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Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004889
First Posted: February 12, 2004
Last Update Posted: October 2, 2015
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.
Collaborators:
National Cancer Institute (NCI)
Genentech, Inc.
Information provided by:
Jonsson Comprehensive Cancer Center
  Purpose

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.


Condition Intervention Phase
Lymphoma Biological: rituximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Rituximab (Rituxan, Mabthera) in Waldenstrom's Macroglobulinemia

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 8
Study Start Date: December 1999
Study Completion Date: July 2005
Primary Completion Date: January 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Rituxan

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004889


Locations
United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Genentech, Inc.
Investigators
Principal Investigator: Christos E. Emmanouilides, MD Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Christos Emmanouilides, MD / Principal Investigator, UCLA
ClinicalTrials.gov Identifier: NCT00004889     History of Changes
Other Study ID Numbers: CDR0000067565
P30CA016042 ( U.S. NIH Grant/Contract )
UCLA-9909016
NCI-G00-1709
First Submitted: March 7, 2000
First Posted: February 12, 2004
Last Update Posted: October 2, 2015
Last Verified: July 2012

Keywords provided by Jonsson Comprehensive Cancer Center:
Waldenstrom macroglobulinemia

Additional relevant MeSH terms:
Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents