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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin's

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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galiximab in combination with rituximab

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

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Other Identifiers

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114-NH-302

Identifier Type: -

Identifier Source: org_study_id