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

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00048555

Purpose

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.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: IDEC-114	Phase I Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab Immunoglobulins Globulin, Immune Galiximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

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

Secondary Outcome Measures:

To evaluate PK
To evaluate efficacy
To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation

Estimated Enrollment:	90
Study Start Date:	November 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048555

Show 22 Study Locations

Sponsors and Collaborators

Biogen Idec

More Information

Publications of Results:

Leonard J, Friedberg J, Younes A, Fisher D, Gordon L, Moore J, Czuczman M, Miller T, Stiff P, Cheson B, 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.

Study ID Numbers:	114-21
Study First Received:	November 1, 2002
Last Updated:	September 21, 2007
ClinicalTrials.gov Identifier:	NCT00048555
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antibodies, Monoclonal
Lymphatic Diseases
Antibodies
Immunoproliferative Disorders
Rituximab
Lymphoma, small cleaved-cell, diffuse

Lymphoma, Follicular
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Follicular lymphoma
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009