Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia

Phase II Study of Rituximab (Rituxan, Mabthera) in 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.

Study Overview

• Status: Completed
• Conditions: Lymphoma
• Intervention / Treatment: Biological: rituximab

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
• United States
  • California
    • Duarte, California, United States, 91010-3000
      • Cancer Center and Beckman Research Institute, City of Hope
    • Los Angeles, California, United States, 90095-1781
      • Jonsson Comprehensive Cancer Center, UCLA
  • District of Columbia
    • Washington, District of Columbia, United States, 20307-5000
      • Walter Reed Army Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rituxan; 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.	Biological: rituximab; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Christos E. Emmanouilides, MD, Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: December 1, 1999
• Primary Completion (Actual): January 1, 2002
• Study Completion (Actual): July 1, 2005

Study Registration Dates

• First Submitted: March 7, 2000
• First Submitted That Met QC Criteria: February 11, 2004
• First Posted (Estimate): February 12, 2004

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Waldenstrom macroglobulinemia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Waldenstrom Macroglobulinemia; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: CDR0000067565; UCLA-9909016; NCI-G00-1709