Safety and Efficacy of Zevalin in the Treatment of Non-Hodgkin's Lymphoma

Stopped early · Phase 3

Conditions studied: Non-Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID: NCT00057343
Run by: Biogen
People needed: 400
Starts: 2003-03-01
Last updated by the study team: 2006-09-12

Who can join

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

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Research Site — Scottsdale, Arizona, United States
Research Site — Little Rock, Arkansas, United States
Research Site — Bakersfield, California, United States
Research Site — Concord, California, United States
Research Site — Duarte, California, United States
Research Site — Loma Linda, California, United States
Research Site — Los Angeles, California, United States
Research Site — Mission Viejo, California, United States
Research Site — Newport Beach, California, United States
Research Site — Orange, California, United States
Research Site — Sacramento, California, United States
Biogen Idec Incorporated — San Diego, California, United States
Research Site — San Diego, California, United States
Research Site — Santa Barbara, California, United States
Research Site — Vallejo, California, United States
Research Site — Farmington, Connecticut, United States
Research Site — Newark, Delaware, United States
Research Site — Jacksonville, Florida, United States
Research Site — Lakeland, Florida, United States
Research Site — Boise, Idaho, United States
Research Site — Coeur d'Alene, Idaho, United States
Research Site — Aurora, Illinois, United States
Research Site — Chicago, Illinois, United States
Research Site — Evanston, Illinois, United States
Research Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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