Trial Information

A Phase II Study of Combination Rituximab-CHOP and Bortezomib (Velcade®) (R-CHOP-V) Induction Therapy Followed by Bortezomib Maintenance (VM) Therapy for Patients With Newly Diagnosed Mantle Cell Lymphoma

OBJECTIVES:

Primary

- Determine the 2-year progression-free survival rate in patients with newly diagnosed
mantle cell lymphoma treated with induction therapy comprising rituximab,
cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone, and bortezomib
followed by bortezomib maintenance (VM) therapy.

Secondary

- Determine the response rate (complete, complete unconfirmed, and partial responses) in
patients treated with this regimen.

- Determine the toxicity of VM in these patients.

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive R-CHOP-V induction therapy comprising rituximab IV
over ≤ 6 hours, cyclophosphamide IV over 15-45 minutes, doxorubicin hydrochloride IV
over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1; oral prednisone once
daily on days 1-5; and bortezomib IV over 30-90 minutes on days 1 and 4. Treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. After completion of 6 courses, patients with stable disease or
better proceed to bortezomib maintenance therapy.

- Maintenance therapy: Beginning 3 months after completion of R-CHOP-V induction therapy,
patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 3
months for up to 8 courses in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed periodically for 4 years and then
annually for 3 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.