Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL) - Full Text View

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00384150

Purpose

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.

Condition	Intervention	Phase
Non-Hodgkin Lymphoma	Drug: galiximab in combination with rituximab	Phase III

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab Immunoglobulins Globulin, Immune Galiximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	345
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Intervention Details:

galiximab (500 mg/m2 IV) in combination with rituximab (375 mg/m2 IV)once weekly for 4 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384150

Show 123 Study Locations

Sponsors and Collaborators

Biogen Idec

More Information

Responsible Party:	Biogen Idec ( Biogen Idec, M.D. )
Study ID Numbers:	114-NH-302
Study First Received:	October 4, 2006
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00384150
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

NHL
follicular
refractory
relapsed

antibody
rituximab
galiximab
retreatment

Study placed in the following topic categories:

Lymphatic Diseases
Antibodies
Immunoproliferative Disorders
Rituximab
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Follicular lymphoma
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009