Phase II Trial of Bortezomib and Rituximab for Patients With Post Transplant Lymphoproliferative Disorders (PTLD)
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Overall (complete and partial) response rates
Day 1 to 2 Years Post Treatment
Anne H. Blaes, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|University of Minnesota Medical Center - Fairview||Minneapolis, Minnesota 55455|
|Washington University School of Medicine - Oncology Division||St. Louis, Missouri 63110|