Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia

Completed · Phase 2

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID

NCT00004889

Run by

Jonsson Comprehensive Cancer Center

People needed

8

Starts

1999-12-01

Expected to finish

2005-07-01

Last updated by the study team

2020-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cancer Center and Beckman Research Institute, City of Hope — Duarte, California, United States
• Jonsson Comprehensive Cancer Center, UCLA — Los Angeles, California, United States
• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Cross Cancer Institute — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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