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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00048555
First received: November 1, 2002
Last updated: September 12, 2013
Last verified: January 2011
  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 1
Phase 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 22 Study Locations
Sponsors and Collaborators
Biogen Idec
  More Information

Publications:
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: September 12, 2013
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
Antibodies, Monoclonal
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 14, 2014