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

Phase 2
18 Years
Open (Enrolling)
Post-transplant Lymphoproliferative Disease, Solid Organ Transplant, Stem Cell Transplant (Bone Marrow Transplant), Epstein Barr Virus Infections

Thank you

Trial Information

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.

Inclusion Criteria:

- Patients must have had a prior solid organ or allogeneic stem cell transplant.

- Patients may be newly-diagnosed or relapsed after prior therapy

- Patients must have histologically confirmed CD20+ B-cell PTLD diagnosed according to
WHO criteria. PTLD may be characterized as early lesions, PTLD/polymorphic,
PTLD/monomorphic, or PTLD/other, all of which are eligible for this trial. B-cell
PTLD must be associated with EBV as demonstrated either by detection of EBV antigens
in tumor samples, or by increased EBV quantitative viral load in serum.

- Patients must have measurable disease

- 18 years of age or older

- Estimated life expectancy of > 3 months

- ECOG Performance status of 0, 1, or 2

- Adequate organ and marrow function

- Women of childbearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation.

Exclusion Criteria:

- Patients receiving any other study agents. Patients already on prophylactic doses of
ganciclovir or valganciclovir because of a prior history of CMV infection or because
of risk factors for CMV infection are eligible for the study and may continue CMV

- Patients with known brain metastases or central nervous system (CNS) involvement of
their lymphoma.

- Patients with a history of allergic reactions attributed to compounds of similar
chemical or biologic composition to bortezomib, rituximab, ganciclovir or

- Patients with Grade 2 or greater neuropathy within 14 days before enrollment.

- Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV
heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or
electrocardiographic evidence of acute ischemia or active conduction system

- Psychiatric illness/social situations that would limit compliance with study

- Pregnant or breastfeeding women

- Individuals with a history of malignancy are ineligible except for those outlined in
the protocol

- Known HIV positive individuals

- Active HBV infection may be included only if they are on appropriate anti-hepatitis B
therapy and have an undetectable HBV viral load

- Patient has received other investigational drugs within 14 days before enrollment

- Prior bortezomib

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Description:

Overall response rate includes both complete and partial responses assessed by PET/CT following completion of therapy

Outcome Time Frame:

4 months

Safety Issue:


Principal Investigator

Jeremy Abramson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

November 2011

Completion Date:

November 2013

Related Keywords:

  • Post-transplant Lymphoproliferative Disease
  • Solid Organ Transplant
  • Stem Cell Transplant (Bone Marrow Transplant)
  • Epstein Barr Virus Infections
  • bortezomib
  • rituximab
  • PTLD
  • EBV
  • transplantation
  • Lymphoproliferative Disorders
  • Virus Diseases
  • Epstein-Barr Virus Infections



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617