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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab Galiximab

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study [ Time Frame: March 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate PK [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
To evaluate efficacy [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation [ Time Frame: March 2010 ] [ Designated as safety issue: No ]

Enrollment:	90
Study Start Date:	November 2002
Study Completion Date:	November 2010
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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

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:

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.

Responsible Party:	Study MD, Biogen Idec
ClinicalTrials.gov Identifier:	NCT00048555 History of Changes
Obsolete Identifiers:	NCT00056043
Other Study ID Numbers:	114-21
Study First Received:	November 1, 2002
Last Updated:	January 6, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 12, 2012