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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00384150

Enrollment

Registered

2006-10-05

Start date

2007-11-30

Completion date

2010-01-31

Last updated

2015-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Non-Hodgkin's

Keywords

galiximab, antibody, refractory, follicular, relapsed, NHL, rituximab, retreatment

Brief 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.

Interventions

DRUGgaliximab in combination with rituximab

galiximab (500 mg/m2 IV) in combination with rituximab (375 mg/m2 IV)once weekly for 4 weeks.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies	Study period is approx. 2 years

Secondary

Measure	Time frame
Pharmacokinetics	Study period is approx. 2 years
To further characterize the efficacy profile of galiximab in combination with rituximab	Study period is approx. 2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026