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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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


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
- 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Event-free survival

Authority:

United States: Food and Drug Administration

Study ID:

106-10

NCT ID:

NCT00057343

Start Date:

March 2003

Completion Date:

Related Keywords:

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

Name

Location

Research Site Alabaster, Alabama  
Research Site Mesa, Arizona  
Research Site Bentonville, Arkansas  
Research Site Anaheim, California  
Research Site Danbury, Connecticut  
Research Site Lewes, Delaware  
Research Site Boca Raton, Florida  
Research Site Boise, Idaho  
Research Site Arlington Heights, Illinois  
Research Site Bloomington, Indiana  
Research Site Hays, Kansas  
Research Site Baltimore, Maryland  
Research Site Beverly, Massachusetts  
Research Site Battle Kreek, Michigan  
Research Site Alexandria, Minnesota  
Research Site Hattiesburg, Mississippi  
Research Site Branson, Missouri  
Research Site Albuquerque, New Mexico  
Research Site Albany, New York  
Research Site Bismarck, North Dakota  
Research Site Akron, Ohio  
Research Site Bend, Oregon  
Research Site Allentown, Pennsylvania  
Research Site Charleston, South Carolina  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Ivins, Utah  
Research Site Auburn, Washington  
Research Site Clarksburg, West Virginia  
Research Site Appleton, Wisconsin  
Biogen Idec Incorporated San Diego, California  92121