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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00048555
Recruitment Status : Completed
First Posted : November 5, 2002
Last Update Posted : September 16, 2013
Sponsor:
Information provided by:
Biogen

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: IDEC-114 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2002
Actual Primary Completion Date : March 2004
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate PK [ Time Frame: March 2010 ]
  2. To evaluate efficacy [ Time Frame: March 2010 ]
  3. To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation [ Time Frame: March 2010 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048555


Locations
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United States, Alabama
Research site
Birmingham, Alabama, United States, 35294
United States, Arizona
Research site
Tucson, Arizona, United States, 85724
United States, California
Research site
Los Angeles, California, United States, 90095
Research site
Newport Beach, California, United States, 92658
Research site
San Diego, California, United States, 92121
United States, Colorado
Research site
Aurora, Colorado, United States, 80010
United States, District of Columbia
Research site
Washington, District of Columbia, United States, 20007
United States, Florida
Research site
Tampa Bay, Florida, United States, 33612
United States, Illinois
Research site
Chicago, Illinois, United States, 60611
Research site
Maywood, Illinois, United States, 60153
United States, Massachusetts
Research site
Boston, Massachusetts, United States, 2115
United States, Michigan
Research site
Detroit,, Michigan, United States, 48202
United States, Minnesota
Research site
Rochester, Minnesota, United States, 55905
United States, Nebraska
Research site
Omaha, Nebraska, United States, 68198
United States, New York
Research site
Buffalo, New York, United States, 14263
Research site
New York, New York, United States, 10021
Research site
Rochester, New York, United States, 14642
United States, North Carolina
Research site
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Research site
Philadelphia, Pennsylvania, United States, 1906
United States, South Carolina
Research site
Columbia, South Carolina, United States, 29210
United States, Texas
Research site
Houston, Texas, United States, 77030
United States, Virginia
Research site
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Biogen
More Information
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Publications:

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Responsible Party: Study MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00048555    
Obsolete Identifiers: NCT00056043
Other Study ID Numbers: 114-21
First Posted: November 5, 2002    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: January 2011
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Galiximab
Anti-Inflammatory Agents
Antineoplastic Agents