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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.)
Information provided by (Responsible Party):
Biogen Identifier:
First received: August 11, 2006
Last updated: September 17, 2015
Last verified: March 2011

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.

Condition Intervention Phase
Lymphoma, Non-Hodgkin's Drug: Galiximab in combination with rituximab Drug: Rituximab in combination with placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • Pharmacokinetics [ Time Frame: 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 ]

Enrollment: 340
Study Start Date: September 2006
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00363636

Sponsors and Collaborators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen Identifier: NCT00363636     History of Changes
Other Study ID Numbers: 114-NH-301
Study First Received: August 11, 2006
Last Updated: September 17, 2015

Keywords provided by Biogen:

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on August 18, 2017