Bortezomib and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorders
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Bortezomib and Rituximab for Patients With Post Transplant Lymphoproliferative Disorders (PTLD)|
- Number of Patients with Overall (complete and partial) response rates [ Time Frame: Day 1 to 2 Years Post Treatment ] [ Designated as safety issue: No ]
- Remission duration among patients who respond to treatment [ Time Frame: Day 1 to 8 Months Post Treatment ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: Day 1 to Time of Disease Progression ] [ Designated as safety issue: No ]
- Relapse-free survival [ Time Frame: Day 1 to Time of Disease Progression ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Day 1 to Time of Death ] [ Designated as safety issue: No ]
- Safety and toxicity [ Time Frame: Day 1 through 30 days post treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Treated Patients
This group includes patients receiving Bortezomib and Rituximab for post-transplant lymphoproliferative disorders (PTLD).
375 mg/m^2 intravenously on Days 1,8, 15 and 22
Other Name: RituxanDrug: bortezomib
1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22
Other Name: Velcade
- To estimate the overall (complete and partial) response rates in patients with CD20+ post-transplant lymphoproliferative disorders treated with bortezomib and rituximab.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869323
|United States, Minnesota|
|University of Minnesota Medical Center - Fairview|
|Minneapolis, Minnesota, United States, 55455|
|United States, Missouri|
|Washington University School of Medicine - Oncology Division|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Anne H. Blaes, MD||Masonic Cancer Center, University of Minnesota|