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

October 30, 2015 updated by: Biogen

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

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.

Study Overview

Status

Terminated

Conditions

Lymphoma, Non-Hodgkin's

Intervention / Treatment

Drug: galiximab in combination with rituximab

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Study period is approx. 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics Time Frame: Study period is approx. 2 years	Study period is approx. 2 years
To further characterize the efficacy profile of galiximab in combination with rituximab Time Frame: Study period is approx. 2 years	Study period is approx. 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

October 4, 2006

First Submitted That Met QC Criteria