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

July 11, 2001
January 27, 2003
January 8, 2013
September 2001
April 2003   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00020800 on Archive Site
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Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia
Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • Biological: rituximab
  • Drug: fludarabine phosphate
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Treon SP, Branagan AR, Ioakimidis L, Soumerai JD, Patterson CJ, Turnbull B, Wasi P, Emmanouilides C, Frankel SR, Lister A, Morel P, Matous J, Gregory SA, Kimby E. Long-term outcomes to fludarabine and rituximab in Waldenström macroglobulinemia. Blood. 2009 Apr 16;113(16):3673-8. doi: 10.1182/blood-2008-09-177329. Epub 2008 Nov 17.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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April 2003   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   Sweden,   United Kingdom,   United States
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Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Christos E. Emmanouilides, MD Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP