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

NCT00384150 | Terminated Phase 3

• 1 other identifier: 114-NH-302
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphoma, Non-Hodgkin's

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Interventions

galiximab in combination with rituximab DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Recurrence

Interventions

galiximab; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2006
• First Posted: October 5, 2006
• Study Start: November 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: November 26, 2015

Record last verified: 2015-10