Clinical trial NCT00711828
Conditions: Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue Nodal Marginal Zone Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Splenic Marginal Zone Lymphoma Waldenstrom Macroglobulinemia
Sponsor: Mayo Clinic
Start date: 2008-08-01; Completion date: 2018-04-06
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving rituximab and cyclophosphamide together with bortezomib and dexamethasone (R-CyBor-D) works in treating patients with relapsed or refractory low-grade follicular lymphoma, Waldenstrom macroglobulinemia, or mantle cell lymphoma. 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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess tumor response to R-CyBor-D in patients with relapsed follicular (Gr 1 or 2), mantle cell, marginal zone lymphomas, small lymphocytic lymphoma (SLL)/chronic lymphocytic leukemia (CLL) and lymphoplasmacytic (Waldenstrom's macroglobulinemia) lymphoma.

SECONDARY OBJECTIVES:

I. To evaluate overall survival, progression-free survival, duration of response, and time to treatment failure of patients receiving R-CyBor-D.

II. To describe the adverse event profile (using National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] v 3.0) of R-CyBor-D.

III. To evaluate quality of life for patient reported neurotoxicity using the Gynecologic Oncology Group's Functional Assessment of Cancer Therapy (FACT/GOG) neurotoxicity questionnaire, version 4.0.

OUTLINE:

Patients receive rituximab intravenously (IV) on day 1and cyclophosphamide orally (PO), bortezomib IV, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-6 months for up to 3 years.

Arms: arm 1: Patients receive rituximab IV on day 1and cyclophosphamide PO, bortezomib IV, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Bortezomib intervention 2: Rituximab intervention 3: Cyclophosphamide intervention 4: Dexamethasone intervention 5: Questionnaire Administration intervention 6: Quality-of-Life Assessment
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given PO intervention 4: Given PO intervention 5: Complete a quality of life questionnaire (FACT/GOG neurotoxicity questionnaire, version 4.0) intervention 6: Complete a quality of life questionnaire (FACT/GOG neurotoxicity questionnaire, version 4.0)

Protocol documents: