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

• Conditions: Relapsed, Follicular Non-Hodgkin’s Lymphoma; MedDRA version: 9.1Level: LLTClassification code 10029547Term: Non-Hodgkin's lymphoma

• Registration Number: EUCTR2006-003987-74-LV
• Lead Sponsor: Biogen Idec Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-11
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

To be considered for registration and randomization into this study, subjects must satisfy all of the following criteria:
1. Must give written informed consent and any authorizations as required by local law (e.g., Protected Health Information [PHI] for North America)
2. Demonstrated a response (CR, CRu, or PR) on Study 114-NH-301 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) as described in Appendix C of the protocol
3.Bidimensionally measurable disease with at least 1 lesion =2.0 cm in a single
dimension
4.Hematologic, hepatic and renal function parameters satisfying the following:
a. Bilirubin =2.0 mg/dL
b. AST (SGOT) =2 X upper limit of normal (ULN) and ALT (SGPT) =2 X ULN
c. Serum creatinine =2.0 mg/dL
d. Hemoglobin =8.0 g/dL
e. Absolute neutrophil count =1500 cells/mm3
f. Platelet count =75,000 plts/mm3
5. WHO Performance Status =2
6. Expected survival of =3 months
7. Subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Unless otherwise specified, candidates will be excluded from study entry if any of the
following exclusion criteria exist at the time of registration:

1. Any lymphoma therapy between Final Visit on Study 114 NH 301 and Study Day 1 of this retreatment study
2. Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1
3. Transfusion-dependent subjects
4. Presence of central nervous system (CNS) lymphoma
5. Histologic transformation
6. Presence of pleural or peritoneal effusion with positive cytology for lymphoma
7. Another primary malignancy requiring active treatment
8. 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
9. New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1
10. Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1
11. History of alcoholism or substance abuse within the 2 years prior to Study Day 1
12. Pregnant or currently breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety of repeat or initial treatment with galiximab in combination with rituximab after relapse in the pivotal Phase III study (114-NH-301);Secondary Objective: To further characterize the pharmacokinetics (PK) of repeat or initial treatment with galiximab in combination with rituximab<br>To further characterize the efficacy profile of galiximab in combination with rituximab;Primary end point(s): The primary study endpoint is Progression-Free Survival (PFS).