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

Sponsor

Biogen (Industry)

Overall Status

Completed

CT.gov ID

NCT00048555

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

4.1

Patients Per Site

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

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 :

Nov 1, 2002

Actual Primary Completion Date :

Mar 1, 2004

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

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

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

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 [March 2010]

Secondary Outcome Measures

To evaluate PK [March 2010]
To evaluate efficacy [March 2010]
To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation [March 2010]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research site	Birmingham	Alabama	United States	35294
2	Research site	Tucson	Arizona	United States	85724
3	Research site	Los Angeles	California	United States	90095
4	Research site	Newport Beach	California	United States	92658
5	Research site	San Diego	California	United States	92121
6	Research site	Aurora	Colorado	United States	80010
7	Research site	Washington	District of Columbia	United States	20007
8	Research site	Tampa Bay	Florida	United States	33612
9	Research site	Chicago	Illinois	United States	60611
10	Research site	Maywood	Illinois	United States	60153
11	Research site	Boston	Massachusetts	United States	2115
12	Research site	Detroit,	Michigan	United States	48202
13	Research site	Rochester	Minnesota	United States	55905
14	Research site	Omaha	Nebraska	United States	68198
15	Research site	Buffalo	New York	United States	14263
16	Research site	New York	New York	United States	10021
17	Research site	Rochester	New York	United States	14642
18	Research site	Durham	North Carolina	United States	27710
19	Research site	Philadelphia	Pennsylvania	United States	1906
20	Research site	Columbia	South Carolina	United States	29210
21	Research site	Houston	Texas	United States	77030
22	Research site	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

Biogen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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. Epub 2007 Apr 29.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00048555

Other Study ID Numbers:

114-21
NCT00056043

First Posted:

Nov 5, 2002

Last Update Posted:

Sep 16, 2013

Last Verified:

Jan 1, 2011

Additional relevant MeSH terms:

Lymphoma

Lymphoma, Non-Hodgkin

Galiximab

Study Results

No Results Posted as of Sep 16, 2013