Bortezomib Plus Rituximab for EBV + Post Transplant Lymphoproliferative Disease (PTLD)
- 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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
Overall response rate includes both complete and partial responses assessed by PET/CT following completion of therapy
Jeremy Abramson, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|