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

NCT00363636 | Terminated Phase 3 DMC

• 1 other identifier: 114-NH-301
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase III, multicenter, global, clinical study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with follicular NHL. The purpose of the study is to compare the clinical benefit of galiximab when given in combination with rituximab as compared with rituximab alone (given with placebo) in subjects with follicular NHL. Safety and pharmacokinetics (PK) of galiximab and rituximab will also be evaluated.

Conditions

Lymphoma, Non-Hodgkin's

Keywords

relapsed; NHL; pharmacokinetics; antibody; safety; galiximab; efficacy; rituximab; refractory

Outcome Measures

Primary Outcomes (1)

• To assess efficacy as measured by progression free survival (PFS), and determine whether rituximab plus galiximab compared to rituximab plus placebo may extend PFS.

  The duration of this study is approx 4 years

Secondary Outcomes (4)

• Secondary efficacy measures include: event-free survival, time to progression, duration of response, complete response rate, and overall survival.

  The duration of this study is approx 4 years

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

  The duration of this study is approx 4 years

• Pharmacokinetics

  The duration of this study is approx 4 years

• Quality of Life using both the Functional Assessment of Cancer Therapy-Lymphoma (FACT-lym) and the EQ-5D (EuroQoL) instruments

  The duration of this study is approx 4 years

Study Arms (2)

1

EXPERIMENTAL

Drug: Galiximab in combination with rituximab

2

ACTIVE COMPARATOR

Drug: Rituximab in combination with placebo

Interventions

Galiximab in combination with rituximab DRUG

Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4

1

Rituximab in combination with placebo DRUG

Rituximab (375 mg/m2 IV) in combination with placebo, weekly x 4

2

Eligibility Criteria

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

You may qualify if:

• Aged \>= 18 years old at the time of informed consent.
• Histologically confirmed follicular Grade 1-3a NHL.
• Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment.
• Bidimensionally measurable disease with at least 1 lesion \>= 2.0 cm in a single dimension.
• Acceptable hematologic, hepatic, and renal function parameters.
• Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs.

You may not qualify if:

• Follicular lymphoma Grade 3b.
• Rituximab refractory or refractory to anti-CD20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a TTP of less than 6 months).
• Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to Study Day 1 (6 weeks if nitrosourea or mitomycin C).
• Prior lymphoma vaccine therapy within 12 months prior to Study Day 1.
• Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1.
• Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1.
• Prior allogeneic transplant.
• Transfusion-dependent subjects.
• Another primary malignancy requiring active treatment (except hormonal therapy).
• Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which 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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: September 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 2, 2015

Record last verified: 2011-03