CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 7 enrolled
Drug / intervention
bortezomib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01058239
NCT01058239Phase 2Completed

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

Massachusetts General Hospital·interventional·Posted Jan 28, 2010·Updated Feb 15, 2018

In Brief

A Phase 2 clinical trial evaluating bortezomib and rituximab for Post-transplant Lymphoproliferative Disease and 3 related conditions. Completed, enrolled 7 participants across 3 sites.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 28, 2010
Enrollment StartNov 1, 2011
Primary CompletionDec 1, 2016
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 16.4 years ago

Interventions

bortezomibdrug

Given intravenously on days 1, 4, 8 and 11 of every cycle

rituximabdrug

given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles