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Bortezomib Plus Rituximab for EBV+ PTLD

NCT01058239 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2018-02-15

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Jeremy Abramson, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2016-12-31
Completion
2017-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01058239 on ClinicalTrials.gov