Safety and Efficacy of IDEC-114 in Combination With Rituxan in the Treatment of Non-Hodgkin's Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048555
• Other study ID #: 114-21
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 1, 2002
• Last updated: September 12, 2013
• Start date: November 2002
• Est. completion date: November 2010

Study information

• Verified date: January 2011
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine what side effects and what clinical effect, if any, the administration of this investigational product, IDEC-114 in combination with Rituxan® [Rituxan® as a single agent is approved by the United States Food and Drug Administration (FDA) to treat patients with relapsed or refractory follicular NHL], has in this patient population.

Other known NCT identifiers

• NCT00056043

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2010
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• IDEC-114
Dose Group 1 - 125 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 2 - 250 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 3 - 375 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 4 - 500 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions

Locations

Country	Name	City	State
United States	Research site	Aurora	Colorado
United States	Research site	Birmingham	Alabama
United States	Research site	Boston	Massachusetts
United States	Research site	Buffalo	New York
United States	Research site	Charlottesville	Virginia
United States	Research site	Chicago	Illinois
United States	Research site	Columbia	South Carolina
United States	Research site	Detroit,	Michigan
United States	Research site	Durham	North Carolina
United States	Research site	Houston	Texas
United States	Research site	Los Angeles	California
United States	Research site	Maywood	Illinois
United States	Research site	New York	New York
United States	Research site	Newport Beach	California
United States	Research site	Omaha	Nebraska
United States	Research site	Philadelphia	Pennsylvania
United States	Research site	Rochester	New York
United States	Research site	Rochester	Minnesota
United States	Research site	San Diego	California
United States	Research site	Tampa Bay	Florida
United States	Research site	Tucson	Arizona
United States	Research site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

References & Publications (1)

Leonard JP, Friedberg JW, Younes A, Fisher D, Gordon LI, Moore J, Czuczman M, Miller T, Stiff P, Cheson BD, Forero-Torres A, Chieffo N, McKinney B, Finucane D, Molina A. A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma. Ann Oncol. 2007 Jul;18(7):1216-23. Epub 2007 Apr 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study		March 2010	Yes
Secondary	To evaluate PK		March 2010	No
Secondary	To evaluate efficacy		March 2010	No
Secondary	To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation		March 2010	No