Bortezomib Plus Rituximab for EBV+ PTLD

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Nov 30, 2011

Status verified

Jan 2018

Primary completion

Dec 31, 2016

Completion

Nov 30, 2017

Study Design

Enrollment

7 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab plus Bortezomib
  This is a single arm trial adding the new drug bortezomib to the standard drug rituximab

Primary Outcome Measure

Overall Response Rate [ Time Frame: 4 months ]

Locations (3)

Find similar trials in Boston, MA

Related Studies

• Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
  Recruiting · Arkansas Children's Hospital Research Institute · Birmingham, Alabama