Clinical trial NCT00363636: A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lymphoma, Non-Hodgkin's
Keywords: relapsed
NHL
pharmacokinetics
antibody
safety
galiximab
efficacy
rituximab
refractory
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: To assess efficacy as measured by progression free survival (PFS), and determine whether rituximab plus galiximab compared to rituximab plus placebo may extend PFS.
timeFrame: The duration of this study is approx 4 years
Secondary outcomes:
measure: Secondary efficacy measures include: event-free survival, time to progression, duration of response, complete response rate, and overall survival.
timeFrame: The duration of this study is approx 4 years
measure: Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies.
timeFrame: The duration of this study is approx 4 years
measure: Pharmacokinetics
timeFrame: The duration of this study is approx 4 years
measure: Quality of Life using both the Functional Assessment of Cancer Therapy-Lymphoma (FACT-lym) and the EQ-5D (EuroQoL) instruments
timeFrame: The duration of this study is approx 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: