Clinical Trial: Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL)

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

Official Title: A Phase I/II Clinical Trial of the Combination of Brentuximab Vedotin and Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma<

Brief Summary: This is a phase 1/2 multicenter study to assess the safety and effectiveness of brentuximab vedotin and bendamustine, when given together, in patients with Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma (ALCL) that has either returned or did not respond to initial treatment(s). Patients will be accrued at Columbia University Medical Center (CUMC) and at two subsites in Canada.

Detailed Summary: Brentuximab vedotin will be administered as an outpatient IV infusion on day 1 of each 21-day cycle. Bendamustine will be given as an outpatient infusion on days 1 and 2 of a 21-day cycle. Patients may receive prophylactic pegfilgrastim on day 3 of each cycle, or filgrastim for 5 to 10 days, per investigator's discretion. Patients can receive a maximum of 6 cycles of therapy.
Sponsor: Owen A. O'Connor

Current Primary Outcome:

  • Maximum tolerated dose (MTD) of brentuximab vedotin and bendamustine (phase 1) [ Time Frame: Up to 1.5 years ]
    The highest dose that does not cause unacceptable side effects.
  • Dose limiting toxicities (DLT) of brentuximab vedotin and bendamustine (phase 1) [ Time Frame: Up to 1.5 years ]
    A toxicity that prevents further administration of the agent at that dose level.
  • Overall Response Rate for the combination of brentuximab vedotin and bendamustine (phase 2) [ Time Frame: Up to 3 years ]
    The percentage of subjects whose cancer shrinks or disappears after study treatment - Complete Response and Partial Response.


Original Primary Outcome:

  • Phase 1: Maximum tolerated dose (MTD) of brentuximab vedotin and bendamustine [ Time Frame: Up to 1.5 years ]
  • Phase 1: Dose limiting toxicities (DLT) of brentuximab vedotin and bendamustine. [ Time Frame: Up to 1.5 years ]
  • Phase 2: Overall Response Rate (CR + PR) for the combination of brentuximab vedotin and bendamustine [ Time Frame: Up to 3 years ]


Current Secondary Outcome:

  • Duration of Response (DoR) (phase 1) [ Time Frame: Up to 3 years ]
    Time from documentation of tumor response to disease progression.
  • Progression free survival (PFS) (phase 1) [ Time Frame: Up to 3 years ]
    The length of time during and after the study treatment that a subject lives with the disease but it does not get worse.
  • Overall Survival (OS) (phase 2) [ Time Frame: Up to 3 years ]
    The length of time from either the date of diagnosis or the start of study treatment that subjects diagnosed with the disease are still alive.


Original Secondary Outcome:

  • Phase 1: Progression free survival (PFS) and duration of response (DOR) for all patients. [ Time Frame: Up to 3 years ]
  • Phase 1: Overall response rate (ORR) (complete response (CR) + partial response (PR)) for all patients [ Time Frame: up to 1.5 years ]
  • Phase 2: Safety and tolerability of the combination of brentuximab vedotin and bendamustine [ Time Frame: Up to 3 years ]
  • Phase 2: Duration of response, Progression free survival and Overall Survival (OS) for the combination of brentuximab vedotin and bendamustine [ Time Frame: Up to 3 years ]


Information By: Columbia University

Dates:
Date Received: August 2, 2012
Date Started: July 2012
Date Completion: April 2019
Last Updated: May 18, 2017
Last Verified: May 2017