Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004889

Enrollment

Registered

2004-02-12

Start date

1999-12-31

Completion date

2005-07-31

Last updated

2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

Waldenstrom macroglobulinemia

Brief summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have Waldenstrom's macroglobulinemia.

Detailed description

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.

Interventions

BIOLOGICALrituximab

375 mg/m2 given as an intravenous (IV) infusion once weekly for four doses (days 1, 8, 15, and 22). For purposes of this study 4 weekly courses will constitute one cycle of therapy.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Response (delay in disease progression or timing of disease progression)	24 weeks	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

Secondary

Measure	Time frame	Description
Expression of CD20	24 weeks	To correlate expression and changes in expression of CD20 on waldenstrom's macroglobulinemia patient plasma cells and B-cells with clinical responses.

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026