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.)
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00363636
First received: August 11, 2006
Last updated: March 17, 2011
Last verified: March 2011
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Idec:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: The duration of this study is approx 4 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

  Eligibility

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

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00363636     History of Changes
Other Study ID Numbers: 114-NH-301
Study First Received: August 11, 2006
Last Updated: March 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
relapsed
NHL
pharmacokinetics
antibody
safety
galiximab
efficacy
rituximab
refractory

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014