NCT00711828

Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma

A Phase 2 Clinical Trial of Rituximab, Cyclophosphamide, Bortezomib (VELCADE), and Dexamethasone (R-CYBOR-D) in Relapsed Low Grade and Mantle Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Bortezomib	Given IV
BIOLOGICAL	Rituximab	Given IV
DRUG	Cyclophosphamide	Given PO
DRUG	Dexamethasone	Given PO
OTHER	Questionnaire Administration	Complete a quality of life questionnaire (FACT/GOG neurotoxicity questionnaire, version 4.0)
OTHER	Quality-of-Life Assessment	Complete a quality of life questionnaire (FACT/GOG neurotoxicity questionnaire, version 4.0)

Timeline

• Start date: 2008-08-01
• Primary completion: 2013-11-01
• Completion: 2018-04-06
• First posted: 2008-07-09
• Last updated: 2019-04-16
• Results posted: 2015-01-27

Locations

2 sites across 1 country: United States