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

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ClinicalTrials.gov Identifier: NCT00363636
Recruitment Status : Terminated (Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.)
First Posted : August 15, 2006
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:

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 or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin's Drug: Galiximab in combination with rituximab Drug: Rituximab in combination with placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
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
Study Start Date : September 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. Pharmacokinetics [ Time Frame: The duration of this study is approx 4 years ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363636


Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00363636     History of Changes
Other Study ID Numbers: 114-NH-301
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: March 2011

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

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