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

September 17, 2015 updated by: Biogen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

340

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

No

Genders Eligible for Study

All

Description

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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Galiximab in combination with rituximab
Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4
Active Comparator: 2
Drug: Rituximab in combination with placebo
Rituximab (375 mg/m2 IV) in combination with placebo, weekly x 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
The duration of this study is approx 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
The duration of this study is approx 4 years
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
The duration of this study is approx 4 years
Pharmacokinetics
Time Frame: The duration of this study is approx 4 years
The duration of this study is approx 4 years
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
The duration of this study is approx 4 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

September 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

August 11, 2006

First Submitted That Met QC Criteria

August 11, 2006

First Posted (Estimate)

August 15, 2006

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114-NH-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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