Clinical Trial: Bortezomib Plus Rituximab for EBV+ PTLD

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

Official Title: Bortezomib Plus Rituximab for EBV + Post Transplant Lymphoproliferative Disease (PTLD)

Brief Summary: Post transplant lymphoproliferative disease (PTLD) is a type of B-cell non-Hodgkin lymphoma that occurs in patients with weakened immune systems due to immunosuppressive medications taken after organ or stem cell transplantation. This is usually related to a virus called Epstein-Barr (EPV). Rituximab is a type of drug called an "antibody" that specifically destroys both normal and cancerous B-cells, and is commonly used for PTLD. Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) to treat multiple myeloma and a B-cell non-Hodgkin lymphoma called Mantle Cell Lymphoma, and shows significant activity in lymphoma cells caused by EBV. In this research study, we hope to learn if the addition of bortezomib to rituximab treatment can increase the rate of complete remissions and cures of PTLD after organ or stem cell transplant.

Detailed Summary:

  • Both rituximab and bortezomib will be given to participants intravenously. Each cycle of treatment will consist of 21 days. Rituximab will be given on Days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles. Bortezomib will be given on Days 1, 4, 8 and 11 of every cycle. Participants will receive a maximum of 4 cycles.
  • The following study procedures will be performed during each cycle throughout the study: Medical history review; Physical exam; Performance Status; Questionnaire; Blood draws and; PET/CT scans (After cycles 2, 4 and 6 only).
  • After Cycle 4, if the study doctor feels the participant has had a complete response to treatment, then they will continue onto the Post-Treatment Surveillance period, which will consist of regular clinic visits over two years.
  • However, if the study doctor feels the participant has had a partial response to treatment and that they may benefit from continuing, they will receive an additional two cycles of bortezomib and be given daily tablets of the antiviral drug valganciclovir to help further target EBV.

Sponsor: Massachusetts General Hospital

Current Primary Outcome: Overall Response Rate [ Time Frame: 4 months ]

Overall response rate includes both complete and partial responses assessed by PET/CT following completion of therapy


Original Primary Outcome: Determine the clinical efficacy of bortezomib plus rituximab in patients with EBV+ B-cell PTLD. [ Time Frame: 2 years ]

Current Secondary Outcome:

  • progression-free survival and overall survival [ Time Frame: 3 years ]
  • safety of bortezomib with rituximab [ Time Frame: 2 years ]
  • To evaluate effects of bortezomib/rituximab on EBV quantitative viral load [ Time Frame: 2 years ]


Original Secondary Outcome:

  • To evaluate progression-free and overall survival [ Time Frame: 3 years ]
  • To evaluate safety of bortezomib with rituximab in this patient population [ Time Frame: 2 years ]
  • To evaluate effects of bortezomib/rituximab on EBV quantitative viral load [ Time Frame: 2 years ]


Information By: Massachusetts General Hospital

Dates:
Date Received: January 26, 2010
Date Started: November 2011
Date Completion: December 2017
Last Updated: December 17, 2016
Last Verified: December 2016