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

Primary Purpose

Lymphoma, Non-Hodgkin's

Status

Terminated

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

galiximab in combination with rituximab

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin's focused on measuring galiximab, antibody, refractory, follicular, relapsed, NHL, rituximab, retreatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies

Secondary Outcome Measures

Pharmacokinetics

To further characterize the efficacy profile of galiximab in combination with rituximab

Full Information

NCT ID

NCT00384150

First Posted

October 4, 2006

Last Updated

October 30, 2015

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT00384150

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Why Stopped

Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.

Study Start Date

November 2007 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Non-Hodgkin's

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

galiximab in combination with rituximab

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies

Time Frame

Study period is approx. 2 years

Secondary Outcome Measure Information:

Title

Pharmacokinetics

Time Frame

Study period is approx. 2 years

Title

To further characterize the efficacy profile of galiximab in combination with rituximab

Time Frame

Study period is approx. 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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