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

Lymphoma, Non-Hodgkin's Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00363636
• Other study ID #: 114-NH-301
• Status: Terminated
• Phase: Phase 3
• First received: August 11, 2006
• Last updated: September 17, 2015
• Start date: September 2006
• Est. completion date: April 2010

Study information

• Verified date: March 2011
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 340
• Est. completion date: April 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• Lymphoma, Non-Hodgkin's

Intervention

Drug:
• Galiximab in combination with rituximab
Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4
• Rituximab in combination with placebo
Rituximab (375 mg/m2 IV) in combination with placebo, weekly x 4

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	Pharmacokinetics		The duration of this study is approx 4 years	No
Secondary	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	No