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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT00711828
Phase
PHASE2
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 31, 2008
Status verified
Apr 2019
Primary completion
Nov 30, 2013
Completion
Apr 6, 2018

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (R-CYBOR-D)
    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.

Primary Outcome Measure

Proportion of Responses (Complete Response or Partial Response) [ Time Frame: up to 12 cycles ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo ClinicRochesterMinnesota55905-

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