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

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00057343
• Other study ID #: 106-10
• Status: Terminated
• Phase: Phase 3
• First received: March 31, 2003
• Last updated: September 8, 2006
• Start date: March 2003

Study information

• Verified date: September 2006
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Zevalin (ibritumomab tiuxetan)

• Rituxan (rituximab)

Locations

Country	Name	City	State
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Aurora	Illinois
United States	Research Site	Bakersfield	California
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bismark	North Dakota
United States	Research Site	Boise	Idaho
United States	Research Site	Boston	Massachusetts
United States	Research Site	Bremerton	Washington
United States	Research Site	Bronx	New York
United States	Research Site	Buffalo	New York
United States	Research Site	Charleston	South Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Cleveland	Ohio
United States	Research Site	Coeur D'Alene	Idaho
United States	Research Site	Columbia	Missouri
United States	Research Site	Concord	California
United States	Research Site	Detroit	Michigan
United States	Research Site	Duarte	California
United States	Research Site	Evanston	Illinois
United States	Research Site	Farmington	Connecticut
United States	Research Site	Farmington	New Mexico
United States	Research Site	Flint	Michigan
United States	Research Site	Greenville	South Carolina
United States	Research Site	Harvey	Illinois
United States	Research Site	Houston	Texas
United States	Research Site	Huntsville	Alabama
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jackson	Mississippi
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kansas City	Kansas
United States	Research Site	Kansas City	Missouri
United States	Research Site	Lakeland	Florida
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Loma Linda	California
United States	Research Site	Los Angeles	California
United States	Research Site	Lubbock	Texas
United States	Research Site	Manhasset	New York
United States	Research Site	Maywood	Illinois
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Mission Viejo	California
United States	Research Site	Morgantown	West Virginia
United States	Research Site	Munster	Indiana
United States	Research Site	Nashville	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Newark	Delaware
United States	Research Site	Newport Beach	California
United States	Research Site	Orange	California
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Rochester	Minnesota
United States	Research Site	Royal Oak	Michigan
United States	Research Site	Sacramento	California
United States	Research Site	Salt Lake City	Utah
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	Scottsdale	Arizona
United States	Research Site	St. Joseph	Michigan
United States	Research Site	St. Louis	Missouri
United States	Research Site	Temple	Texas
United States	Research Site	Toledo	Ohio
United States	Research Site	Tupelo	Mississippi
United States	Research Site	Urbana	Illinois
United States	Research Site	Vallejo	California
United States	Research Site	Wausau	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival
Secondary	overall response rate
Secondary	complete response rate
Secondary	unconfirmed complete response rate
Secondary	partial response rate
Secondary	duration of response
Secondary	time to progression
Secondary	time-to-next anticancer therapy
Secondary	quality of life
Secondary	overall survival
Secondary	safety profile