The purpose of this study is to provide treatment for patients who have relapsed NHL or refractory NHL, and to determine the effectiveness and safety of the Zevalin and Rituxan regimens or Rituxan therapy alone on your disease.

Condition	Treatment or Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: Zevalin (ibritumomab tiuxetan)  Drug: Rituxan (rituximab)	Phase III

Further Study Details: 

Expected Total Enrollment:  400

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Summary of major inclusion and exclusion criteria. Other Safety criteria will need to be met.

Inclusion Criteria:

• Histologically confirmed, relapsed or refractory CD20+ follicular B-cell NHL within 12 months of Study Day 1 (without clinical evidence of transformation). NHL must require treatment as determined by an increase in overall tumor size. The presence of B symptoms, and/or the presence of masses which are causing ongoing clinical symptoms.
• Bidimensionally measurable disease meeting the minimum requirement of at least 1 lesion >/= 2.0 cm in a single dimension.
• No lymphoma therapy for 3 weeks prior to Study Day 1.
• Patients must be recovered from all toxicities associated with prior surgery, radiation therapy, chemotherapy, or immunotherapy.
• Signed IRB-approved informed consent.
• Greater than 18 years of age.
• Expected survival >/= 3 months.
• WHO performance status of </= 2.
• Acceptable hematologic status, liver function, renal function, and pulmonary function.
• Female patients who are not pregnant or lactating.
• Men and women of reproductive potential who are following accepted birth control methods.

Exclusion Criteria:

• Patients with impaired bone marrow reserve, which may be indicated by prior myeloablative therapy with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue.
• Prior radioimmunotherapy, including the Zevalin regimen.
• Prior immunotherapy, including Rituxan therapy within 6 months of Study Day 1.
• Rituxan-refractory (no response to most recent Rituxan-containing regimen, or TTP was < 6 months).
• Presence of CNS lymphoma.
• Patients with chronic lymphocytic leukemia (CLL).
• Known history of HIV or AIDS.
• Serious nonmalignant disease or infection
• Major surgery, other than diagnostic surgery, within 4 weeks of Study Day 1.
• Patients who received investigational product within 4 weeks of Study Day 1 or patients who may experience long-term toxicity from a previous investigational therapy.

Alabama
      Huntsville,  Alabama,  United States
Arizona
      Scottsdale,  Arizona,  United States
Arkansas
      Little Rock,  Arkansas,  United States
California
      Biogen Idec Incorporated, San Diego,  California,  92121,  United States
      Oceanside,  California,  United States
      Newport Beach,  California,  United States
      Concord,  California,  United States
      Sacramento,  California,  United States
      San Diego,  California,  United States
      Bremerton,  California,  United States
      Bakersfield,  California,  United States
      Vallejo,  California,  United States
      Santa Barbara,  California,  United States
      Orange,  California,  United States
      Mission Viejo,  California,  United States
      Loma Linda,  California,  United States
Connecticut
      Farmington,  Connecticut,  United States
Delaware
      Newark,  Delaware,  United States
Florida
      Lakeland,  Florida,  United States
      Jacksonville,  Florida,  United States
Idaho
      Boise,  Idaho,  United States
      Coeur D Alene,  Idaho,  United States
Illinois
      Urbana,  Illinois,  United States
      Harvey,  Illinois,  United States
      Maywood,  Illinois,  United States
      Aurora,  Illinois,  United States
      Evanston,  Illinois,  United States
      Chicago,  Illinois,  United States
Indiana
      Indianapolis,  Indiana,  United States
Kansas
      Kansas City,  Kansas,  United States
Maryland
      Baltimore,  Maryland,  United States
Massachusetts
      Boston,  Massachusetts,  United States
Michigan
      Flint,  Michigan,  United States
      Detroit,  Michigan,  United States
      St. Joseph,  Michigan,  United States
      Royal Oak,  Michigan,  United States
      Grand Rapids,  Michigan,  United States
Minnesota
      Minneapolis,  Minnesota,  United States
      Rochester,  Minnesota,  United States
Mississippi
      Tupelo,  Mississippi,  United States
Missouri
      Columbia,  Missouri,  United States
      Kansas City,  Missouri,  United States
      St. Louis,  Missouri,  United States
New Mexico
      Farmington,  New Mexico,  United States
      Albuquerque,  New Mexico,  United States
New York
      Buffalo,  New York,  United States
      New York,  New York,  United States
      Bronx,  New York,  United States
      Rochester,  New York,  United States
      Manhasset,  New York,  United States
North Dakota
      Bismark,  North Dakota,  United States
Ohio
      Cleveland,  Ohio,  United States
      Toledo,  Ohio,  United States
Oregon
      Portland,  Oregon,  United States
Pennsylvania
      Pittsburgh,  Pennsylvania,  United States
      Philadelphia,  Pennsylvania,  United States
South Carolina
      Charleston,  South Carolina,  United States
      Greenville,  South Carolina,  United States
Tennessee
      Nashville,  Tennessee,  United States
Texas
      Fort Sam Houston,  Texas,  United States
      Lubbock,  Texas,  United States
      Temple,  Texas,  United States
      Houston,  Texas,  United States
Utah
      Salt Lake City,  Utah,  United States
Washington
      Bremerton,  Washington,  United States
West Virginia
      Morgantown,  West Virginia,  United States
Wisconsin
      Wausau,  Wisconsin,  United States

Study ID Numbers:  106-10
Record last reviewed:  January 2005
Last Updated:  January 7, 2005
Record first received:  March 31, 2003
ClinicalTrials.gov Identifier:  NCT00057343
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08