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Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia

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ClinicalTrials.gov Identifier: NCT00004889
Recruitment Status : Completed
First Posted : February 12, 2004
Last Update Posted : October 2, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Genentech, Inc.
Information provided by:
Jonsson Comprehensive Cancer Center

March 7, 2000
February 12, 2004
October 2, 2015
December 1999
January 2002   (Final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00004889 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
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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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma
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
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.
Intervention: Biological: rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
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July 2005
January 2002   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00004889
CDR0000067565
P30CA016042 ( U.S. NIH Grant/Contract )
UCLA-9909016
NCI-G00-1709
No
Not Provided
Not Provided
Christos Emmanouilides, MD / Principal Investigator, UCLA
Jonsson Comprehensive Cancer Center
  • National Cancer Institute (NCI)
  • Genentech, Inc.
Principal Investigator: Christos E. Emmanouilides, MD Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP