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

NCT00711828 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-04-16

Study results available
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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.

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

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)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Craig Reeder · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2013-11-30
Completion
2018-04-06

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00711828 on ClinicalTrials.gov