A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)

This study has been terminated.

(Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.)

Sponsor:

Information provided by:

Biogen Idec

ClinicalTrials.gov Identifier:

NCT00363636

First received: August 11, 2006

Last updated: March 17, 2011

Last verified: March 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 11, 2006
Last Updated Date	March 17, 2011
Start Date ^ICMJE	September 2006
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 24, 2008)	To assess efficacy as measured by progression free survival (PFS), and determine whether rituximab plus galiximab compared to rituximab plus placebo may extend PFS. [ Time Frame: The duration of this study is approx 4 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: August 11, 2006)	Progression-free survival
Change History	Complete list of historical versions of study NCT00363636 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 24, 2008)	Secondary efficacy measures include: event-free survival, time to progression, duration of response, complete response rate, and overall survival. [ Time Frame: The duration of this study is approx 4 years ] [ Designated as safety issue: No ] Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies. [ Time Frame: The duration of this study is approx 4 years ] [ Designated as safety issue: Yes ] Pharmacokinetics [ Time Frame: The duration of this study is approx 4 years ] [ Designated as safety issue: No ] Quality of Life using both the Functional Assessment of Cancer Therapy-Lymphoma (FACT-lym) and the EQ-5D (EuroQoL) instruments [ Time Frame: The duration of this study is approx 4 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: August 11, 2006)	Response and time-to-event variables Safety Pharmacokinetics Quality of Life
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)
Official Title ^ICMJE	A Phase III, Randomized, Double-Blind Study of Galiximab in Combination With Rituximab Compared With Rituximab in Combination With Placebo for the Treatment of Subjects With Relapsed or Refractory, Follicular Non-Hodgkin's Lymphoma
Brief Summary	This is a Phase III, multicenter, global, clinical study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with follicular NHL. The purpose of the study is to compare the clinical benefit of galiximab when given in combination with rituximab as compared with rituximab alone (given with placebo) in subjects with follicular NHL. Safety and pharmacokinetics (PK) of galiximab and rituximab will also be evaluated.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Lymphoma, Non-Hodgkin's
Intervention ^ICMJE	Drug: Galiximab in combination with rituximab Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4 Drug: Rituximab in combination with placebo Rituximab (375 mg/m2 IV) in combination with placebo, weekly x 4
Study Arm (s)	Experimental: 1 Intervention: Drug: Galiximab in combination with rituximab Active Comparator: 2 Intervention: Drug: Rituximab in combination with placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	340
Completion Date	April 2010
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Key Inclusion Criteria: Key Inclusion Criteria: Aged >= 18 years old at the time of informed consent. Histologically confirmed follicular Grade 1-3a NHL. Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment. Bidimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single dimension. Acceptable hematologic, hepatic, and renal function parameters. Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs. Key Exclusion Criteria: Follicular lymphoma Grade 3b. Rituximab refractory or refractory to anti-CD20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a TTP of less than 6 months). Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to Study Day 1 (6 weeks if nitrosourea or mitomycin C). Prior lymphoma vaccine therapy within 12 months prior to Study Day 1. Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1. Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1. Prior allogeneic transplant. Transfusion-dependent subjects. Another primary malignancy requiring active treatment (except hormonal therapy). Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor. New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00363636
Other Study ID Numbers ^ICMJE	114-NH-301
Has Data Monitoring Committee	Yes
Responsible Party	Biogen Idec MD, Biogen Idec
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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