Lymphoma, Non-Hodgkin's
Conditions
Keywords
relapsed, NHL, pharmacokinetics, antibody, safety, galiximab, efficacy, rituximab, refractory
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.
Interventions
Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4
DRUGRituximab in combination with placebo
Rituximab (375 mg/m2 IV) in combination with placebo, weekly x 4
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| 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. | The duration of this study is approx 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy measures include: event-free survival, time to progression, duration of response, complete response rate, and overall survival. | 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. | The duration of this study is approx 4 years |
| Pharmacokinetics | 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 | The duration of this study is approx 4 years |
Outcome results
None listed