NCT00869323

Bortezomib and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorders

Phase II Trial of Bortezomib and Rituximab for Patients With Post Transplant Lymphoproliferative Disorders (PTLD)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoproliferative Disorder

Interventions

Type	Name	Description
BIOLOGICAL	rituximab	375 mg/m\^2 intravenously on Days 1,8, 15 and 22
DRUG	bortezomib	1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22

Timeline

• Start date: 2009-03-01
• Primary completion: 2013-03-01
• Completion: 2016-12-01
• First posted: 2009-03-26
• Last updated: 2017-12-05
• Results posted: 2017-04-05

Locations

2 sites across 1 country: United States