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Completed

NCT Number: NCT00004889

Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia

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.

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Key information

Conditions

Lymphoma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases Waldenstrom Macroglobulinemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cross Cancer Institute, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Biological

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.

Other names: Rituxan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Expression of CD20

    Time frame: 24 weeks

    To correlate expression and changes in expression of CD20 on waldenstrom's macroglobulinemia patient plasma cells and B-cells with clinical responses.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2002
Study completion
2005
First posted
Feb 12, 2004
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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