Conditions: Lymphoma Follicular Lymphoma Marginal Zone Lymphoma
Keywords: stage III grade 1 follicular lymphoma stage IV grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage IV grade 2 follicular lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 3
Healthy volunteers: no

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, such as cyclophosphamide and prednisone, 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 and by blocking blood flow to the tumor. Giving rituximab together with cyclophosphamide, bortezomib, and prednisone may kill more cancer cells.

PURPOSE: This clinical trial is studying how well giving rituximab together with cyclophosphamide, bortezomib, and prednisone works as first-line therapy in treating patients with stage III or stage IV follicular lymphoma or marginal zone lymphoma.

Detailed description:
OUTLINE:

* Induction therapy: Patients receive rituximab IV and cyclophosphamide IV over 30 minutes on day 1, bortezomib IV on days 1 and 8, and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance therapy.
* Maintenance therapy: Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Arms:
arm 1: Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):

* Rituximab

  * Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles
  * Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles
* Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles
* Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles
* Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles

Interventions: intervention 1: Rituximab intervention 2: Bortezomib intervention 3: Cyclophosphamide intervention 4: Prednisone
Intervention descriptions: intervention 1: Administered intravenously during induction and maintenance therapy per protocol. intervention 2: Administered intravenously per protocol. intervention 3: Administered intravenously per protocol. intervention 4: Administered orally (PO) per protocol.

Protocol document: