S0601 Rituximab, Combination Chemotherapy, and Bortezomib Followed by Bortezomib Alone in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer 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. Drugs used in chemotherapy work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the
      enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and
      bortezomib may kill more cancer cells. Giving bortezomib as maintenance therapy may keep the
      cancer from progressing.

      PURPOSE: This phase II trial is studying how well giving rituximab together with combination
      chemotherapy and bortezomib followed by bortezomib alone works in treating patients with
      newly diagnosed mantle cell lymphoma.
    

Detailed description: 
      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.
    

Intervention name(s): rituximab; bortezomib; cyclophosphamide; doxorubicin hydrochloride; prednisone; vincristine sulfate
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 375 mg/m^2 on day 1 for cycles 1-6.; 1.3 mg/m^2 on days 1, 4 of cycles 1-6 and on days 1, 4, 8, 11 of cycles 7-14.; 750 mg/m^2 on day 1 of cycles 1-6.; 50 mg/m^2 on day 1 of cycles 1-6.; 100 mg on days 1-5 of cycles 1-6.; 1.4 mg/m^2 on day 1 of cycles 1-6.
Other intervention name(s): Rituxan; Velcade
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contiguous stage II mantle cell lymphoma; noncontiguous stage II mantle cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma