, Open-Label, Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

Brief Summary: This is a Randomized, Open-Label, Phase 3 trial of brentuximab vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

Detailed Summary:
Sponsor: Millennium Pharmaceuticals, Inc.

Current Primary Outcome: Proportion of patients achieving an objective response that lasts at least 4 months [ Time Frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient) ]

To determine ORR, lasting at least 4 months, with brentuximab vedotin in patients with CD30+ MF or pcALCL compared to that achieved with therapy in the control arm


Original Primary Outcome: Proportion of patients achieving an objective response that lasts at least 4 months [ Time Frame: Change in response at the end of 21 day cycles: 3,6,9,12, and 15; at EOT; then every 12 weeks for a minimum of 24 months, and thereafter every 6 months until disease progression or study closure for up to 3 years post treatment ]

To determine ORR, lasting at least 4 months, with brentuximab vedotin in patients with CD30+ MF or pcALCL compared to that achieved with therapy in the control arm


Current Secondary Outcome:

  • Proportion of patients achieving complete response (CR) [ Time Frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient) ]
    To determine CR rate with brentuximab vedotin compared to that achieved with therapy in the control arm
  • Progression-free survival (PFS) [ Time Frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient) ]
    To determine PFS with brentuximab vedotin compared to that achieved with therapy in the control arm
  • Changes in symptom domain per Skindex-29 questionnaire [ Time Frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient) ]
    To determine burden of symptoms during treatment with brentuximab vedotin compared to that achieved with therapy in the control arm


Original Secondary Outcome:

  • Proportion of patients achieving complete response (CR) [ Time Frame: At the end of 21 day cycles: 3,6,9,12, and 15; at EOT; then every 12 weeks for a minimum of 24 months, and thereafter every 6 months until disease progression or study closure for up to 3 years post treatment ]
    To determine CR rate with brentuximab vedotin compared to that achieved with therapy in the control arm
  • Progression-free survival (PFS) [ Time Frame: At the end of 21 day cycles: 3,6,9,12, and 15; at EOT; then every 12 weeks for a minimum of 24 months, and thereafter every 6 months until disease progression or study closure for up to 3 years post treatment ]
    To determine PFS with brentuximab vedotin compared to that achieved with therapy in the control arm
  • Changes in symptom domain per Skindex-29 questionnaire [ Time Frame: Day 1 of 21 day cycles: 1,2,4,6,8,10,12,14, and 16; At EOT 30 days after the last dose, and during post treatment follow-up (for up to 3 years post treatment) ]
    To determine burden of symptoms during treatment with brentuximab vedotin compared to that achieved with therapy in the control arm


Information By: Takeda

Dates:
Date Received: March 27, 2012
Date Started: August 2012
Date Completion: July 2018
Last Updated: February 7, 2017
Last Verified: February 2017