Conditions: Lymphoproliferative Disorder
Keywords: post-transplant lymphoproliferative disorder
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 3
Healthy volunteers: no

Brief summary:
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with post-transplant lymphoproliferative disorders.

Detailed description:
OBJECTIVES:

Primary

* To estimate the overall (complete and partial) response rates in patients with CD20+ post-transplant lymphoproliferative disorders treated with bortezomib and rituximab.

Secondary

* To evaluate the duration of remission, time to treatment failure, relapse-free survival, and overall survival of these patients.
* To characterize the quantitative and qualitative toxicities of this regimen.

OUTLINE:

* Induction therapy: Patients receive bortezomib intravenously (IV) and rituximab IV on days 1, 8, 15, and 22.

Patients achieving complete remission (CR) after completion of induction therapy proceed to maintenance therapy after 6 months of rest. Patients achieving partial remission (PR) or stable disease after completion of induction therapy receive additional bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/PR after completion of bortezomib therapy proceed to maintenance therapy after 3 months of rest.

* Maintenance therapy: Patients receive bortezomib IV and rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 6 months for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 2 years.

Arms:
arm 1: This group includes patients receiving Bortezomib and Rituximab for post-transplant lymphoproliferative disorders (PTLD).

Interventions: intervention 1: rituximab intervention 2: bortezomib
Intervention descriptions: intervention 1: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 intervention 2: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22

Protocol document: