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Phase II Study of Rituximab (Rituxan, Mabthera) in Waldenstrom's Macroglobulinemia

Phase 2
18 Years
Not Enrolling

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Trial Information

Phase II Study of Rituximab (Rituxan, Mabthera) in Waldenstrom's Macroglobulinemia

OBJECTIVES: I. Determine the objective response, time to treatment failure, and toxicity in
patients with Waldenstrom's macroglobulinemia treated with rituximab. II. Correlate
expression and changes in expression of CD20 on patient plasma cells and B-cells with
clinical responses.

OUTLINE: This is a multicenter study. Patients receive rituximab IV weekly for 4 weeks.
Treatment may be repeated 2 months later in patients with stable disease, partial response,
or complete response. Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 12-25 patients will be accrued for this study.

Inclusion Criteria:

- Waldenstrom's Macroglobulinemia requiring therapy who have received no more than 2
prior courses of therapy; previously untreated patients with slowly progressive WM if
the patient can reasonably be expected to not require chemotherapy or steroid therapy
for 90 days

- CD20 positive tumor cells

- Presence of monoclonal paraprotein

- Minimum IgM level > 2 times the upper limit of normal

- Adequate organ function: ANC>1000/uL; PLT > 25000/uL; serum creatinine < 2.5; serum
total bilirubin and SGOT < 2.5 times the upper limit of normal

- 18 years and older

- Life expectancy of 6 months or greater

- ECOG performance status of 0-2

- Men and women of reproductive potential must agree to use an acceptable method of
birth control during treatment and for 6 months after completion of treatment

Exclusion Criteria:

- Chemotherapy, steroid therapy, or radiation therapy within 30 days of study entry

- Patients who are pregnant

- Serious co-morbid disease

- Uncontrolled bacterial, fungal, or viral infection

- Active second malignancy

- Individuals who cannot provide informed written consent

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response (delay in disease progression or timing of disease progression)

Outcome Description:

Define objective response (delay in disease progression or timing of disease progression), time to treatment failure, and toxicity for single agent Rituxan therapy in Waldenstrom's macroglobulinemia patients

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Christos E. Emmanouilides, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 1999

Completion Date:

July 2005

Related Keywords:

  • Lymphoma
  • Waldenstrom macroglobulinemia
  • Lymphoma
  • Waldenstrom Macroglobulinemia



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Cancer Center and Beckman Research Institute, City of Hope Duarte, California  91010-3000
Brigham and Women's Hospital Boston, Massachusetts  02115