Retreatment Study of Galiximab + Rituximab 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:

NCT00384150

First received: October 4, 2006

Last updated: January 6, 2011

Last verified: January 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 4, 2006
Last Updated Date	January 6, 2011
Start Date ^ICMJE	November 2007
Estimated Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 20, 2007)	Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies [ Time Frame: Study period is approx. 2 years ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: October 4, 2006)	Safety
Change History	Complete list of historical versions of study NCT00384150 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 24, 2008)	Pharmacokinetics [ Time Frame: Study period is approx. 2 years ] [ Designated as safety issue: No ] To further characterize the efficacy profile of galiximab in combination with rituximab [ Time Frame: Study period is approx. 2 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: October 4, 2006)	Pharmacokinetics Efficacy
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL)
Official Title ^ICMJE	A Phase III, Open-Label, Multicenter, Single-Arm, Retreatment Study of Galiximab in Combination With Rituximab for Subjects With Relapsed, Follicular Non-Hodgkin's Lymphoma Who Previously Responded on Study 114-NH-301
Brief Summary	This is a Phase III, multicenter, global, open-label, single-arm, retreatment study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with relapsed or refractory, follicular NHL who demonstrated a response on Study 114-NH-301 with a time-to-progression >=6 months.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Non-Hodgkin Lymphoma
Intervention ^ICMJE	Drug: galiximab in combination with rituximab galiximab (500 mg/m2 IV) in combination with rituximab (375 mg/m2 IV)once weekly for 4 weeks.
Study Arm (s)	Not Provided
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	16
Estimated Completion Date	March 2010
Estimated Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Key Inclusion Criteria: Demonstrated a response (CR, CRu, or PR) on Study 114-NH-301 (Galiximab in combination with Rituximab compared with Rituximab in combination with Placebo) and then relapsed or progressed with a TTP >=6 months. Relapsed disease is defined as documented disease progression using the International Workshop Response Criteria (IWRC). Bidimensionally measurable disease with at least 1 lesion >=2.0 cm in a single dimension. Acceptable hematologic, hepatic, and renal function. Key Exclusion Criteria: Any lymphoma therapy between Final Visit on Study 114-NH-301 and Study Day 1 of this retreatment study. Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1. Transfusion-dependent subjects. Presence of central nervous system (CNS) lymphoma. Histologic transformation. Presence of pleural or peritoneal effusion with positive cytology for lymphoma. Another primary malignancy requiring active treatment. Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions that 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	NCT00384150
Other Study ID Numbers ^ICMJE	114-NH-302
Has Data Monitoring Committee	No
Responsible Party	Biogen Idec, M.D., Biogen Idec
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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