Clinical trial NCT00057343: Safety and Efficacy of Zevalin in the Treatment of Non-Hodgkin's Lymphoma
Official title: A Prospectively Randomized, Phase III, Multicenter, Controlled Trial to Evaluate the Safety and Efficacy of the Zevalin Therapeutic Regimen Plus Rituxan Compared With Rituxan Alone in Patients With Relapsed or Refractory Follicular NHL
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2003-04-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Event-free survival
Secondary outcomes:
measure: overall response rate
measure: complete response rate
measure: unconfirmed complete response rate
measure: partial response rate
measure: duration of response
measure: time to progression
measure: time-to-next anticancer therapy
measure: quality of life
measure: overall survival
measure: safety profile
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Concord
country: United States
facility: Research Site
state: California
city: Duarte
country: United States
facility: Research Site
state: California
city: Loma Linda
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Mission Viejo
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Biogen Idec Incorporated
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Barbara
country: United States
facility: Research Site
state: California
city: Vallejo
country: United States
facility: Research Site
state: California
city: Farmington
country: United States
facility: Research Site
state: Connecticut
city: Newark
country: United States
facility: Research Site
state: Delaware
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Lakeland
country: United States
facility: Research Site
state: Florida
city: Boise
country: United States
facility: Research Site
state: Idaho
city: Coeur D'Alene
country: United States
facility: Research Site
state: Idaho
city: Aurora
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Evanston
country: United States
facility: Research Site
state: Illinois
city: Harvey
country: United States
facility: Research Site
state: Illinois
city: Maywood
country: United States
facility: Research Site
state: Illinois
city: Urbana
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Munster
country: United States
facility: Research Site
state: Indiana
city: Kansas City
country: United States
facility: Research Site
state: Kansas
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Flint
country: United States
facility: Research Site
state: Michigan
city: Royal Oak
country: United States
facility: Research Site
state: Michigan
city: St. Joseph
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: Jackson
country: United States
facility: Research Site
state: Mississippi
city: Tupelo
country: United States
facility: Research Site
state: Mississippi
city: Columbia
country: United States
facility: Research Site
state: Missouri
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Farmington
country: United States
facility: Research Site
state: New Mexico
city: Bronx
country: United States
facility: Research Site
state: New York
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Manhasset
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Bismark
country: United States
facility: Research Site
state: North Dakota
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: Lubbock
country: United States
facility: Research Site
state: Texas
city: Temple
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Bremerton
country: United States
facility: Research Site
state: Washington
city: Morgantown
country: United States
facility: Research Site
state: West Virginia
city: Wausau
country: United States
facility: Research Site
state: Wisconsin
Study officials:
References: