Relapsed, Follicular Non-Hodgkin’s Lymphoma MedDRA version: 9.1 Level: LLT Classification code 10029547 Term: Non-Hodgkin's lymphoma
Conditions
Interventions
Product Name: Galiximab
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: Galiximab
Other descriptive name: IDEC 114, anti-CD80, anti-B7.1
Concentration unit: mg/ml mil
Sponsors
Biogen Idec Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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). | — |
Countries
Austria, Czech Republic, Italy, Latvia, Lithuania, Spain, Sweden, United Kingdom
Outcome results
None listed