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

Lymphoma, Non-Hodgkin's Clinical Trial

Official title:

A Phase III, Open-Label, Multicenter, Single-Arm, Retreatment Study of Galiximab in Combination With Rituximab for Subjects With Relapsed, Follicular Non-Hodgkin's Lymphoma Who Previously Responded on Study 114-NH-301

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00384150
• Other study ID #: 114-NH-302
• Status: Terminated
• Phase: Phase 3
• First received: October 4, 2006
• Last updated: October 30, 2015
• Start date: November 2007
• Est. completion date: January 2010

Study information

• Verified date: October 2015
• 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, open-label, single-arm, retreatment study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with relapsed or refractory, follicular NHL who demonstrated a response on Study 114-NH-301 with a time-to-progression >=6 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Demonstrated a response (CR, CRu, or PR) on Study 114-NH-301 (Galiximab in combination with Rituximab compared with Rituximab in combination with Placebo) and then relapsed or progressed with a TTP >=6 months. Relapsed disease is defined as documented disease progression using the International Workshop Response Criteria (IWRC).

• Bidimensionally measurable disease with at least 1 lesion >=2.0 cm in a single dimension.

• Acceptable hematologic, hepatic, and renal function.

Key Exclusion Criteria:

• Any lymphoma therapy between Final Visit on Study 114-NH-301 and Study Day 1 of this retreatment study.

• Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1.

• Transfusion-dependent subjects.

• Presence of central nervous system (CNS) lymphoma.

• Histologic transformation.

• Presence of pleural or peritoneal effusion with positive cytology for lymphoma.

• Another primary malignancy requiring active treatment.

• Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions that 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: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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 (500 mg/m2 IV) in combination with rituximab (375 mg/m2 IV)once weekly for 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies		Study period is approx. 2 years	Yes
Secondary	Pharmacokinetics		Study period is approx. 2 years	No
Secondary	To further characterize the efficacy profile of galiximab in combination with rituximab		Study period is approx. 2 years	No