Clinical trial NCT00376961
Conditions: Lymphoma
Keywords: contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma
Sponsor: SWOG Cancer Research Network
Start date: 2006-08-01; Completion date: 2017-09-01
Enrollment: 68 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Arms: arm 1: 6 21-day cycles of standard R-CHOP with 1.3 mg/m\^2 Bortezomib given on days 1 and 4 of each cycle. This is followed by 8 3-month cycles of maintenance with 1.3 mg/m\^2 Bortezomib on days 1, 4, 8 and 11 of each cycle.
Interventions: intervention 1: rituximab intervention 2: bortezomib intervention 3: cyclophosphamide intervention 4: doxorubicin hydrochloride intervention 5: prednisone intervention 6: vincristine sulfate
Intervention descriptions: intervention 1: 375 mg/m\^2 on day 1 for cycles 1-6. intervention 2: 1.3 mg/m\^2 on days 1, 4 of cycles 1-6 and on days 1, 4, 8, 11 of cycles 7-14. intervention 3: 750 mg/m\^2 on day 1 of cycles 1-6. intervention 4: 50 mg/m\^2 on day 1 of cycles 1-6. intervention 5: 100 mg on days 1-5 of cycles 1-6. intervention 6: 1.4 mg/m\^2 on day 1 of cycles 1-6.

Protocol documents: