A Phase I/II Trial of IDEC-114 (Anti-CD80 Monoclonal Antibody) in Combination With Rituxan® for Patients With Relapsed or Refractory, Follicular Lymphoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

A Phase I/II Trial of IDEC-114 (Anti-CD80 Monoclonal Antibody) in Combination With Rituxan® for Patients With Relapsed or Refractory, Follicular Lymphoma


Inclusion Criteria:



- Signed IRB-approved informed consent

- Greater than or equal to 18 years of age

- Proof of follicular lymphoma

- Progressive disease requiring treatment after at least 1 prior standard therapy

- Acceptable hematologic status, liver function, and renal function

- Patients of reproductive potential must agree to follow accepted birth control
methods during treatment and for 3 months after completion of treatment

Exclusion Criteria:

- No response to prior Rituxan® or Rituxan®-containing regimen

- Presence of CLL or CNS lymphoma

- Known history of HIV infection or AIDS

- Prior diagnosis of aggressive NHL or mantle-cell lymphoma

- Serious nonmalignant disease

- Pregnant or currently breast feeding

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study

Outcome Time Frame:

March 2010

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

114-21

NCT ID:

NCT00048555

Start Date:

November 2002

Completion Date:

November 2010

Related Keywords:

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

Name

Location
Research Site Alabaster, Alabama  
Research Site Mesa, Arizona  
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Washington, District of Columbia  
Research Site Boca Raton, Florida  
Research Site Arlington Heights, Illinois  
Research Site Beverly, Massachusetts  
Research Site Battle Kreek, Michigan  
Research Site Alexandria, Minnesota  
Research Site Grand Island, Nebraska  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Allentown, Pennsylvania  
Research Site Charleston, South Carolina  
Research Site Abilene, Texas  
Research Site Abington, Virginia