- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00363636
A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4
|
Active Comparator: 2
|
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
- Galiximab
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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