A phase III, randomised, double blind study of galiximab in combination with rituximab compared with rituximab in combination with placebo for the treatment of subjects with Relapsed or Refractory, follicular Non-Hodgkin's Lymphoma
- Conditions
- Relapsed or refractory follicular NHLMedDRA version: 14.1Level: PTClassification code 10016905Term: Follicle centre lymphoma, follicular grade I, II, III recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2005-003836-22-IT
- Lead Sponsor
- Biogen Idec Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
1. Must give written informed consent and any authorizations as required by local law (e.g., Protected Health Information [PHI] for North America) 2. Aged ³ 18 years old at the time of informed consent 3. Histologically confirmed follicular NHL Grade 1-3a (if the subject has received any intervening lymphoma therapy since the most recent biopsy, a repeat biopsy will be required to exclude transformation) 4. Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment as determined by one of the following: · Documented disease progression by CT scan using the International Workshop Response Criteria (IWRC) as described in Appendix C on the protocol · The presence of B symptoms · Bulky disease (at least 1 lesion >5 cm) · Laboratory abnormalities (cytopenias or elevated LDH) · Presence of masses which are causing ongoing clinical symptoms 5. Bidimensionally measurable disease with at least 1 lesion ³ 2.0 cm in a single dimension 6. Hematologic, hepatic, and renal function parameters satisfying the following: · Bilirubin £ 2.0 mg/dL · AST (SGOT) £ 2 ´ upper limit of normal (ULN) and ALT (SGPT) £ 2 ´ ULN · Serum creatinine £ 2.0 mg/dL · Hemoglobin ³ 8.0 g/dL · Absolute neutrophil count ³ 1500 cells/mm3 · Platelet count ³ 75,000 plts/mm3 7. WHO Performance Status £ 2 8. 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 9. Expected survival of ³ 3 months 10. 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: 0
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
1. Follicular lymphoma Grade 3b 2. Previous exposure to galiximab or any anti CD80 antibody 3. Known hypersensitivity to murine proteins 4. 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) 5. Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to Study Day 1 (6 weeks if nitrosourea or mitomycin C) 6. Prior lymphoma vaccine therapy within 12 months prior to Study Day 1 7. Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1 8. Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1 9. Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1 10. Prior allogeneic transplant 11. Transfusion-dependent subjects 12. Known history of hepatitis or hepatic disease. (Although testing for hepatitis B is not mandatory, this should be considered for all subjects considered at high risk for hepatitis B infection and in endemic areas. Subjects with any serological evidence of current or past hepatitis B exposure should be excluded unless the serological findings are clearly due to vaccination.) 13. Presence of chronic lymphocytic leukemia (CLL), marginal zone lymphoma, mucosa associated lymphoid tissue (MALT) 14. Presence of central nervous system (CNS) lymphoma 15. Known history of HIV infection or AIDS 16. Prior diagnosis of aggressive NHL or mantle cell lymphoma 17. Histologic transformation 18. Presence of pleural or peritoneal effusion with positive cytology for lymphoma 19. Another primary malignancy requiring active treatment (except hormonal therapy) 20. 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 21. New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1 22. Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1 23. History of alcoholism or substance abuse within the 2 years prior to Study Day 1 24. 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 compare the clinical benefit of galiximab in combination with rituximab with that of rituximab monotherapy for the treatment of subjects with relapsed or refractory, follicular NHL.;Secondary Objective: · To further characterize the safety profile of galiximab in combination with rituximab. · To further characterize the pharmacokinetics (PK) of 4 infusions of galiximab in combination with rituximab.;Primary end point(s): Progression free survival
- Secondary Outcome Measures
Name Time Method