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

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ClinicalTrials.gov Identifier: NCT00048555
Recruitment Status : Completed
First Posted : November 5, 2002
Last Update Posted : September 16, 2013
Information provided by:

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 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
Primary Completion Date : March 2004
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

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

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

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Sponsors and Collaborators

Responsible Party: Study MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00048555     History of Changes
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:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents