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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IDEC-114
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 2002
Last Updated
September 12, 2013
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00048555
Brief Title
Safety and Efficacy of IDEC-114 in Combination With Rituxan in the Treatment of Non-Hodgkin's Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IDEC-114
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
To evaluate PK
Time Frame
March 2010
Title
To evaluate efficacy
Time Frame
March 2010
Title
To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation
Time Frame
March 2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Research site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Research site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Research site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Research site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Research site
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Research site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Research site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Research site
City
Tampa Bay
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Research site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Research site
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Research site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
2115
Country
United States
Facility Name
Research site
City
Detroit,
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Research site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Research site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Research site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Research site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Research site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Research site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Research site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
1906
Country
United States
Facility Name
Research site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
Research site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17470451
Citation
Leonard JP, Friedberg JW, Younes A, Fisher D, Gordon LI, Moore J, Czuczman M, Miller T, Stiff P, Cheson BD, 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. doi: 10.1093/annonc/mdm114. Epub 2007 Apr 29.
Results Reference
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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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