Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00020800
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 8, 2013
National Cancer Institute (NCI)
Information provided by:
Jonsson Comprehensive Cancer Center

Brief Summary:

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different way to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab plus fludarabine in treating patients who have Waldenstrom's macroglobulinemia.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: rituximab Drug: fludarabine phosphate Phase 2

Detailed Description:


  • Determine the objective response and time to treatment failure in patients with Waldenstrom's macroglobulinemia treated with rituximab and fludarabine.
  • Determine the toxicity of this regimen in these patients.
  • Determine if molecular remissions are achievable in patients attaining a clinical complete response when treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV over 3-6 hours once weekly on weeks 1-4, 17, 18, 30, and 31 and fludarabine IV over 10-30 minutes once daily for 5 days on weeks 5, 9, 13, 19, 23, and 27.

Patients are followed at least every 2 months for 2 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Primary Purpose: Treatment
Official Title: Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
Study Start Date : September 2001
Actual Primary Completion Date : April 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of Waldenstrom's macroglobulinemia
  • CD20 positive by bone marrow immunohistochemistry or flow cytometry
  • Presence of monoclonal paraprotein
  • IgM level at least 2 times upper limit of normal (ULN)



  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 6 months


  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 25,000/mm^3


  • Bilirubin less than 2.5 times ULN
  • SGOT less than 2.5 times ULN


  • Creatinine less than 2.5 mg/dL


  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after study
  • No serious comorbid disease
  • No uncontrolled bacterial, fungal, or viral infection
  • No other active malignancy


Biologic therapy:

  • No prior rituximab
  • No prior nucleoside analogue therapy


  • At least 30 days since prior chemotherapy

Endocrine therapy:

  • At least 30 days since prior steroid therapy
  • No concurrent corticosteroids


  • At least 30 days since prior radiotherapy


  • Not specified


  • No more than 2 prior courses of therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00020800

United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
United States, Maryland
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tuft-New England Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Ohio
Barrett Cancer Center
Cincinnati, Ohio, United States, 45267-0502
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Chedoke-McMaster Hospitals
Hamilton, Ontario, Canada, L8N 3Z5
Huddinge University Hospital
Stockholm, Sweden, SE-141 86
United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Christos E. Emmanouilides, MD Jonsson Comprehensive Cancer Center

Publications of Results: Identifier: NCT00020800     History of Changes
Other Study ID Numbers: CDR0000068714
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by Jonsson Comprehensive Cancer Center:
Waldenström macroglobulinemia

Additional relevant MeSH terms:
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Fludarabine phosphate
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Antiviral Agents
Anti-Infective Agents