NCT01058239

Bortezomib Plus Rituximab for EBV+ PTLD

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

* 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.

Conditions

• Post-transplant Lymphoproliferative Disease
• Solid Organ Transplant
• Stem Cell Transplant (Bone Marrow Transplant)
• Epstein Barr Virus Infections

Interventions

Type	Name	Description
DRUG	bortezomib	Given intravenously on days 1, 4, 8 and 11 of every cycle
DRUG	rituximab	given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles

Timeline

• Start date: 2011-11-01
• Primary completion: 2016-12-01
• Completion: 2017-11-01
• First posted: 2010-01-28
• Last updated: 2018-02-15
• Results posted: 2018-02-15

Locations

3 sites across 1 country: United States